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A number of pharmacologic treatments examined in recent r and omized clinical trials ( RCTs ) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated . Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies , such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ( “ assay sensitivity ” ) . Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development . Therefore , an Initiative on Methods , Measurement , and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was review ed and discussed . On the basis of this meeting and subsequent discussion s , the authors recommend consideration of a number of patient , study design , study site , and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments . Increased attention to and research on method ological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence ‐based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety Study Design An inception cohort design was used in which 421 patients were evaluated systematic ally with a st and ard battery of psychosocial assessment tests ( Structured Interview for DSM-III-R Diagnosis , Minnesota Multiphasic Personality Inventory , and Million Visual Pain Analog Scale ) within 6 weeks of acute back pain onset . Objectives The present study evaluated the predictive power of a comprehensive assessment of psychosocial and personality factors in identifying acute low back pain patients who subsequently develop chronic pain disability problems  ( as measured by job-work status at 1-year follow-up evaluation ) . Summary of Background Data There has been a relative paucity of prospect i ve research in the United States comprehensively evaluating potential psychoscial risk factors that are associated with those injured workers who subsequently fail to return to work and productivity after 1 year because of low back pain disability . Such research has been quite limited because of the time and cost involved in conducting prospect i ve studies . Methods All study patients were symptomatic with lumbar pain syndrome for no more than 6 weeks , These acute patients were tracked every 3 months , culminating in a structured telephone interview being conducted 1 year after the initial evaluation to document return-to-work status . Results Logistic regression analyses , conducted to differentiate between patients who were back at work after 1 year versus patients who were not because of the original back injury , revealed the importance of three psychosocial measures : self-reported pain and disability , scores on Scale 3 of the Minnesota Multiphasic Personality Inventory , and workers ' compensation and personal injury insurance status . The model generated correctly classified 90.7 % of the cases . Results revealed that major psychopathology , such as depression and substance abuse , did not precede or cause the development of chronic pain disability . Conclusions These results show the presence of a robust “ psychosocial disability factor ” that is associated with those injured workers who are likely to develop chronic low back pain disability problems .  Based on these data , a statistical algorithm has been generated that can identify those acute patients who will require early intervention to prevent the development of chronic disability . The second major result is that preinjury or concomitant psychopathology does not appear to predispose patients to chronic pain disability , although high rates of psychopathology have been shown in chronic low back pain . Future research should be directed at emotional vulnerability and psychosocial events in the period after the injury that may lead to chronicity AFTER surgical procedures such as amputation , mastectomy , and thoracotomy , as many as 60 % of patients continue to experience pain for at least 6 months , with approximately 10 % reporting severe pain . These chronic postsurgical pain conditions have major adverse effects on health-related quality of life , including physical functioning and emotional well-being . Unfortunately , the efficacy of existing treatments is limited and many patients remain refractory to currently available therapies . For this reason , the development of interventions that prevent chronic pain after surgery has the potential to have a major impact on public health . Substantial attention has been devoted to the hypothesis that the incidence of chronic postsurgical pain can be reduced by “ preventive ” analgesia , and the benefits of preoperative , intraoperative , and postoperative analgesic interventions have been investigated alone and in various combinations . Although the results of these studies suggest that reduced acute pain and analgesic consumption can extend beyond the duration of action of the preventive analgesic interventions , there is little evidence that chronic postsurgical pain can be prevented . Placebocontrolled r and omized clinical trials are needed to determine what specific analgesic interventions are efficacious for preventing chronic pain after what types of surgery for which patients . – 6 A critical component of future clinical trials will involve determining the clinical importance of the benefits of preventive analgesia . The results of recent studies and consensus recommendations provide a foundation for interpreting the benefits of chronic pain treatment ; however , little attention has been paid to determining what magnitudes of chronic pain prevention are clinical ly meaningful . As is true of treatment benefits , evaluating the importance of preventive benefits involves a frequently misunderstood distinction between the interpretation of the clinical importance of individual patient benefits and the interpretation of the clinical importance of group differences . The results of multiple studies have shown that individual patients consider chronic pain reductions of at least 30 % on numerical or visual analog scales to be moderately clinical ly important , whereas reductions of at least 50 % represent substantial improvements . These thresholds are based on ratings by patients of their own improvement at the end of chronic pain trials , and consistent results have been found across different chronic pain conditions and in patients administered active treatments as well as placebo . Criteria for identifying clinical ly meaningful individual improvements are necessary to categorize patients as “ responders ” or “ nonresponders , ” which makes it possible to compare the percentages of patients who achieve clinical ly important outcomes between different treatment and comparison groups . Unfortunately , criteria for determining clinical ly important improvements in patients being treated for chronic pain can not be extrapolated to those undergoing perioperative analgesic interventions to prevent chronic pain . Currently , there are no data that make it possible to determine whether patients who have not experienced chronic pain would consider its prevention after surgery important enough to undergo preoperative , intraoperative , and postoperative analgesic interventions . Evaluations of individual patient improvements associated with chronic pain treatments have emphasized pain reduction , but patients considering the prevention of conditions for which their risk is relatively low can also be expected to be particularly concerned with the adverse effects , safety risks , inconvenience , and costs of the preventive intervention . It is likely that an efficacious preventive analgesia would not completely prevent chronic pain but would instead partially reduce its incidence , intensity , or duration . Such partial preventive benefits would , of course , be even harder for patients to evaluate ; for example , would patients consider reducing pain intensity 6 months after surgery from a daily average of 4 to 2 on a 0–10 scale a clinical ly important benefit ? Would this evaluation change if this reduction in pain intensity at 6 months is known to last for another 2 yr , or if the preventive intervention requires that patients take a medication that causes sedation , nausea , and constipation for 7 days before and 30 days after their operation ? Evaluations of the clinical importance of preventive analgesia must reflect the magnitude of the reductions in chronic pain incidence , intensity , or duration that the intervention would provide . However , even small reductions in the incidence or intensity of a chronic pain condition that can last for months or even years might be considered clinical ly important by patients if Accepted for publication November 17 , 2009 . The authors are not supported by , nor maintain any financial interest in , any commercial activity that may be associated with the topic of this article OBJECTIVE All occupations expose workers to varied and unique conditions . The nature of work has been recognized as influencing the health of workers . Whether predictors for chronic neck and low back pain would be occupation-specific is unknown . This study aim ed to identify predictors for chronic neck and low back pain in a cohort of office workers . METHODS A prospect i ve study was carried out among 669 healthy office workers . At baseline , risk factors were assessed using a question naire and st and ardized physical examination . A symptomatic case was defined as an individual who reported pain greater than 30 mm on a 100-mm VAS , and chronic pain was defined as experiencing ongoing neck or low back pain for greater than 3 months over the past 6 months . Two regression models were built to analyze the risk factors for developing chronic neck and low back pain . RESULTS Of the sample , 17 and 27 % of office workers who reported a new onset of neck or low back pain developed chronicity , respectively . Predictors for chronic neck pain were high body mass index , frequent neck extension during the work day , high initial pain intensity , and high psychological job dem and s. The development of chronic low back pain was associated with history of low back pain and high initial pain intensity . CONCLUSIONS The findings suggest that predictors for chronic musculoskeletal pain in a sub population may be a subset of predictors identified in a general population or occupation specific . Successful management to prevent chronic musculoskeletal pain may also need to consider the patient 's occupation Introduction Low back pain ( LBP ) is the leading cause of disability worldwide . Of those patients who present to primary care with acute LBP , 40 % continue to report symptoms 3 months later and develop chronic LBP . Although it is possible to identify these patients early , effective interventions to improve their outcomes are not available . This double-blind ( participant/ outcome assessor ) r and omised controlled trial will investigate the efficacy of a brief educational approach to prevent chronic LBP in ‘ at-risk ’ individuals . Methods / analysis Participants will be recruited from primary care practice s in the Sydney metropolitan area . To be eligible for inclusion participants will be aged 18–75 years , with acute LBP ( < 4 weeks ’ duration ) preceded by at least a 1 month pain-free period and at-risk of developing chronic LBP . Potential participants with chronic spinal pain and those with suspected serious spinal pathology will be excluded . Eligible participants who agree to take part will be r and omly allocated to receive 2 × 1 h sessions of pain biology education or 2 × 1 h sessions of sham education from a specially trained study physiotherapist . The study requires 101 participants per group to detect a 1-point difference in pain intensity 3 months after pain onset . Secondary outcomes include the incidence of chronic LBP , disability , pain intensity , depression , healthcare utilisation , pain attitudes and beliefs , global recovery and recurrence and are measured at 1 week post-intervention , and at 3 , 6 and 12 months post LBP onset . Ethics/dissemination Ethical approval was obtained from the University of New South Wales Human Ethics Committee in June 2013 ( ref number HC12664 ) . Outcomes will be disseminated through publication in peer- review ed journals and presentations at international conference meetings . Trial registration number https://www.anzctr.org.au/Trial/ Registration /Trial Review There is a serious need to provide effective early interventions that prevent the development of persistent pain and disability . Identifying patients at risk for this development is an important step . Our aim was to explore whether distinct subgroups of individuals with similar response patterns on a screening question naire exist . Moreover , the objective was to then relate these groups to future outcomes , for example , sick leave as an impetus for developing tailored interventions that might better prevent chronic problems . A total of 363 patients seeking primary care for acute or subacute spinal pain completed the Örebro Musculoskeletal Pain Screening Question naire  and were then followed to determine outcome . Cluster analysis was used to identify subgroups . Validity was tested using 3 methods including the split-half technique . The subgroups were compared prospect ively on outcome measures obtained 1 year later . Using pain intensity , fear-avoidance beliefs , function , and mood , we found 4 distinct profiles : Fear-Avoidant , Distressed Fear-Avoidant , Low Risk , and Low Risk-Depressed Mood . These 4 subgroups were also robust in all 3 of the validity procedures . The 4 subgroups were clearly related to outcome . Although the low risk profiles had virtually no one developing long-term sick leave , the Fear-Avoidant profile had 35 % and the Distressed Fear-Avoidant profile 62 % developing long-term sick leave . Our results suggest that fear-avoidance and distress are important factors in the development of pain-related disability and may serve as a key for early identification . Providing interventions specific to the factors isolated in the profiles should enhance the prevention of persistent pain and disability STUDY DESIGN An investigation of the efficacy of an individually scheduled , risk factor-based cognitive behavioral therapy and a st and ardized electromyographic biofeedback intervention in the prevention of chronicity in patients with acute sciatica and psychosocial risk factors for chronicity . OBJECTIVES To investigate the possibility of enhancing pain relief and preventing chronicity in patients with acute sciatica , based on a screening for psychosocial high-risk factors of chronification . SUMMARY OF BACKGROUND DATA Psychological interventions were evaluated mainly in patients with chronic low back pain . Numerous r and omized trials have demonstrated their efficacy , whereas the amount of pain relief was found to be marginal . METHODS Subjective and behavioral outcome parameters were compared with the respective parameters in age- , gender- , and diagnosis-matched high- and low-risk patients . No additional behavioral treatment for in-patient medical therapy was offered to the patients . Outcome of these patients also was compared with that of a group of refusers of behavioral therapy .  Psychological , functional , and behavioral variables were measured before and after treatment and at 3- , 6- , 12- and 18-month follow-up visits . Changes over time , group differences , and possible group x time interactions were analyzed by analysis of variance and nonparameteric comparisons . RESULTS Data analysis showed a statistically and clinical ly significant , beneficial effect of both behavioral interventions . However , risk factor-based cognitive behavioral therapy was superior to electromyographic biofeedback intervention with respect to pain relief and application for early retirement . The cognitive behavioral therapy showed a similar good outcome ( e.g. , 90 % showed a clinical significant pain reduction ) as the low-risk patients ( 83 % pain reduction ) . High risk patients and refusers of therapy showed a poor outcome in pain ( 33 % and 20 % pain reduction , respectively ) , disability , and work performance . CONCLUSIONS Individually scheduled , risk factor-based cognitive behavior therapy could be a beneficial treatment modality , which can be offered , in addition to a medical treatment , to patients with acute sciatica and psychosocial high risk factors for chronicity . It may be an effective way to prevent chronification in these patients & NA ; Current conceptions of chronic pain clearly suggest that proper care at the acute stage should prevent the development of chronic problems . Patients ( 198 ) seeking help for acute musculoskeletal pain ( MSP ) , e.g. , back and neck pain participated in two studies of the effects of an Early Active intervention which underscored ‘ well ’ behavior and function compared to a Treatment as Usual control group . The quantity of the Early Active treatment was a median of 1 doctor 's appointment and 3 meetings with a physical therapist .  Study I concerned patients with a prior history of sick‐listing for MSP , while study II involved patients with no prior history of MSP . Treatment satisfaction , pain experience , activities and sickness absenteeism were assessed before , after and at a 12‐month follow‐up . In study I ( patients with a history of MSP ) , the results showed significant improvements for both groups , but virtually no differences between the groups . Similarly , in study II ( no history of MSP ) both groups demonstrated significant improvements e.g. , for pain intensity and activity levels . However , the Early Active treatment result ed in significantly less sick‐listing relative to the control group . Moreover , the risk of developing chronic ( > 200 sick days ) pain was 8 times lower for the Early Activation group . This investigation shows that relatively simple changes in treatment result in reduced sickness absenteeism for ‘ first‐time ’ sufferers only . Consequently , the content and timing of treatment for pain appear to be crucial . Properly administered early intervention may therefore decrease sick leave and prevent chronic problems , thus saving considerable re sources In an attempt to prevent acute low-back pain from becoming a chronic disability problem , an earlier study developed a statistical algorithm which accurately identified those acute low-back pain patients who were at high risk for developing such chronicity . The major goal of the present study was to evaluate the clinical effectiveness of employing an early intervention program with these high-risk patients in order to prevent the development of chronic disability at a 1-year follow-up . Approximately 700 acute low-back pain patients were screened for their high-risk versus low-risk status . On the basis of this screening , high-risk patients were then r and omly assigned to one of two groups : a functional restoration early intervention group ( n = 22 ) , or a nonintervention group ( n = 48 ) . A group of low-risk subjects ( n = 54 ) who did not receive any early intervention  was also evaluated . All these subjects were prospect ively tracked at 3-month intervals starting from the date of their initial evaluation , culminating in a 12-month follow-up . During these follow-up evaluations , pain disability and socioeconomic outcomes ( such as return-to-work and healthcare utilization ) were assessed . Results clearly indicated that the high-risk subjects who received early intervention displayed statistically significant fewer indices of chronic pain disability on a wide range of work , healthcare utilization , medication use , and self-report pain variables , relative to the high-risk subjects who do not receive such early intervention . In addition , the high-risk nonintervention group displayed significantly more symptoms of chronic pain disability on these variables relative to the initially low-risk subjects . Cost-comparison savings data were also evaluated . These data revealed that there were greater cost savings associated with the early intervention group versus the no early intervention group . The overall results of this study clearly demonstrate the treatment- and cost-effectiveness of an early intervention program for acute low-back pain patients Study Design . A r and omized controlled design superimposed on treatment as usual was used to compare the effects of a cognitive-behavior intervention aim ed at preventing chronicity with two different forms of information . Objective . To develop a coping-oriented preventive intervention applicable in primary care , and to compare its impact with educational information . Summary of Background Data . Preventing long-term disability result ing from spinal pain has proved difficult . The information provided by health care professions and early interventions aim ed at preventing long-term disability may be important , but little scientific evidence exists concerning their use . Methods . A protocol for a six-session cognitive-behavior group intervention was developed on the basis of earlier research . The main focus was to prevent long-term disability by changing patients ’ behaviors and beliefs so they can cope better with their problems . Comparison groups received either a pamphlet shown earlier to have an effect , or a more extensive information package consisting of six installments . All the groups continued to receive treatment as usual in primary care . There were 243 patients with acute or subacute spinal pain who perceived that they were at risk for developing a chronic problem . These patients were r and omized to the cognitive-behavioral intervention or one of the two information groups . Because the aim was to prevent long-term disability , the key outcome variables at the 1-year follow-up assessment were sick absenteeism and health care use . Other variables were pain , function , fear-avoidance beliefs , and cognitions . Results . The comparison groups reported benefits . However , the risk for a long-term sick absence developing was lowered ninefold for the cognitive-behavior intervention group as compared with the risk for the information groups ( relative risk , 9.3 ) . Participants in the cognitive-behavior group also reported a significant decrease in perceived risk . In addition , the cognitive-behavior group demonstrated a significant decrease in physician and physical therapy use as compared with two groups receiving information , in which such use increased . All three groups tended to improve on the variables of pain , fear-avoidance , and cognitions . Conclusions . This study demonstrates that a cognitive-behavior group intervention can lower the risk of a long-term disability developing . These findings underscore the significance of early interventions that specifically aim to prevent chronic problems . This approach might be applied to primary care setting UNLABELLED Chronic pain following breast cancer surgery is associated with decreased health-related quality of life and is a source of additional psychosocial distress in women who are already confronting the multiple stresses of cancer . Few prospect i ve studies have identified risk factors for chronic pain following breast cancer surgery . Putative demographic , clinical , and psychosocial risk factors for chronic pain were evaluated prospect ively in 95 women scheduled for breast cancer surgery . In a multivariate analysis of the presence of chronic pain , only younger age was associated with a significantly increased risk of developing chronic pain 3 months after surgery . In an analysis of the intensity of chronic pain , however , more invasive surgery , radiation therapy after surgery , and clinical ly meaningful acute postoperative pain each independently predicted more intense chronic pain 3 months after surgery . Preoperative emotional functioning variables did not independently contribute to the prediction of either the presence or the intensity of chronic pain after breast cancer surgery . These findings not only increase underst and ing of risk factors for chronic pain following breast cancer surgery and the processes that may contribute to its development but also provide a basis for the development of preventive interventions . PERSPECTIVE Clinical variables and severe acute pain were risk factors for chronic pain following breast cancer surgery , but psychosocial distress was not , which provides a basis for hypothesizing that aggressive management of acute postoperative pain may reduce chronic pain Chronic pain has been shown to affect up to 60 % of patients undergoing surgery for breast cancer . Besides younger age , other risk factors for the development of chronic pain have not been consistent in previous studies . The objective of the current investigation was to detect the prevalence and risk factors for the development of chronic pain  after breast cancer surgery by examining a patient population from a tertiary cancer center in the United States . The study was a prospect i ve observational cohort study . Subjects were evaluated at least 6 months after the surgical procedure . Subjects responded to the modified short form Brief pain inventory and the short form McGill pain question naire to identify and characterize pain . Demographic , surgery , cancer treatment , and perioperative characteristics were recorded . Propensity matching regression analysis were used to examine risk factors associated with the development of chronic pain .  300 patients were included in the study . 110 reported the presence of chronic pain .  Subjects with chronic pain reported median ( interquartile range [ IQR ] ) rating of worst pain in the last 24 hours of 4 ( 2 - 5 ) and a median ( IQR ) rating on average pain in the last 24 hours of 3 ( 1 - 4 ) on a 0 - 10 numeric rating scale . Independent risk factors associated with the development of chronic pain were age , OR ( 95 % CI ) of 0.95 ( 0.93 - 0.98 ) and axillary lymph node dissection , 7.7 ( 4.3 - 13.9 ) but not radiation therapy , 1.05(0.56 - 1.95 ) . After propensity matching for confounding covariates , radiation was still not associated with the development of chronic pain . Chronic pain after mastectomy continues to have a high prevalence in breast cancer patients . Younger age and axillary lymph node dissection but not radiation therapy are risk factors for the development of chronic pain . Preventive strategies to minimize the development of chronic pain are highly desirable Study Design . Prospect i ve cohort study with patients with chronic low back pain ( CLBP ) at primary care setting . Objective . The aim of our study was to identify predictors for transition from localized CLBP to chronic widespread pain in general practice . In contrast to the typically investigated risk factors , this study also focuses intensively on protective factors , which decrease the probability of chronic widespread pain . For this , we investigated the re sources resilience and coping strategies , which are suspected as potential protective factors for incident chronic pain syndromes . Summary of Background Data . In primary care , about a quarter of patients with CLBP experience chronic widespread pain ( CWP ) . Methods . Patients experiencing localized CLBP were included and evaluated after a 6- and 12-month follow-up period regarding the development of CWP . Potential risk factors (  sociodemographic data , pain characteristics , depression , anxiety , somatization ) , protective factors ( resilience , coping strategies ) , and sample characteristics were assessed at baseline . Predictor identification was done by multivariate logistic regression analysis . Results . The 1-year incidence for the onset of CWP among patients with CLBP was 23.8 % . We identified the 3 risk factors , female sex , long duration of back pain , and a high rate of psychosomatic symptoms , for the onset of CWP among patients with CLBP . Coping re sources and resilience had no impact on the transition from CLBP to CWP . Conclusion . The results suggest that CWP is no independent entity but rather a particularly negative occurrence on a continuum of chronic pain . Processes of somatization play a major role in the development of this extreme . Level of Evidence : Background Low back pain ( LBP ) and neck pain ( NP ) are a major public health problem with considerable costs for individuals , companies and society . Therefore , prevention is imperative . The Stay@Work study investigates the (cost-)effectiveness of Participatory Ergonomics ( PE ) to prevent LBP and NP among workers . Methods In a r and omised controlled trial ( RCT ) , a total of 5,759 workers working at 36 departments of four companies is expected to participate in the study at baseline . The departments consisting of about 150 workers are pre-stratified and r and omised . The control departments receive usual practice and the intervention departments receive PE . Within each intervention department a working group is formed including eight workers , a representative of the management , and an occupational health and safety coordinator . During a one day meeting , the working group follows the steps of PE in which the most important risk factors for LBP and NP , and the most adequate ergonomic measures are identified on the basis of group consensus . The implementation of ergonomic measures at the department is performed by the working group . To improve the implementation process , so-called ' ergocoaches ' are trained . The primary outcome measure is an episode of LBP and NP . Secondary outcome measures are actual use of ergonomic measures , physical workload , psychosocial workload , intensity of pain , general health status , sick leave , and work productivity . The cost-effectiveness analysis is performed from the societal and company perspective . Outcome measures are assessed using question naires at baseline and after 6 and 12 months . Data on the primary outcome as well as on intensity of pain , sick leave , work productivity , and health care costs are collected every 3 months . Discussion Prevention of LBP and NP is beneficial for workers , employers , and society . If the intervention is proven (cost-)effective , the intervention can have a major impact on LBP and NP prevention and , thereby , on work disability prevention . Results are expected in 2010.Trial registration IS RCT & NA ; The current investigation studied the effectiveness of a secondary prevention program for nurses with back pain who were deemed at risk for developing a chronic problem . A 2 × 3 repeated measures design was employed with 2 groups and 3 assessment periods . The treatment group received an intervention design ed to reduce current problems , but above all to prevent reinjury and minor pains from becoming chronic medical problems , and it included a physical and behavioral therapy package . The control group was placed on a waiting‐list . Results indicated that the treatment group had significantly greater improvements than the control group for pain intensity , anxiety , sleep quality and fatigue ratings , observed pain behavior , activities , mood , and helplessness . These differences were generally maintained at the 6 month follow‐up . In addition , the treatment group broke a trend for increasing amounts of pain‐related absenteeism , while the control group did not . Taken as a whole , the results suggest that a secondary prevention program aim ed at altering life style factors may represent an effective method for dealing with musculoskeletal pain problems Introduction The Multinational Musculoskeletal Inception Cohort Study ( MMICS ) Statement is a consensus statement aim ed at improving the quality of prospect i ve investigations into the transition from early stages of low back pain ( LBP ) to persistent problems . The statement aims to help improve the quality of such studies by recommending an agreed minimal list of measures for inclusion in baseline data collection . The MMICS Statement is primarily aim ed at research ers who want to investigate prognosis in LBP , and this will allow data from cohorts to be pooled and will facilitate comparisons between different health care systems . One approach to preventing acute new episodes of LBP ( up to 3 weeks from onset ) from developing into persistent disabling pain is to identify those individuals with LBP who are most likely to progress to chronic disability . Targeting interventions at those at highest risk could reduce the population burden of chronic LBP . A wide range of baseline parameters have been associated with poor outcome in inception cohort studies ( 1–6 ) . Few existing studies have been of sufficient size and method ologic rigor to produce conclusive findings . Even in method ologically robust studies , baseline factors only account for a small proportion of the variance in outcome ( 7 ) , typically around 30 % . Systematic review s of the literature could not pool data because studies used different measurements ( 1–3 ) . Despite some information on physical , psychosocial , and work-related risk factors , it has not been possible to adequately estimate the comparative impact of individual psychosocial and societal factors on the transition from acute to persistent disabling LBP . How to address this problem was one focus of the VI International Forum for Primary Care Research in Low Back Pain held in April 2003 . A steering group for the collaboration was appointed , and 8 national team leaders volunteered to recruit teams of national experts . Three additional team leaders were recruited by the steering group ( Australia , France , and Germany ) . Independent experts were invited to advise on the quality of the MMICS process . The MMICS steering group , located in the UK , met regularly and included expert research ers in clinical and outcome factors in back pain ( AB ) , work-related issues in back pain ( AKB ) , psychosocial aspects of back pain ( TP and RS ) , and general practice aspects of back pain ( MU ) . The MMICS Statement set out to include 1 ) a minimal but comprehensive number of predictor factors based on current evidence and theory ; 2 ) appropriate measurement instruments for agreed predictor factors based on their clinometric properties , availability , and practical characteristics ; and 3 ) a minimum set of followup measures , including recommendations about measurement and timing Background Persisting neck pain is common in society . It has been reported that the prevalence of neck pain in office workers is much higher than in the general population . The costs to the worker , employer and society associated with work-related neck pain are known to be considerable and are escalating . The factors that place office workers at greater risk of developing neck pain are not understood . The aim of this study is to investigate the incidence and risk factors of work-related neck pain in Australian office workers . Methods / design We will conduct a prospect i ve cohort study . A cohort of office workers without neck pain will be followed over a 12 month period , after baseline measurement of potential risk factors . The categories of risk factors being evaluated are physical ( cervical spine posture , range of movement , muscle endurance and exercise frequency ) , demographic ( age , sex ) , work environment ( sitting duration , frequency of breaks ) and psychosocial ( psychological distress and psychosocial work factors ) . Cox regression analysis will be used to identify risk factors associated with work-related neck pain , and will be expressed as hazard ratios with 95 % confidence intervals . The data will also enable the incidence of neck pain in this population to be estimated . Discussion In addition to clarifying the magnitude of this occupational health problem these data could inform policy in workplaces and provide the basis for primary prevention of neck pain in office workers , targeting the identified risk factors National Institutes of Health ( NIH ) consensus and state-of-the-science statements are prepared by independent panels of health professionals and public representatives on the basis of 1 ) the results of a systematic literature review prepared under contract with the Agency for Healthcare Research and Quality ( AHRQ ) , 2 ) presentations by investigators working in areas relevant to the conference questions during a 2-day public session , 3 ) questions and statements from conference attendees during open discussion periods that are part of the public session , and 4 ) closed deliberations by the panel during the remainder of the second day and the morning of the third . This statement is an independent report of the panel and is not a policy statement of the NIH or the federal government . The statement reflects the panel 's assessment of medical knowledge available at the time the statement was written . Thus , it provides a snapshot in time of the state of knowledge on the conference topic . When reading the statement , keep in mind that new knowledge is inevitably accumulating through medical research . At least half of American adults take a dietary supplement , the majority of which are multivitamin/multimineral ( MVM ) supplements . As more and more Americans seek strategies for maintaining good health and preventing disease , and as the marketplace offers an increasing number of products to fulfill that desire , it is important that consumers have the best possible information to make their choices . Assessing the available scientific evidence on the benefits of MVM supplement use for chronic disease prevention , identifying the gaps in the evidence , and recommending an appropriate research agenda to meet the shortfalls are subjects considered in this report . The word vitamine was coined in 1912 , as an abbreviated term meant to capture the notion of important factors in the diet , or vital amines . This was preceded more than 150 years earlier by British navy physician James Lind 's discoveryin the first recorded controlled trialthat citrus juice , a good source of what was found 2 centuries later to be vitamin C , could prevent scurvy in sailors . In 1913 , the first vitamin was isolated : thiamin , the deficiency of which caused beriberi . Thirteen vitamins and 15 essential minerals have now been identified as important to human nutrition . Large-scale fortification of diets began in the United States with the addition of iodine to table salt in 1924 to prevent goiter , followed by the addition of vitamin D to milk in 1933 to prevent rickets and the addition of thiamin , riboflavin , niacin , and iron to flour in 1941 . Multivitamin/multimineral products providing more than vitamins A and D became available in pharmacies and grocery stores in the mid-1930s . In the early 1940s , the first MVM tablet was introduced . Although clinical deficiency of vitamins or minerals , other than iron , is now uncommon in the United States , growth in supplement use has accelerated rapidly with marketing spurred by cl aims some based on scientific studies that chronic conditions could be prevented or treated by supplement use . Annual sales of supplements to Americans are now reported at about $ 23 billion , a substantial share of which is spent on vitamins and minerals . Because of such widespread use of MVM , increasing public and medical confusion over apparently contradictory results from studies , and reports of possible adverse effects from overuse in certain circumstances , the Office of Dietary Supplements and the Office of Medical Applications of Research of the NIH convened a State-of-the-Science Conference on Multivitamin/Mineral Supplements and Chronic Disease Prevention , held on 1517 May 2006 , in Bethesda , Maryl and . The goal of the conference was to assess the evidence available on MVM use and outcomes for chronic disease prevention in the generally healthy population of adults and to make recommendations for future research . The conference focused on vitamins and minerals and did not deal with botanicals , hormones , or other supplements . It also did not address the treatment of vitamin or mineral deficiencies . Except for considerations of safety , the conference also did not review issues of primary relevance to pregnant women or children . Specifically , the conference explored the following key questions : 1 ) What are the current patterns and prevalence of the public 's use of MVM supplements ? 2 ) What is known about the dietary nutrient intake of MVM users versus nonusers ? 3 ) What is the efficacy of single vitamin/mineral supplement use in chronic disease prevention ? 4 ) What is the efficacy of MVM  in chronic disease prevention in the general population of adults ? 5 ) What is known about the safety of MVM  for the generally healthy population ? and 6 ) What are the major knowledge gaps and research opportunities regarding MVM use ? During the first 2 days of the conference , experts presented information on each of the key questions . After weighing the scientific evidence , including the data presented by the speakers and a formal evidence report commissioned through AHRQ , an independent panel prepared and presented a draft of this state-of-the-science statement addressing the conference questions . The evidence report prepared for the conference is available at www.ahrq.gov/clinic/tp/multivittp.htm . For the purpose of this statement , the term MVM refers to any supplement containing 3 or more vitamins and minerals but no herbs , hormones , or drugs , with each component at a dose less than the tolerable upper level determined by the Food and Nutrition Boardthe maximum daily intake likely to pose no risk for adverse health effects . Our review also included studies of the relationship of single-nutrient supplements and 2-nutrient supplements to certain disease outcomes . The term primary prevention refers to preventing the development of disease in a person who does not have the disease in question . The chronic conditions assessed include cancer ; age-related sensory loss ; and cardiovascular , endocrine , neurologic , musculoskeletal , gastroenterologic , renal , and pulmonary diseases . A word is warranted about the nature of the evidence base considered by the panel . The range of vitamins and minerals of possible interest was so broad that the conference planning committee chose to focus the evidence report on nutrients for which the potential for impact had been most strongly suggested and on conditions for which supplements were thought to have the most potential influence . The planning committee also limited the scope of the evidence report to consideration of r and omized , controlled trials ( RCTs ) , which are generally considered the gold st and ard for evidence -based decision making . These are studies in which participants are allocated by chance alone to receive or not to receive 1 of 2 or more clinical interventions . For example , while folate supplementation was initially shown to decrease the risk for neural tube defects in animal studies , outcome data in nonhuman models were not considered sufficient evidence on which to base policy recommendations . At the next level of evidence , observational studies in humans suggested efficacy of folate supplementation to prevent such defects . However , these were criticized because they were not r and omized and were potentially subject to bias . Not until these findings were confirmed by RCTs in humans was public policy implemented , including fortification of cereal grains with folate . An observational study is one in which the exposure or treatment of interest is not assigned to the participant by the investigator . Such studies suggested that -carotene intake might protect against the development of some types of cancer . However , RCTs of -carotene supplementation not only showed no benefit , they also found an increased risk for lung cancer in persons who smoked cigarettes or who were exposed to asbestos . These examples illustrate both the risk of relying only on observational studies and the advantage of RCTs in identifying both benefits and risks of MVM supplementation . Limiting the focus of our statement to RCTs has some inherent limitations , given the potential of other types of studies to provide important insights . Observational studies , for example , are particularly useful for generating hypotheses , defining adverse effects , and documenting long-term treatment consequences . They are often essential precursors to the well-conducted RCTs important for policy formation . Our principal recommendations focus on the compelling research activities that must be supported to better inform the decisions that millions of Americans are making each day to use or not to use MVM supplements to prevent chronic disease . At the same time , mindful of the constraints of the available evidence base , we have also taken care not to make premature recommendations about whether generally healthy Americans should or should not take MVM supplements . Because of the need for more reliable information on MVMs , we have made strong recommendations for research and for increased U.S. Food and Drug Administration ( FDA ) oversight of the MVM industry . 1 . What Are the Current Patterns and Prevalence of the Public 's Use of MVM Supplements ? More than half of American adults take dietary supplements in the belief that they will make them feel better , give them greater energy , improve their health , and prevent and treat disease . The use of supplements has been steadily increasing , and growth appears likely to continue . Currently , users spend more than $ 23 billion per year on supplements , and among this supplement-using population , MVM is the major category of supplements , used by about one third of Americans . Uncertainty remains in estimating prevalence of use because of problems defining these products ; increasing complexity in the formulation of supplements , including more non-MVM components and specialized formulas ; and varying frequency of use . It appears that use is higher Study Design . Prospect i ve population -based cohort study . Objective . To identify early predictors of chronic work disability after work-related back injury . Summary of Background Data . Identification of early predictors of prolonged disability after back injury could increase underst and ing concerning the development of chronic , disabling pain , and aid in secondary prevention . Few studies have examined predictors across multiple domains in a large , population -based sample . Methods . Workers ( N = 1885 ) were interviewed 3 weeks ( average ) after su bmi tting a lost work-time cl aim for a back injury .  Sociodemographic , employment-related , pain and function , clinical , health care , administrative/legal , health behavior , and psychological domain variables were assessed via worker interviews , medical records , and administrative data bases . Logistic regression analyses identified early predictors of work disability compensation 1 year after cl aim su bmi ssion . Results . Significant baseline predictors of 1-year work disability in the final multidomain model were injury severity ( rated from medical records ) , specialty of the first health care provider seen for the injury ( obtained from administrative data ) , and worker-reported physical disability ( Rol and -Morris disability question naire ) , number of pain sites , “ very hectic ” job , no offer of a job accommodation ( e.g. , light duty ) , and previous injury involving a month or more off work . The model showed excellent ability to discriminate between workers who were/were not disabled at 1 year ( area under the receiver operating characteristic curve = 0.88 , 95 % CI = 0.86–0.90 ) . Conclusion . Among workers with new lost work-time back injury cl aims , risk factors for chronic disability include radiculopathy , substantial functional disability , and to a lesser extent , more widespread pain and previous injury with extended time off work . The roles of employers and health care providers also seem important , supporting the need to incorporate factors external to the worker in models of the development of chronic disability and in disability prevention efforts Background Patellofemoral pain syndrome is one of the most common chronic knee injuries ; however , little research has been done to determine the risk factors for this injury . Hypothesis Altered lower extremity kinematics and kinetics , decreased strength , and altered postural measurements will be risk factors . Study Design Cohort study ( prognosis ) ; Level of evidence , 2 . Methods A total of 1597 participants were enrolled in this investigation and prospect ively followed from the date of their enrollment ( July 2005 , July 2006 , or July 2007 ) through January 2008 , a maximum of 2.5 years of follow-up . Each participant underwent baseline data collection during their pre-freshman summer at the United States Naval Academy . Baseline data collection included 3-dimensional motion analysis during a jump-l and ing task , 6 lower extremity isometric strength tests , and postural alignment measurements ( navicular drop and Q angle ) . Results Risk factors for the development of patellofemoral pain syndrome included decreased knee flexion angle , decreased vertical ground-reaction force , and increased hip internal rotation angle during the jump-l and ing task . Additionally , decreased quadriceps and hamstring strength , increased hip external rotator strength , and increased navicular drop were risk factors for the development of patellofemoral pain syndrome . Conclusion Multiple modifiable risk factors for patellofemoral pain syndrome pain have been identified in this investigation . To decrease the incidence of this chronic injury , the risk factors for patellofemoral pain syndrome need to be targeted in injury prevention programs . Clinical Relevance Prevention programs should focus on increasing strength of the lower extremity musculature along with instructing proper mechanics during dynamic movements to decrease the incidence of patellofemoral pain syndrome High levels of pain , significant anxiety , or depressive symptoms before surgery put patients at elevated risk for chronic pain and prolonged opioid use following surgery . The purpose of this preliminary study was to assess the efficacy of a 1-day Acceptance and Commitment Therapy ( ACT ) workshop in " at-risk " veterans for the prevention of  chronic pain and opioid use following orthopedic surgery . In a r and omized controlled trial , 88 at-risk veterans undergoing orthopedic surgery were assigned to treatment as usual ( TAU ; n = 44 ) or TAU plus a 1-day ACT workshop ( n = 44 ) . Pain levels and opioid use were assessed up to 3 months following surgery . Pain acceptance and values-based behavior were assessed at baseline and 3-month follow-up . Participants who completed the ACT workshop reached pain and opioid cessation sooner than those in TAU .  Postoperative complications exhibited a moderating effect on these outcomes , such that the effects of ACT were greater in patients without complications . Increases in pain acceptance and values-based behavior , processes targeted in ACT , were related to better outcomes . These promising results merit further investigation in a larger clinical trial . Providing an intervention before surgery for at-risk veterans has the potential to change clinical practice from a focus on management of postoperative pain to prevention of chronic pain in at-risk individuals . PERSPECTIVE This pilot study compared the effects of a 1-day preventive behavioral intervention ( ACT ) to TAU in at-risk veterans undergoing orthopedic surgery . Three months following the intervention , veterans receiving ACT exhibited quicker cessation of pain and opioid use . Focusing on preoperative pain management may help prevent chronic postsurgical pain Study Design . A follow‐up study of a cohort of 444 patients aged 16 to 59 years who consulted with their general practitioners(GPs ) in 1987‐1988 for an incident episode of back pain . Objectives . To determine the proportion of patients with back pain in whom chronic back problems develop after a follow‐up of 7 years , to compare health outcomes and labor force participation of patients with and without chronic back problems and to identify determinants of chronicity . Summary of Background Data . The incidence and prevalence of back pain are very high . A large proportion of the costs related to medical consumption , absence from work , and disability are probably caused by chronic back problems . It is unknown what proportion of back problems become chronic , especially after a long follow‐up period , and which factors can predict chronicity . Methods . Data on the course of the symptoms and medical consumption from the period between 1987‐1988 and 1991 were gathered retrospectively . Data on several health outcomes , including LFP , and data on some work characteristics were collected prospect ively in 1991 . A more extensive data set on health outcomes including psychologic status and working situation was collected in 1994 . Results . Chronic back problems developed in 28 % of the patients . These patients reported more pain , higher levels of medical re source consumption , worse health outcomes , and lower labor force participation . Episodes of back pain before 1987‐1988 , severe pain in 1991 , and disability score in 1991 were positively associated with chronicity in 1994 , difficulties with job performance in 1991 , and frequent stooping in the subgroup of patients who held a paying job in the follow‐up period . Conclusions . Even after a follow‐up of 7 years , the proportion of people with chronic back problems was high . The consequences for quality of life , labor force participation , and consumption of medical re sources are clear . Further research is necessary to examine determinants and ways to prevent chronicity UNLABELLED Although previous research suggests that preamputation pain is a risk factor for pain after amputation , little is known about the association between acute postsurgical pain and chronic amputation-related pain . The current prospect i ve study examined the associations of preamputation pain and acute postamputation pain with chronic amputation-related pain . The sample consisted of patients with lower limb amputation ( N = 57 ) who provided both preamputation and postamputation data during a 2-year study period .  Preamputation pain intensity and duration  were assessed before  amputation ; acute phantom limb pain ( PLP ) and residual limb pain ( RLP ) intensity were assessed on postsurgical days 4 and 5 . Acute PLP intensity was the only significant independent predictor of chronic PLP intensity at 6 and 12 months after amputation , whereas preamputation pain intensity was the only significant predictor of chronic PLP intensity at 24 months . Similarly , acute RLP was found to be the best overall predictor of chronic RLP . Other variables ( age , gender , level and etiology of amputation , amount of postsurgical pain medication , and duration of preamputation pain ) were not associated with chronic pain . These results suggest that higher levels of pain either before or soon after amputation might help to identify individuals at greatest risk for chronic pain problems and most in need of early , intensive pain interventions . PERSPECTIVE This study suggests that both preamputation pain and acute pain soon after amputation might be associated with bothersome chronic pain . The results support further research on acute pain mechanisms and the effectiveness of early interventions aim ed at preventing or managing amputation-related pain & NA ; Background : Despite evidence suggesting that coping is an important concept in the study of pain , its role in predicting the development of disabling pain has not been previously studied . To assess the relationship between coping and the development of disabling pain . Methods : From a r and om sample of adults , we formed a cohort of individuals with non‐disabling neck and /or low back pain ( n=571 ) . Participants were followed 6 and 12 months after the index survey .  Coping  was measured with the V and erbilt Pain Management Inventory . The Chronic Pain Question naire was used to measure the presence of disabling neck and /or low back pain . We used Cox proportional hazards regression analyses to investigate the role of passive coping in the development of disabling pain while controlling for confounders . Results : Passive coping was a strong , independent risk factor for disabling neck and /or back pain . Those using moderate to high levels of passive coping strategies were at an over five‐fold increased risk of developing disabling pain ( Moderate : HRR=5.19 , 95 % CI=1.78–15.1 ; High : HRR=6.80 , 95 % CI=2.36–19.6 ) . Active coping was not found to be a significant risk factor for disabling neck and /or back pain . Conclusion : Passive coping is a strong and independent predictor of disabling neck and /or back pain . This strong relationship identifies passive coping as a marker for risk of disability and can allow for the identification of individuals at risk and in need of intervention to aid in improving their overall adjustment Background An ageing population , a growing prevalence of chronic diseases and limited financial re sources for health care underpin the importance of prevention of disabling health disorders and care dependency in the elderly . A wide variety of measures is generally available for the prevention of falls and fall-related injuries . The spectrum ranges from diagnostic procedures for identifying individuals at risk of falling to complex interventions for the removal or reduction of identified risk factors . However , the clinical and economic effectiveness of the majority of recommended strategies for fall prevention is unclear . Against this background , the literature analyses in this HTA report aim to support decision-making for effective and efficient fall prevention . Research questions The pivotal research question addresses the effectiveness of single interventions and complex programmes for the prevention of falls and fall-related injuries . The target population are the elderly ( > 60 years ) , living in their own housing or in long term care facilities . Further research questions refer to the cost-effectiveness of fall prevention measures , and their ethical , social and legal implication s. Methods Systematic literature search es were performed in 31 data bases covering the publication period from January 2003 to January 2010 . While the effectiveness of interventions is solely assessed on the basis of r and omised controlled trials ( RCT ) , the assessment of the effectiveness of diagnostic procedures also considers prospect i ve accuracy studies . In order to clarify social , ethical and legal aspects all studies deemed relevant with regard to content were taken into consideration , irrespective of their study design . Study selection and critical appraisal were conducted by two independent assessors . Due to clinical heterogeneity of the studies no meta-analyses were performed . Results Out of 12,000 references retrieved by literature search es , 184 meet the inclusion criteria . However , to a variable degree the validity of their results must be rated as compromised due to different biasing factors . In summary , it appears that the performance of tests or the application of parameters to identify individuals at risk of falling yields little or no clinical ly relevant information . Positive effects of exercise interventions  may be expected in relatively young and healthy seniors , while studies indicate opposite effects in the fragile elderly . For this specific vulnerable population the modification of the housing environment shows protective effects . A low number of studies , low quality of studies or inconsistent results lead to the conclusion that the effectiveness of the following interventions has to be rated unclear yet : correction of vision disorders , modification of psychotropic medication , vitamin D supplementation , nutritional supplements , psychological interventions , education of nursing personnel , multiple and multifactorial programs as well as the application of hip protectors . For the context of the German health care system the  economic evaluations of fall prevention  retrieved by the literature search es yield very few useful results . Cost-effectiveness calculations of fall prevention are mostly based on weak effectiveness data as well as on epidemiological and cost data from foreign health care systems . Ethical analysis demonstrates ambivalent views of the target population concerning fall risk and the necessity of fall prevention . The willingness to take up preventive measures depends on a variety of personal factors , the quality of information , guidance and decision-making , the prevention program itself and social support . The analysis of papers regarding legal issues shows three main challenges : the uncertainty of which st and ard of care has to be expected with regard to fall prevention , the necessity to consider the specific conditions of every single case when measures for fall prevention are applied , and the difficulty to balance the rights to autonomous decision making and physical integrity . Discussion and conclusions The assessment of clinical effectiveness of interventions for fall prevention is complicated by inherent method ological problems ( esp . absence of blinding ) and meaningful clinical heterogeneity of available studies . Therefore meta-analyses are not appropriate , and single study results are difficult to interpret . Both problems also impair the informative value of economic analyses . With this background it has to be stated that current recommendations regarding fall prevention in the elderly are not fully supported by scientific evidence . In particular , for the generation of new recommendations the dependency of probable effects on specific characteristics of the target population s or care setting s should be taken into consideration . This also applies to the variable factors influencing the willingness of the target population to take up and pursue preventive measures . In the planning of future studies equal weight should be placed on method ological rigour ( freedom from biases ) and transferability of results into routine care . Economic analyses require input of German data , either in form of a “ piggy back study “ or in form of a modelling study that reflects the structures of the German health care system and is based on German epidemiological and cost data Objectives : Depression and anxiety are commonly seen in patients with chronic pain which affects the patient ’s daily life functioning . Although considerable attention has been devoted to explain why depression and anxiety are frequent comorbid with chronic pain , little empirical work has been conducted on interventions that target depression and anxiety and chronic pain . The present study was design ed to test an individualized cognitive-behavioral treatment delivered through the internet for persons with chronic pain and emotional distress . Material s and Methods : A total of 52 patients with chronic pain and depression were included and r and omized to either treatment for 8 weeks or to a control group that participated in a moderated online discussion forum . Results : Intent-to-treat analyses showed significant decreases regarding depressive symptoms and pain disability in the treatment group . Results on the primary outcomes of depression and anxiety were in favor of the treatment group . Reductions were also found on pain catastrophizing . Discussion : One-year follow-up showed maintenance of improvements . We conclude that an individualized guided internet-delivered treatment based on cognitive-behavior therapy can be effective for persons with chronic pain comorbid emotional distress INTRODUCTION During the last 20 years a great number of studies have emphasized the potential role of psychological factors as relevant predictors for the first onset of back pain as well as for the development of chronic pain . The formulation of a biopsychosocial perspective of the etiology and chronicity of back pain was a natural consequence . Actual questions concern the relative impact of psychological risk factors in the process of chronicity of back pain compared to biomedical , social and occupational factors . METHODS Whereas several review articles regarding the role of psychological risk factors are available up to now , a recently published review conducted by Steven Linton was the first systematic analysis of well controlled prospect i ve studies published since 1967 . Using a grading system similar to that recommended for guidelines the author defined a level A evidence when at least two good- quality prospect i ve studies supported the prospect i ve power of a variable . Level B evidence had support from one prospect i ve study . Level C represented inconclusive data and level D indicated that no studies met the criteria . Based on a literature search of more than 900 studies , 37 good- quality prospect i ve studies were analysed in detail . RESULTS The results indicated level A evidence for the following interrelations : ( 1 ) Psychosocial variables , especially chronic distress in daily life , depression and work dissatisfaction were clearly associated with the onset of back and neck pain ( 2 ) . Psychological variables , especially chronic stress in daily life , work dissatisfaction , depression and pain-related cognitions and coping behaviour were clearly linked to the transition from acute to chronic pain and disability ( 3 ) . Psychological variables generally had more prospect i ve power than biomedical , social or objective occupational variables . Among the pain-related cognitions , catastrophizing and fear-avoidance-beliefs yielded the most empirical support . Among coping behaviour passive coping stretegies such as avoiding behaviour was most important . At least level B evidence has been shown for the counterpart of an extreme suppressive coping behaviour . Patients who tended to suppress or ignore pain in order to finish all activities they started , who were unable to integrate phases of passive relaxation into the daily routine displayed a high risk of chronicity of pain 6 months after an acute phase of pain . One international and two German good- quality prospect i ve studies have shown the predictive power of a maladaptive suppressive behaviour pattern . Based on the avoidance-endurance-model of pain chronification , both extreme and one-sided passive pain coping as well as one-sided suppressive coping modes were conceptualized as maladaptive due to the process of chronicity . We assume that extreme passive behaviour will lead to immobility and muscular atrophy . Neurophysiological processes of sensitization will further lead to the development of chronic pain . On the other h and , extreme suppressive behaviour will lead to an overuse of muscles and joints with a repetitive combination of muscular hyperactivity and pain . These repetitive pain experiences will also elicit neurophysiological processes of sensitization . ( 4 ) Psychosocial variables displayed more predictive power than biomedical or biomechanical factors . ( 5 ) Psychosocial factors may be used as predictors of the risk for developing long-term pain and disability . Mixed empirical evidence has been shown for the role of personality factors ( level C evidence ) and no support has been found for the idea of a " pain prone " personality disorder or for the role of sexual and physical abuse . DISCUSSION 20 years of research , several qualitative review s and a recently published systematic review of 37 good- quality prospect i ve studies regarding the role of psychological , biomedical , social and objective occupational factors in the process of chronicity of back pain revealed that psychological factors are significantly related to the onset of back pain as well as to the development of chronic pain . Furthermore , the psychological factors displayed more predictive power than biomedical or biomechanical variables . As a consequence for clinical practice , these psychological risk factors have to be considered as " yellow flags " if a back pain problem wo n't respond to medical treatment for more than four weeks . As a further consequence , special risk factor - based psychosocial interventions should be offered in addition to the medical treatment to patients with high psychological risk factors for the development of chronic pain . The efficacy of such an interdisciplinary care in the very early phases of back pain in order to prevent chronicity of pain and disability has been published recently by our group Study Design . A prospect i ve cohort study was conducted on workers cl aim ing earnings-related compensation for low back pain . Information obtained at the time of the initial cl aim was linked to compensation status ( still cl aim ing or not cl aim ing ) 3 months later . Objective . To identify individual , psychosocial , and workplace risk factors associated with the transition from acute to chronic occupational back pain . Summary of Background Data . Despite the magnitude of the economic and social costs associated with chronic occupational back pain , few prospect i ve studies have investigated risk factors identifiable in the acute stage . Methods . At the time of the initial compensation cl aim , a self-administered question naire was used to gather information on a wide range of risk factors . Then 3 months later , chronicity was determined from cl aim ants ’ computerized records . Results . The findings showed that 3 months after the initial assessment , 204 of the recruited 854 cl aim ants ( 23.9 % ) still were receiving compensation payments . A combined multiple regression model of individual , psychosocial , and workplace risk factors demonstrated that severe leg pain ( odds ratio [ OR ] , 1.9 ) , obesity ( OR , 1.7 ) , all three Oswestry Disability Index categories above minimal disability ( OR , 3.1–4 ) , a General Health Question naire score of at least 6 ( OR , 1.9 ) , unavailability of light duties on return to work ( OR , 1.7 ) , and a job requirement of lifting for three fourths of the day or more all were significant , independent determinants of chronicity ( P < 0.05 ) . Conclusions . Simple self-report measures of individual , psychosocial , and workplace factors administered when earnings-related compensation for back pain is cl aim ed initially can identify individuals with increased odds for development of chronic occupational disability ABSTRACT Background : The semi-synthetic opioid , buprenorphine , has the general structure of morphine but differs from it in significant ways , both pharmacologically and clinical ly . A number of long-term studies have shown effective , long-lasting analgesia in moderate to severe cancer and non-cancer pain , including neuropathic pain , with a low incidence of constipation , nausea , dizziness and tiredness . The treatment of moderate to severe chronic pain has improved as a result of the development of new methods of administration of this substance , particularly the introduction of the transdermal drug delivery system , which offers a number of advantages over the usual oral and parenteral routes . Scope : A panel of experts specialising in palliative care and pain treatment was convened in November 2007 to discuss their clinical experiences with transdermal buprenorphine and other analgesics . The aim was to provide practical guidance on the treatment of cancer pain with transdermal buprenorphine , particularly when there is a need for increasing pain relief leading to high and increasing doses . A literature search on the use of transdermal buprenorphine was carried out for the panel meeting ( based on a search of PubMed to November 2007 – since up date d by an additional search for the period to February 2009 ) and a number of case histories were presented and discussed . This commentary article presents this evidence and the consensus findings of the expert panel . Findings : The Panel reached consensus that transdermal buprenorphine was a valuable treatment for chronic cancer pain , including its neuropathic components . A number of general recommendations were made . Large-scale , r and omised clinical studies are needed to provide product comparisons on the use of analgesics in the treatment of neuropathic pain although it was recognised that such studies may not be practicable . Data on the treatment of acute and chronic pain should be kept separate in general . Physicians should be made more aware of the problem of hyperalgesic effects of some opioids in long term use . Buprenorphine in contrast has been described to exert an antihyperalgesic effect . The development of analgesic tolerance with some opioids in long term use and the lack of it with buprenorphine requires further studies . The registered dose range of 35–140 µg/h was considered adequate to achieve sufficient pain relief in most patients although some members of the panel presented data showing that increases beyond this dose range provided improved pain relief if slow titration is used . However , it was generally felt that more evidence was needed before this could become generally acceptable . Conclusion : The consensus was that transdermal buprenorphine has a valuable role to play in the treatment of chronic cancer pain because of its efficacy and good safety and tolerability profile , including a low risk of respiratory depression , a lack of immunosuppression and a lack of accumulation in patients with impaired renal function Background Evidence indicates that supervised home exercises , combined or not with manual therapy , can be beneficial for patients with non-specific chronic neck pain ( NCNP ) . The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy ( SMT ) compared to a no treatment group in NCNP patients . Another objective is to assess the efficacy of SMT with and without a home exercise program . Methods Ninety-eight patients underwent a short symptomatic phase of treatment before being r and omly allocated to either an attention-group ( n = 29 ) , a SMT group ( n = 36 ) or a SMT + exercise group ( n = 33 ) . The preventive phase of treatment , which lasted for 10 months , consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms ( attention-control group ) , 1 monthly SMT session ( SMT group ) or 1 monthly SMT session combined with a home exercise program ( SMT + exercise group ) . The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale ( VAS ) , active cervical ranges of motion ( cROM ) , the neck disability index ( NDI ) and the Bournemouth question naire ( BQ ) . Exploratory outcome measures were scored on the Fear-avoidance Behaviour Question naire ( FABQ ) and the SF-12 Question naire . Results Our results show that , in the preventive phase of the trial , all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-r and omised , symptomatic phase . No group difference was observed for the primary , secondary and exploratory variables . Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial . However , no significant change in health related quality of life ( HRQL ) was associated with the preventive phase . Conclusions This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the preventive phase of the trial . This hypothesis was not supported by the study results . Lack of a treatment specific effect is discussed in relation to the placebo and patient provider interactions in manual therapies . Further research is needed to delineate the specific and non-specific effects of treatment modalities to prevent unnecessary disability and to minimise morbidity related to NCNP . Additional investigation is also required to identify the best strategies for secondary and tertiary prevention of NCNP.Trial registration Clinical Trials.gov : Post-herpetic neuralgia ( PHN ) following acute herpes zoster remains a significant cause of neuropathic pain especially in the elderly . Early treatment of the zoster rash with antiviral agents , such as aciclovir remains one of the few measures proven to reduce the incidence and duration of PHN albeit only in a subset of patients . It is therefore crucial that the physician who first sees a case of zoster identifies those patients who are most likely to develop long-term pain and treats them accordingly . In particular , prodrugs such as famciclovir and valaciclvoir may be more beneficial in reducing PHN than the shorter acting aciclovir , but can be more expensive . Measures that could be used to predict patients likely to develop PHN would also facilitate the evaluation of early use of antiepileptic , anti-inflammatory and analgesic agents in the prevention of PHN . In a prospect i ve study of 280 herpes zoster ( HZ ) cases seen by the general practitioner ( GP ) we evaluated the predictive value of five clinical factors identified in clinical trials as associated with a higher likelihood of PHN . A visual analogue score ( VAS ) over 5 and /or age over 50 correctly identified all subjects with PHN at 3 and 6 months , respectively . However , the specificity of this prediction was low because as many as 81 % and 85 % of those aged over 50 recovered within 3 and 6 months , respectively . Better methods are needed to identify patients over 50 at most risk of PHN that enable GPs to better allocate their re sources with respect to HZ treatment Introduction : Type 2 diabetes mellitus ( T2DM ) is a major health issue in New Zeal and Māori . Clinical trials have demonstrated potential for the prevention of T2DM , but whether community public health programmes aim ing to prevent diabetes are effective is untested . Objective : To describe the planning and design of an intervention aim ing to translate T2DM prevention clinical trial evidence into a community-wide population health intervention in a high risk predominantly Māori community . Approach : Community concerns about the diabetes burden were heard by the local diabetes nurse , herself a tribal member , and discussed with a locally raised academic . Project planning ensued . The intervention and its evaluation were design ed using a participatory community development model . The planned intervention had three components : community-wide health promotion initiatives conveying healthy lifestyle messages , community education and monitoring for identified high-risk individuals and their extended families , and a structural strategy aim ed at adapting local environments to support lifestyle changes . The evaluation plan involved interrupted time series surveys coupled with formative and process evaluations rather than a r and omised control trial design . Discussion : Consulting communities , validating community concerns and prioritising cultural and ethical issues were key steps . Time spent developing good relationships amongst the health provider and academic research team members at the outset proved invaluable , as the team were united in addressing the project planning and implementation challenges , such as funding obstacles that arose because of our ethically and culturally appropriate non-r and omised control trial evaluation design . The pre-intervention survey demonstrated high rates of diabetes ( 13 % ) , insulin resistance ( 33 % ) and risk factors , and provided evidence for positive , as opposed to negative , lifestyle intervention messages . Conclusion : Community-wide lifestyle interventions have the potential to reduce rates of type 2 diabetes and other chronic diseases in high-risk communities , but require a high level of commitment from the health sector and buy-in from the community . Adequate commitment , leadership , planning and re sources are essential CHRONIC pain continues to be a major humanitarian and socioeconomic burden with slow progress in the development of new preventive and therapeutic options .  Persistent postsurgical pain ( PPP  ) is a well-known and common clinical entity with a reported incidence between 5 and 50 % of patients after various common operations . PPP has received increased interest during the past 10–15 yr . These patients can be studied before injury is inflicted , and thus , PPP provides a special opportunity to underst and pathogenic mechanisms for developing a chronic pain state or the transition from an acute to a chronic pain state . What have we learned from clinical trials regarding pathogenic mechanisms of PPP and the effects of preventive or therapeutic interventions ? Despite the increased attention to PPP , most studies have done little more than codify the striking frequency with which this problem occurs after many disparate types of surgery : from inguinal herniorrhaphy to thoracotomy to breast surgery . It is likely that the pathogenic mechanisms leading to PPP are multiple , and thus , more rigorous study design will be required to better underst and how the problem evolves and who is at greatest risk . Such careful study design has been the exception rather than the rule . What we do know is that those that seem to be most relevant are gender , psychosocial factors , preoperative pain at the site of surgery or in other body regions , the type of surgical trauma , nerve damage , acute postoperative pain and inflammatory responses , perioperative analgesia , type of disease , recurrence of malignancy , and adjuvant therapy . Several years ago , the International Association for the Study of Pain defined PPP as a persistent pain state that is apparent more than 2 months postoperatively that can not be explained by other causes ( recurrence of disease , inflammation , and others ) . Most of the available literature has followed the lead of this overly simplistic definition and is composed of reports with insufficient pain assessment and little information regarding its consequences . Too often , studies on PPP have been conducted using a single assessment , asking patients simply to report whether they have persistent pain at one point in time using only a simple yes or no answer . Future studies should include not only a detailed assessment of the location , characteristics , and evolution of painful symptoms and associated changes in neurologic function but also assessment s of the consequences of persistent pain on physical and social function . These studies must be performed on a procedure-specific basis because the type of surgery has different consequences on specific organ functions , and new assessment scales must be developed and vali date d for individual procedures . We have only limited information from vali date d procedure-specific scoring systems , the most comprehensive example being the post groin hernia surgery pain scale . Finally , previous classifications of PPP as neuropathic and nociceptive pain have lacked specific objective criteria for such subgroupings , leading to the artificial concept that these two types of pain can be easily teased apart — even more damaging is the concept that the treatment for these two interwoven pain syndromes somehow differs . Indeed , many patients with PPP report both sensory abnormalities and localized stimulus-evoked pain , suggesting that both abnormal nerve function and ongoing nociception play a role in PPP . Less than a h and ful of studies have included detailed neurophysiologic assessment of PPP . There is a dramatic need for similar procedure-specific studies that are conducted prospect ively to detail the evolution and characteristics of PPP and include pain-related functional impairment scales to assess the real impact of this problem . The pathogenic factors involved in PPP may be divided into patient and surgery-related factors , of which preoperative factors to be assessed in detail include psychosocial factors , pain and its consequences , nociceptive function , and gender . Of the intraoperative factors , type of anesthesia , surgical approach ( magnitude of tissue damage ) , nerve identification , and nerve injury are obviously important , and postoperative factors should include a detailed description of the type of analgesia , duration , early follow-up with neurophysiologic assessment s , disease data , and detailed assessment of pain and its functional consequences . Although 2 months postoperatively has been proposed as a criterion for PPP , the definition was not based on procedure-specific data , and after some operations , a continuous inflammatory response may be apparent calling for assessment s for at least 3–6 months postoperatively to provide useful information . Although these requirements for study design may seem obvious and easy to include in clinical trials , an example from a Accepted for publication November 17 , 2009 . The authors are not supported by , nor maintain any financial interest in , any commercial activity that may be associated with the topic of this article Study Design . R and omized , parallel-group trial . Objective . To compare the effect of 3 early intervention strategies following whiplash injury . Summary of Background Data . Long-lasting pain and disability , known as chronic whiplash-associated disorder ( WAD ) , may develop after a forced flexion-extension trauma to the cervical spine . It is unclear whether this , in some cases disabling , condition can be prevented by early intervention . Active interventions have been recommended but have not been compared with information only . Methods . Participants were recruited from emergency units and general practitioners within 10 days after a whiplash injury and r and omized to : 1 ) immobilization of the cervical spine in a rigid collar followed by active mobilization , 2 ) advice to “ act-as-usual , ” or 3 ) an active mobilization program ( Mechanical Diagnosis and Therapy ) . Follow-up was carried out after 3 , 6 , and 12 months postinjury . Treatment effect was measured in terms of headache and neck pain intensity ( 0–10 ) , disability , and work capability . Results . A total of 458 participants were included . At the 1-year follow-up , 48 % of participants reported considerable neck pain , 53 % disability , and 14 % were still sick listed at 1 year follow-up . No significant differences were observed between the 3 interventions group . Conclusion . Immobilization , “ act-as-usual , ” and mobilization had similar effects regarding prevention of pain , disability , and work capability 1 year after a whiplash injury OBJECTIVE Stroke survivors are at high risk of stroke recurrence yet current strategies to reduce recurrence risk are sub-optimal . The UK Medical Research Council ( MRC ) have proposed a framework for developing and evaluating complex interventions , such as community management of stroke secondary prevention . The Framework outlines a five-phased approach from theory through to implementation of effective interventions . This paper reports Phases I-III of the development of a novel intervention to improve risk factor management after stroke . METHODS The pre- clinical /theoretical phase entailed review ing the literature and undertaking quantitative and qualitative studies to identify current practice s and barriers to secondary prevention . In Phase I ( modelling ) , findings were used to design an intervention with the potential to overcome barriers to effective stroke secondary prevention management . The feasibility of delivering the intervention and its acceptability were tested in the Phase II exploratory trial involving 25 stroke survivors and their general practitioners . RESULTS This led to the development of the definitive risk factor management  intervention . This comprises multiple components and involves using an on-going population stroke register to target patients , carers and health care professionals with tailored secondary prevention advice . Clinical , socio-demographic and service use data collected by the stroke register are transformed to provide an individualised secondary prevention package for patients , carers and health care professionals at three time points : within 10 weeks , 3 and 6 months post-stroke . CONCLUSION The intervention is currently being evaluated in a r and omised controlled trial . Further research is needed to test generalisability to other aspects of stroke management and for other chronic diseases . PRACTICE IMPLICATION S The MRC Framework for complex interventions provides a structured approach to guide the development of novel interventions in public health . Implication s for practice in stroke secondary prevention will emerge when the results of our r and omised controlled trial are published & NA ; Using latent class analysis ( LCA ) , a previous study on patients attending primary care identified four courses of low back pain ( LBP ) over the subsequent 6 months . To date , no studies have used longitudinal pain recordings to examine the “ natural ” course of recurrent and chronic LBP in a population ‐based sample of individuals . This study examines the course of LBP in the general population and elaborates on the stability and criterion‐related validity of the clusters derived . A r and om sample of 400 individuals reporting LBP in a population ‐based study was asked to complete a comprehensive question naire at the start and end of the year 's survey , and 52 weekly pain diaries in between . The latter were analyzed using LCA . 305 individuals returned more than 50 % of the diaries . Four clusters were identified ( severe persistent , moderate persistent , mild persistent , and fluctuating ) . The clusters differed significantly with regards to pain and disability . Assessment of cluster stability showed that a considerable proportion of patients in the “ fluctuating ” group changed their classification over time . Three of the four clusters describing the typical course of pain matched the clusters described previously for patients in primary care . Due to the population ‐based design , this study achieves , for the first time , a close insight into the “ natural ” course of chronic and recurrent low back pain , including individuals that did not necessarily visit the general practitioner . The findings will help to underst and better the nature of this pain in the general population Summary Chronic postsurgical pain  was common after major surgery in the Evaluation of Nitrous Oxide in the Gas Mixture for Anaesthesia ( ENIGMA ) trial . Nitrous oxide administration was associated with a decrease in the risk of chronic wound pain after surgery . ABSTRACT Nitrous oxide is an antagonist at the N‐methyl‐D‐aspartate receptor and may prevent the development of chronic postsurgical pain . We conducted a follow‐up study in the Evaluation of Nitrous Oxide in the Gas Mixture for Anaesthesia ( ENIGMA ) trial patients to evaluate the preventive analgesic efficacy of nitrous oxide after major surgery . The ENIGMA trial was a r and omized controlled trial of nitrous oxide‐based or nitrous oxide‐free general anesthesia in patients presenting for noncardiac surgery lasting more than 2 hours . Using a structured telephone interview , we contacted all ENIGMA trial patients recruited in Hong Kong ( n = 640 ) . We recorded the severity of postsurgical pain of at least 3 months ’ duration that was not due to disease recurrence or a pre‐existing pain syndrome , using the modified Brief Pain Inventory . The impact of postsurgical pain on quality of life was also measured . Pain intensity , opioid and other analgesic requirements during the first week of surgery , were retrieved from the trial case report form and medical records . A total of 46 ( 10.9 % ) patients reported pain that persisted from the index surgery , and 39 ( 9.2 % ) patients had severe pain . In addition , patients with chronic pain rated poorly in all attributes of the quality ‐of‐life measures compared with those who were pain free . In a multivariate analysis , nitrous oxide decreased the risk of chronic postsurgical pain . In addition , severe pain in the first postoperative week , wound complication , and abdominal incision increased the risk of chronic pain . In conclusion , chronic postsurgical pain was common after major surgery in the ENIGMA trial . Intraoperative nitrous oxide administration was associated with a reduced risk of chronic postsurgical pain Background Low back pain ( LBP ) and neck pain ( NP ) are common among workers .  Participatory Ergonomics ( PE ) is used as an implementation strategy to prevent these symptoms . By following the steps of PE , working groups composed and prioritised ergonomic measures , and developed an implementation plan . Working group members were responsible to implement the ergonomic measures in their departments . Little is known about factors that hamper ( barriers ) or enhance ( facilitators ) the implementation of ergonomic measures . This study aim ed to identify and underst and the possible barriers and facilitators that were perceived during implementation . Methods This study is embedded in a cluster r and omised controlled trial that investigated the effectiveness of PE to prevent LBP and NP among workers . For the purpose of the current study , question naires were sent to 81 working group members . Their answers were used to make a first inventory of possible barriers and facilitators to implementation . Based on the question naire information , 15 semi-structured interviews were held to explore the barriers and facilitators in more detail . All interviews were audio taped , transcribed verbatim , and analysed according to a systematic approach . Results All possible barriers and facilitators were obtained from question naire data , indicating that the semi-structured interviews did not yield information about new factors . Various barriers and facilitators were experienced . The presence of implementation plans for ergonomic measures  that were already approved by the management facilitated implementation before the working group meeting . In these cases , PE served as a strategy to improve the implementation of the approved measures . Furthermore , the findings showed that the composition of a working group ( i.e. , including decision makers and a worker who led the implementation process ) was important . Moreover , stakeholder involvement and collaboration were reported to considerably improve implementation . Conclusions This study showed that the working group as well as stakeholder involvement and collaboration were important facilitating factors . Moreover , PE was used as a strategy to improve the implementation of existing ergonomic measures . The results can be used to improve PE programmes , and thereby may contribute to the prevention of LBP and NP.Trial registration numberIS RCT Summary A clinical prediction rule comprising relevant biopsychosocial factors was derived to predict both  chronic moderate/severe disability and full recovery following whiplash injury . Abstract Recovery following a whiplash injury is varied : approximately 50 % of individuals fully recover , 25 % develop persistent moderate/severe pain and disability , and 25 % experience milder levels of disability . Identification of individuals likely to develop moderate/severe disability or to fully recover may help direct therapeutic re sources and optimise treatment . A clinical prediction rule ( CPR ) is a research ‐generated tool used to predict outcomes such as likelihood of developing moderate/severe disability or experiencing full recovery from whiplash injury . The purpose of this study was to assess the plausibility of developing a CPR . Participants from 2 prospect i ve , longitudinal studies that examined prognostic factors for poor functional recovery following whiplash injury were used to derive this tool . Eight factors , previously identified as predictor variables of poor recovery , were included in the analyses : initial neck disability index ( NDI ) , initial neck pain ( visual analogue scale ) , cold pain threshold , range of neck movement , age , gender , presence of headache , and posttraumatic stress symptoms ( Posttraumatic Diagnostic Scale [ PDS ] ) . An increased probability of developing chronic moderate/severe disability was predicted in the presence of older age and initially higher levels of NDI and hyperarousal symptoms ( PDS ) ( positive predictive value [ PPV ] = 71 % ) . The probability of full recovery was increased in younger individuals with initially lower levels of neck disability ( PPV = 71 % ) . This study provides initial evidence for a CPR to predict both chronic moderate/severe disability and full recovery following a whiplash injury . Further research is needed to vali date the tool , determine the acceptability of the proposed CPR by practitioners , and assess the impact of inclusion in practice Study Design . A cross-sectional , descriptive vignette survey of practicing , musculoskeletal physical therapists . Objectives . The aim of this study was to determine if musculoskeletal physical therapists , in the United Kingdom , recognize when patients with low back pain ( LBP ) are at risk of chronicity due to psychosocial factors . A secondary aim was to explore the advice they give to patients about  work and activities .  Summary of Background Data . Psychosocial factors have been shown to be important in the progression from acute LBP to chronic disability . Early identification of individuals at risk of developing chronic disability is important to enable targeted intervention . Methods . Three vignettes were written based on acute LBP patients attending for physical therapy  and incorporated into a self-completed postal question naire sent to a simple r and om sample of musculoskeletal physical therapists in the United Kingdom ( n = 900 ) . After one reminder , 20 % of nonresponders were sent a further question naire ( n = 80 ) . Data were analyzed using the Statistical Package for the Social Sciences ( SPSS version 11 ) . Results . The response rate was 57.7 % ( n = 518 ) with 453 meeting all inclusion criteria . The sample consisted of physical therapists working in the musculoskeletal field across all practice setting s. Most correctly rated the chronicity risk of the low- and high-risk patient vignettes . Advice to restrict work and activity was common . Conclusions . Most physical therapists recognize when patients are at high risk of developing chronicity , yet many recommend the patient limit their activity levels and not work . Advice to “ not work ” is associated with more severe perceived spinal pathology , suggesting persistence of the biomedical model for LBP Abstract Although more severe acute postoperative pain increases the risk of chronic pain following breast cancer surgery , few studies have examined the characteristics of patients who develop greater acute pain . To identify risk factors for acute pain and its persistence one month following breast cancer surgery , a sample of 114 women scheduled for breast cancer surgery was assessed preoperatively for demographic , clinical , and emotional functioning variables that were hypothesized to be associated with acute pain severity . Clinical ly meaningful postoperative pain  was assessed at follow‐up interviews 2 , 10 , and 30 days after surgery . In univariate analyses , the risk of clinical ly meaningful acute pain was increased among women who were younger , unmarried , had more invasive surgeries , and had greater preoperative emotional distress . In multiple logistic regression analyses , greater preoperative anxiety was the only variable that made an independent contribution to predicting clinical ly meaningful acute pain at 2 days after surgery whereas younger age , being unmarried , and preoperative anxiety each made an independent contribution to predicting clinical ly meaningful acute pain that persisted from 2 to 30 days after surgery . These results increase underst and ing of neurobiologic mechanisms and psychosocial processes that contribute to the development of acute pain following breast cancer surgery and have implication s for the development of interventions to prevent it & NA ; This prospect i ve study identifies physical , behavioral , and psychosocial correlates of subsequent employment status in a sample of low back pain patients . The sample of 150 subjects was drawn from 2 population s of persons with chronic low back pain : 87 individuals who were receiving care at a university low back pain clinic , and 63 individuals who had applied for ( but not yet received ) Social Security compensation on the basis of low back pain . All subjects had worked at least 3 months prior to their latest unemployment period and were currently out of work . Initial assessment included a medical history , physical examination , biomechanical testing , psychiatric interview , and MMPI testing .  All subjects were followed up 6 months later to determine whether they had returned to work . Cross‐sectional group comparisons at the time of initial assessment showed that , after controlling for the effects of age , the two sample s differed on several physical and biomechanical measures , the Social Security group reflecting a more chronic picture . Group differences on physical variables were found , but most significant differences disappeared when adjusted for length of time out‐of‐work . Longitudinal analyses showed that few objective physical or biomechanical measures were associated with return‐to‐work at 6 months , while a number of psychosocial variables were significant predictors of 6‐month work status . The data suggest that exclusive reliance on the physical examination to determine level of disability , without consideration of psychosocial conditions , and without adjusting for the confounding effects of age and length of time out‐of‐work , is not empirically justified . Logistic regression analysis was used to ascertain the relative contribution of each predictor to outcome and to illustrate the hypothetical effects of changes in the levels of selected risk factors on the likelihood of return‐to‐work . Implication s for interventions with low back pain patients are discussed and future research directions suggested Objective : Recent recommendations suggest that reassuring patients with an acute bout of low back pain and encouraging a return to normal activities may be helpful in preventing the development of chronic disability . There is also a question as to whether psychologic or physical therapy interventions actually add anything to such reassurance and advice in terms of preventing chronicity . This study aim ed to ascertain the preventive effects on future sick leave and health-care utilization of adding on a cognitive-behavioral group intervention or a cognitive-behavioral group intervention and preventive physical therapy ( focused on activity and exercise ) relative to a minimal treatment group ( examination , reassurance , and activity advice ) . Subjects : A total of 185 patients seeking care for nonspecific back or neck pain who were employed and at risk for developing long-term disability volunteered to participate in the study . Of these 185 , 158 ( 85 % ) completed the pre- and 1-year follow-up assessment s. Results : Significant differences were observed on the key outcome variables of future health-care utilization and work absenteeism . For health-care utilization , the cognitive-behavioral intervention group and preventive physical therapy group had significantly fewer healthcare visits than did the Minimal Treatment Group . For work absenteeism , the cognitive-behavioral intervention group and cognitive-behavioral intervention and preventive physical therapy group had fewer days during the 12-month follow-up than did the Minimal Treatment Group . The risk for developing long-term sick disability leave was more than five-fold higher in the Minimal Group as compared with the other 2 groups . However , there was no difference between the cognitive-behavioral intervention group and cognitive-behavioral intervention and preventive physical therapy group on sick leave . Conclusion : Taken as a whole , this study shows that adding cognitive-behavioral intervention and cognitive-behavioral intervention and preventive physical therapy can enhance the prevention of long-term disability . There was no substantial difference in the results between the cognitive-behavioral intervention group and cognitive-behavioral intervention and preventive physical therapy group OBJECTIVE The objective of this study was to examine whether a multimodal , secondary prevention program ( MP ) is superior to a general physical exercise program ( EP ) in influencing the process leading to chronic low back pain ( LBP ) in nurses with a history of back pain . DESIGN The study was conducted as a r and omized controlled parallel-group trial . SETTING The interventions were performed in a single center at the Department of Physical and Rehabilitation Medicine at the University of Munich in Germany . PARTICIPANTS A total of 235 nurses from 14 nearby hospitals and nursing homes who experienced at least one episode of back pain during the previous 2 years were invited into the study . Of these , 183 nurses were enrolled and 169 ( 83 in the MP and 86 in the EP ) qualified for the intent-to-treat analysis . INTERVENTIONS The EP consisted of 11 group sessions , each lasting 1 hour . After introductory sessions , subsequent sessions included general physical strengthening and stretching exercises as well as instructions for a home-training program . The MP consisted of 17 group sessions of 1.75 hours and one individual session of 45 minutes . In addition to the full EP , the MP included 5 psychological units , 7 segmental stabilization exercises units , and 8 ergonomic and workplace-specific units . MAIN OUTCOME MEASUREMENTS The primary study end-point variable was pain interference , and the secondary study end-point variables were pain intensity and functioning as measured with the West Haven-Yale Multidimensional Pain Inventory and the Short Form-36 , respectively . These study end-point variables were defined a priori . RESULTS There was no statistically significant difference between the 2 groups . Small-to-moderate effects were observed in both intervention programs across all study end-point variables . For pain interference , the effect size at 12 months after intervention was 0.58 in the MP and 0.47 in the EP . CONCLUSIONS A multimodal program is not superior to a general exercise program in influencing the process leading to chronic LBP in a population of nurses with a history of pain . The most likely explanation is a common psychological mechanism leading to improved pain interference that is irrespective of the program used . Considering the lower re sources of the general exercise program , the expense for a multimodal program is not justified for the secondary prevention of LBP and disability Chronic musculoskeletal pain constitutes a large socioeconomic challenge , and preventive measures with documented effects are warranted . The authors ' aim in this study was to prospect ively investigate the association between physical exercise , body mass index ( BMI ) , and risk of chronic pain in the low back and neck/shoulders . The study comprised data on approximately 30,000 women and men in the Nord-Trøndelag Health Study ( Norway ) who reported no pain or physical impairment at baseline in 1984 - 1986 . Occurrence of  chronic musculoskeletal pain  was assessed at follow-up in 1995 - 1997 . A generalized linear model was used to calculate adjusted risk ratios . For both females and males , hours of physical exercise per week were linearly and inversely associated with risk of chronic pain in the low back ( women : P-trend = 0.02 ; men : P-trend < 0.001 ) and neck/shoulders ( women : P-trend = 0.002 ; men : P-trend < 0.001 ) . Obese women and men had an approximately 20 % increased risk of chronic pain in both the low back and the neck/shoulders . Exercising for 1 or more hours per week compensated , to some extent , for the adverse effect of high BMI on risk of chronic pain . The authors conclude that physical inactivity and high BMI are associated with an increased risk of chronic pain in the low back and neck/shoulders in the general adult population An intervention that can prevent low back pain ( LBP ) becoming chronic , may not only prevent great discomfort for patients , but also save substantial costs for the society . Psychosocial factors appear to be of importance in the transition of acute to chronic LBP . The aim of this study was to compare the cost-effectiveness of an intervention aim ed at psychosocial factors to usual care in patients with (sub)acute LBP . The study design was an economic evaluation alongside a cluster-r and omized controlled trial , conducted from a societal perspective with a follow-up of 1 year . Sixty general practitioners in 41 general practice s recruited 314 patients with non-specific LBP of less than 12 weeks ’ duration . General practitioners in the minimal intervention strategy ( MIS ) group explored and discussed psychosocial prognostic factors . Usual care ( UC ) was not protocol ized . Clinical outcomes were functional disability ( Rol and –Morris Disability Question naire ) , perceived recovery and health-related quality of life ( EuroQol ) . Cost data consisted of direct and indirect costs and were measured by patient cost diaries and general practitioner registration forms . Complete cost data were available for 80 % of the patients . Differences in clinical outcomes between both the groups were small and not statistically significant . Differences in cost data were in favor of MIS . However , the complete case analysis and the sensitivity analyses with imputed cost data were inconsistent with regard to the statistical significance of this difference in cost data . This study presents conflicting points of view regarding the cost-effectiveness of MIS . We conclude that ( Dutch ) general practitioners , as yet , should not replace their usual care by this new intervention AIMS AND OBJECTIVE The objective of this study was to identify prognostic factors associated with the development of pressure ulcer lesions ( grade 2 - 4 ) in nursing home patients with non-blanchable erythema . BACKGROUND No studies could be found that identify risk factors for further development of pressure ulcer in patients with non-blanchable erythema . For some patients with non-blanchable erythema , st and ard preventive measures do not suffice to prevent pressure ulcers from deterioration . Identifying these patients beforeh and can considerably contribute to the efficiency of pressure ulcer prevention . DESIGN Secondary data analyses of a previously conducted r and omised controlled trial were performed . METHODS Eighty-four wards of 16 Belgian nursing homes participated in the study . In total , 235 nursing home residents with a grade 1 pressure ulcer ( non-blanchable erythema ) were included . All the residents received st and ard preventive care . Potential prognostic factors were collected using a st and ardised form . The incidence of pressure ulcers was recorded according to the European pressure ulcer classification system . RESULTS The cumulative pressure ulcer incidence was 18.7 % ( 44/235 ) . Hypotension ( relative risk = 3.42 , 95 % CI = 1.56 - 7.49 ) , a history of a cerebral vascular accident ( relative risk = 1.94 , 95 % CI = 1.10 - 3.70 ) and contractures ( relative risk = 2.02 , 95 % CI 1.03 - 3.95 ) were identified as independent predictive factors for developing pressure ulcers . Remarkably , being urinary incontinent decreased the risk of developing a pressure ulcer by 76 % . CONCLUSIONS In nursing home residents with non-blanchable erythema , hypotension , contractures , and a history of cerebral vascular accident were independent risk factors for the development of pressure ulcer lesions . RELEVANCE TO CLINICAL PRACTICE Patients with non-blanchable erythema who have hypotension , contractures or a history of cerebral vascular accident are in need of more intensive preventive measures . Identifying these patients can contribute considerably to a more efficient pressure ulcer prevention policy , result ing in a lower pressure ulcer lesion incidence and in lower costs Background : Women scheduled to undergo hysterectomy for benign indications frequently have preoperative pelvic pain , but it is largely unknown why pain in some cases persists or even develops after surgery . This nationwide question naire and data base study describes pain and identifies risk factors for chronic  postsurgical pain  1 yr after hysterectomy for benign indications . Methods : A pain question naire was mailed to 1,299 women 1 yr after hysterectomy .  The response rate was 90.3 % , and the presence of persistent pain was correlated to indication for surgery , surgical procedure , type of anesthesia , and other perioperative data . Results : Pain was reported by 31.9 % 1 yr after hysterectomy ( chronic pain ) , and 13.7 % had pain more than 2 days a week . Pain was not present before surgery in 14.9 % of women with chronic postsurgical pain . Risk factors for chronic pain were preoperative pelvic pain ( odds ratio [ OR ] , 3.25 ; 95 % confidence interval [ CI ] , 2.40–4.41 ) , previous cesarean delivery ( OR , 1.54 ; CI , 1.06–2.26 ) , pain as the main indication for surgery ( OR , 2.98 ; CI , 1.54–5.77 ) , and pain problems elsewhere ( OR , 3.19 ; CI , 2.29–4.44 ) . Vaginal hysterectomy versus total abdominal hysterectomy was not significantly associated with a lower risk of chronic pain ( OR , 0.70 ; CI , 0.46–1.06 ) . Importantly , spinal versus general anesthesia was associated with less chronic pain ( OR , 0.42 ; CI , 0.21–0.85 ) . Conclusions : Thirty-two percent had chronic pain after hysterectomy , and risk factors were comparable to those seen in other operations . Interestingly , spinal anesthesia was associated with a lower frequency of chronic pain , justifying prospect i ve study of spinal anesthesia for patients with a high risk for development of chronic postsurgical pain This study investigated the incidence and risk factors associated with  chronic pain after elective caesarean section under spinal anaesthesia in an Asian population . A prospect i ve cohort study was conducted among subjects who underwent elective caesarean section under spinal anaesthesia  , with morphine patient-controlled analgesia administered for 24 hours postoperatively . Perioperative , surgical and obstetric factors were investigated prospect ively . Phone surveys were conducted to identify risk factors associated with chronic pain . A total of 857 subjects completed both the perioperative study and phone survey . The incidence of wound scar pain for three months after surgery was 9.2 % ( 79 ) . Of the 51 subjects with persistent pain at the time of subsequent survey , 9.8 % ( n=5 ) had constant pain , 9.8 % ( n=5 ) had daily pain and 23.5 % ( n=12 ) had pain intermittently , at an interval of days . The independent risk factors for development of chronic pain were higher pain scores recalled in the immediate postoperative period ( odds ratio [ OR , 95 % confidence interval ] 1.348 [ 1.219 to 1.490 ] , P=0.0001 ) , pain present elsewhere ( OR 2.471 [ 1.485 to 4.112 ] , P=0.001 ) and non-private insurance status ( OR 1.679 [ 1.034 to 2.727 ] , P=0.036 ) . The two most common sites of pain other than wound pain were back pain ( n=316 ) and migraine ( n=87 ) Background Whiplash-associated disorder ( or " whiplash " ) is a common condition incurring considerable expense in social and economic terms . A lack of research on effective therapy for patients with chronic whiplash associated disorders prompted the design of the current study . The primary aim of this r and omised controlled trial is to determine the effects of a physical activity program for people with chronic ( symptoms of > 3 months duration ) whiplash .  A secondary aim is to determine if pain severity , level of disability and fear of movement/(re)injury predict response to a physical activity program . Methods / Design This paper presents the rationale and design of a r and omised controlled trial examining the effects of advice and individualized sub-maximal exercise programs  in the treatment of whiplash associated disorders . Discussion This paper highlights the design , methods and operational aspects of a significant clinical trial in the area of whiplash and chronic pain This is the second of two papers which describes a research project which was design ed to evaluate the use of Snoezelen for the management of chronic pain .  Part I explored the concepts underpinning both chronic pain and the Snoezelen itself which subsequently result ed in the development of an appropriate study design . The purpose of the study was to compare the use of Snoezelen for the management of chronic pain  as a potential relaxation and distraction strategy , compared to the traditional relaxation approach used within the clinic . This paper will present the results that were obtained with the research project and in the light of these findings the author will discuss implication s for future investigation and practice There is growing evidence for the idea that in back pain patients , pain-related fear ( fear of pain/physical activity/(re)injury ) may be more disabling than pain itself . A number of question naires have been developed to quantify pain-related fears , including the Fear-Avoidance Beliefs Question naire ( FABQ ) , the Tampa Scale for Kinesiophobia ( TSK ) , and the Pain Anxiety Symptoms Scale ( PASS ) . A total of 104 patients , presenting to a rehabilitation center or a comprehensive pain clinic with chronic low back pain were studied in three independent studies aim ed at ( 1 ) replicating that pain-related fear is more disabling than pain itself ( 2 ) investigating the association between pain-related fear and poor behavioral performance and ( 3 ) investigating whether pain-related fear measures are better predictors of disability and behavioral performance than measures of general negative affect or general negative pain beliefs ( e.g. pain catastrophizing ) . All three studies showed similar results . Highest correlations were found among the pain-related fear measures and measures of self-reported disability and behavioral performance . Even when controlling for sociodemographics , multiple regression analyses revealed that the subscales of the FABQ and the TSK were superior in predicting self-reported disability and poor behavioral performance . The PASS appeared more strongly associated with pain catastrophizing and negative affect , and was less predictive of pain disability and behavioral performance . Implication s for chronic back pain assessment , prevention and treatment are discussed Chronic pain can be devastating , it impinges upon the life of the sufferer , causing psychological , physical , social and financial problems , leaving the individual search ing for an explanation and a cure . Although there are no major epidemiological studies to date , it has been suggested that the impact of chronic pain , not only to the patient , but also to society and the NHS is phenomenal , with loss of production and costs of treatments ( Fordyce 1995 ) . Specialists within the field of chronic pain have advocated the use of the multidisciplinary approach to deal with the problems and thus suggest the use of the pain management programme , which is design ed to teach the patient coping strategies . Recently , however , there has been a call within the literature to identify the effectiveness of singular strategies , which may be equally as effective and less expensive ( Keefe et al 1992 ) . The purpose of these papers is to introduce one such strategy , which has been evaluated over the past four years in order to investigate the use of the sensory environment ( Snoezelen )  for the management of chronic pain . In part II of this paper , an evaluation of Snoezelen and chronic pain will be presented , along with the findings of an investigation into its use A multicentre r and omised controlled trial has been commissioned to evaluate cognitive-behavioural ( CB ) approaches in the management of  subacute and chronic low back pain in primary care . This paper describes the development of the CB intervention based on best-available evidence . Several methods were used to design the intervention . Risk factors for the development of chronic low back pain were identified from the literature to provide targets for treatment , essential components of a CB intervention were considered using the CB treatment model , and the optimal delivery method was used to balance clinical effectiveness and cost-effectiveness within primary care Undernutrition may be an important modifiable risk factor for poor clinical outcomes in older individuals . To achieve earlier detection or prevention of undernutrition , more information is needed about risk factors for the development of undernutrition in community-dwelling older individuals . The objective was to identify early determinants of incident undernutrition in a prospect i ve population -based study . Baseline data ( 1992 - 3 ) on socio-economic , psychological , medical , functional , lifestyle and social factors of 1120 participants aged 65 - 85 years of the Longitudinal Aging Study Amsterdam were used . Undernutrition , defined as a BMI < 20 kg/m2 or self-reported involuntary weight loss ≥ 5 % in the last 6 months , was assessed every 3 years during a 9-year follow-up period . Cox proportional-hazards regression analysis was used to investigate the association between early determinants at baseline and incident undernutrition . In 9 years , 156 participants ( 13·9 % ) developed undernutrition . In univariate analyses , female sex , depressive symptoms , anxiety symptoms , multiple chronic diseases , high medication use ( women ) , poor appetite , no alcohol use v. light alcohol use , loneliness , not having a partner , limitations in performing normal activities due to a health problem , low physical performance ( participants aged < 75 years ) and reporting difficulties walking stairs ( participants aged < 75 years ) were statistically significantly associated with incident undernutrition . In a multivariate model , poor appetite and reporting difficulties walking stairs ( participants aged < 75 years ) remained early determinants . The results of the present study can be used to identify subgroups of older individuals with increased risk of undernutrition and to identify modifiable determinants for the purpose of prevention of undernutrition Summary An intricate relationship between chronic pain , opioid use and addictive behaviors was demonstrated , and certain addictive behaviors seem to predict or be associated with opioid use in chronic non‐cancer pain . Abstract The growing body of research showing increased opioid use in patients with chronic pain coupled with concerns regarding addiction encouraged the development of this population ‐based study . The goal of the study was to investigate the co‐occurrence of indicators of addictive behaviors in patients with chronic non‐cancer pain in long‐term opioid treatment . The study combined data from the  individual‐based Danish Health Survey in 2010 and the official Danish health and socio‐economic , individual‐based registers . From a simple r and om sample of 25,000 adults ( 16 years or older ) living in Denmark , 13,281 individuals were analyzed through multiple logistic regression analyses to assess the association between chronic pain ( lasting ≥6 months ) , opioid use , health behavior , and body mass index . Six potential addictive behaviors were identified : daily smoking ; high alcohol intake ; illicit drug use in the past year ; obesity ; long‐term use of benzodiazepines ; and long‐term use of benzodiazepine‐related drugs . At least 2 of the 6 addictive behaviors were observed in 22.6 % of the long‐term opioid users with chronic pain compared with 11.5 % of the non‐opioid users with chronic pain and 8.9 % of the individuals without chronic pain . Thus , a strong association was demonstrated between long‐term opioid use and the clustering of addictive behaviors . An intricate relationship between chronic pain , opioid use , and addictive behaviors was observed in this study , which deserves both clinical attention and further research OBJECTIVES Opiates are commonly used to treat patients with chronic nonmalignant pain . There is much controversy over the definition , incidence , and risk factors of prescription opiate abuse in chronic pain treatment . The present study , done at the Seattle VA Medical Center , was design ed to create opiate abuse criteria , test inter-rater reliability of the criteria , apply the criteria to a group of chronic pain patients , and correlate the risk of opiate abuse with the results of alcohol and drug testing . DESIGN / OUTCOME MEASURES A committee of experienced pain providers design ed a five-point prescription opiate abuse checklist based on DSM-III-R parameters . The criteria were then applied to patients enrolled in the pain clinic . The reliability of the criteria were determined using two providers who were familiar with every patient in the clinic . Drug , alcohol , and psychosocial testing were correlated with the risk of opiate abuse . RESULTS A total of 19 % ( 76/403 ) of all pain clinic patients were using chronic opiates . Thirty-four percent ( 26/76 ) met one , and 27.6 % ( 21/76 ) met three or more of the abuse criteria . The criteria had an inter-rater reliability of > 0.9 . There were no differences between chronic opiate users ( n = 76 ) and opiate abusers ( n = 21 ) for a history of drug or alcohol abuse or on psychosocial testing . CONCLUSIONS Prescription opiate abuse criteria for use in patients with chronic nonmalignant pain were design ed . The criteria had good reliability and can be applied during normal clinic interactions . The percentage of chronic opiate users who become opiate abusers in pain treatment is within the range reported by others . Past opiate or alcohol abuse or psychosocial testing on clinic admission failed to predict who would become an opiate abuser . The criteria can be used to identify patients who will subsequently require more intensive treatment or intervention or can be used as an outcome to measure to test the effectiveness of treatment strategies Objectives : To identify risk factors for postherpetic neuralgia ( PHN ) using a vali date d definition of this chronic neuropathic pain syndrome , to determine combinations of risk factors that identify patients with a high risk of developing PHN , and to examine the characteristics of patients with subacute herpetic neuralgia , that is , pain that persists beyond the acute phase of herpes zoster but that resolves before PHN can be diagnosed . Methods : The authors examined baseline and follow-up data from 965 herpes zoster patients enrolled within 72 hours of rash onset in two clinical trials of famciclovir .  Results : Univariate and multivariate analyses indicated that older age , female sex , presence of a prodrome , greater rash severity , and greater acute pain severity made independent contributions to identifying which patients developed PHN . Patients with subacute herpetic neuralgia who did not develop PHN were significantly younger and had less severe acute pain than PHN patients but were significantly more likely to have severe and widespread rash than patients without persisting pain . Conclusions : The independent contributions to the prediction of PHN made by older age , female sex , presence of a prodrome , greater rash severity , and greater acute pain severity suggest that these risk factors reflect different mechanisms that each contribute to the development of PHN . Subacute herpetic neuralgia that does not progress to PHN may reflect peripheral tissue damage and inflammation caused by a particularly severe or widespread rash BACKGROUND Women diagnosed with gestational diabetes mellitus ( GDM ) are at substantially increased risk of developing type 2 diabetes and obesity , currently at epidemic rates in the United States . GDM , therefore , identifies a population of women at high risk of developing type 2 diabetes and provides an opportunity to intervene before the development of this disorder . It is well recognized that acute as well as chronic physical activity improves glucose tolerance in type 2 diabetes . To date , however , primary prevention trials have not been conducted to test whether an increase in physical activity reduces risk of developing GDM among women at high risk of this disorder . METHODS The aims of this study are to investigate the effects of a motivationally targeted , individually tailored 12-week physical activity intervention on ( 1 ) development of GDM , ( 2 ) serum biomarkers associated with insulin resistance , and ( 3 ) the adoption and maintenance of exercise during pregnancy .  Women at high risk of GDM are recruited in early pregnancy and r and omized to either an individually tailored exercise intervention or a comparison health and wellness intervention . RESULTS The overall goal of the exercise intervention is to encourage pregnant women to achieve the American College of Obstetricians and Gynecologists guidelines for physical activity during pregnancy through increasing walking and developing a more active lifestyle . CONCLUSIONS The intervention takes into account the specific social , cultural , economic , and physical environmental challenges faced by pregnant women of diverse socioeconomic and ethnic background Background Previous studies have shown that electroacupuncture ( EA ) has a significant effect on acute pain , but it has not solved the clinical problem of the chronification of acute pain . Diffuse noxious inhibitory controls ( DNIC ) function as a reliable indicator to predict the risk of chronic pain events . DNIC function in knee osteoarthritis ( KOA ) patients has been demonstrated to gradually decrease during the development of chronic pain . The purpose of this study is to conduct a r and omized , controlled clinical trial to determine if EA can repair impaired DNIC function and thus prevent chronification of the acute pain of KOA . Methods / Design This is a multicenter , single blind , r and omized , controlled , three-arm , large-scale clinical trial . A total of 450 KOA patients will be r and omly assigned to three groups . The strong EA group will receive EA with high-intensity current ( 2 mA < current < 5 mA ) at the ipsilateral ‘ Neixiyan ’ ( EX-LE5 ) , ‘ Dubi’(ST35 ) , ‘ Liangqiu’(ST34 ) and ‘ Xuehai ’ ( SP10 ) . The weak EA group will receive EA with low-intensity current ( 0 mA < current < 0.5 mA ) on the same acupoints . The sham EA group will receive EA with low-intensity current ( 0 mA < current < 0.5 mA ) with fine needles inserted superficially into the sites 2 cm lateral to the above acupoints . The patients will be treated with EA once a day , 30 minutes per session , in 5 sessions per week , for 2 weeks . In order to determine the best stage of KOA for effective EA intervention , patients within the treatment groups also will be divided into four stages . The primary outcomes are Visual Analog Scale ( VAS ) , DNIC function and the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Clinical assessment s will be evaluated at baseline ( before treatment ) and after 5 to 10 sessions of treatment . Discussion This trial will be helpful in identifying whether strong EA is more effective than weak EA in reversing chronification of acute pain through repairing the impaired DNIC function and in screening for the best stage of KOA for effective EA intervention . Trial registration Chinese Clinical Trial Registry Number : ChiCTR-ICR-14005411 . The date of registration is 31 October 2014 Background Unhealthy nutrition and lifestyle contribute to the worldwide rising prevalence of non-communicable diseases . This also accounts for the reproductive population , in which unhealthy behavior affects fertility and pregnancy outcome . Maternal smoking , alcohol consumption and inadequate folic acid supplement use are strongly associated with fetal complications as small for gestational age , premature birth and congenital malformations . In the Netherl and s 83 % of the perinatal mortality rate is due to these complications and is relatively high compared to other European countries . In order to reduce this prevalence rate , preconception care should be focused on the promotion of health of prospect i ve parents by identification and intervention on modifiable nutrition and lifestyle risk factors . We developed the personal mHealth program ‘ Smarter Pregnancy ’ ( Dutch version available on : https://www.slimmerzwanger.nl ) to provide individual coaching and information to improve nutrition and lifestyle during the preconception period in order to improve health of the reproductive population and subsequent generations . Methods Women between 18 and 45 years of age , and trying to conceive are eligible for inclusion in a r and omized controlled trial . Participants are allocated either to a general population cohort or a subfertile ( IVF/ICSI ) population cohort . The intervention group receives personal online coaching based on the identified nutrition and lifestyle risk factors at baseline . Coaching comprises recipes , incentives , additional questions including feedback and text and e-mail messages , with a maximum of three per week . The control group only receives one recipe per week to maintain adherence to the program and prevent drop out . Screening question naires are send in both groups at 6 , 12 , 18 , and 24 weeks of the program to monitor the change in the identified risk factors . Discussion We expect to demonstrate that the mHealth program ‘ Smarter Pregnancy ’ can effectively improve nutrition and lifestyle in couples contemplating pregnancy . By the identification and improvement of modifiable nutrition and lifestyle risk factors on a large scale , both reproductive and pregnancy outcomes can be improved and subsequent perinatal morbidity and mortality rates are expected to be reduced . The current use and rapid development of mHealth applications offers new opportunities to reach and educate large population s , which can facilitate the implementation of preconception care . Trial registration Dutch trial register : NTR4150 . ( Registered 19th August 2013 With the emerging global focus on early psychosis , indicated prevention in schizophrenia has increasingly become a focus of psychiatric research interests . It has been argued that CBT may have some advantages compared with antipsychotics regarding this issue . According to MEDLINE , EMBASE and Psycinfo two completed r and omised controlled trials ( RCTs ; PACE , Melbourne , Australia ; EDIE , Manchester , United Kingdom ) and one ongoing RCT with only preliminary results published so far ( FETZ , Cologne/Bonn , Germany ) on indicated prevention in schizophrenia including manualised and st and ardised psychological treatment can be identified . The aims of the present paper are to present and discuss the three approaches with regard to ( I ) inclusion , exclusion and exit criteria , ( II ) characteristics of interventions and ( III ) evaluations . All interventions use intake , exclusion and exit criteria , which have been evaluated in prospect i ve follow-along studies . The approaches are based on the general structure and principles of cognitive behavioural therapy which have been developed , applied and evaluated in a wide range of mental health problems . Despite several method ological limitations , the first evaluations indicate some effects with regard to three possible aims of early intervention : ( 1 ) improvement of present possible pre-psychotic symptoms , ( 2 ) prevention of social decline/stagnation and ( 3 ) prevention or delay of progression to psychosis . Even though the first results are promising , we conclude that several ethical issues have to be taken into consideration and further predictive and therapeutic research is needed to judge whether psychological intervention is a realistic option for the treatment of people at risk of psychosis BACKGROUND Data have consistently shown that patient coping with chronic pain can be affected by various factors associated with the primary relationship , and hence efforts to include the patient 's partner in the treatment process have merit . This study evaluated the benefit of adding an adjunctive , couples-based , cognitive behavioural treatment ( CBT ) for chronic pain to a st and ard cognitive behavioural pain management programme . METHODS Forty-five couples were r and omly assigned to either an adjunctive couples intervention  ( n = 19 ) or the pain programme only ( n = 26 ) . All patient participants completed a 3-week multi-disciplinary pain management programme , to which their partners were invited to attend one full day . In addition , partners in the adjunctive condition received four , one hour treatment sessions focusing on pain education , patient-partner communication , operant behavioural principles and relapse prevention strategies . Partner sessions for the adjunctive intervention were provided over the telephone . RESULTS By the completion of the pain programme the adjunctive couples intervention demonstrated significant improvements in marital satisfaction for the spouses over and above attendance at the pain management programme alone ( p = 0.003 ) . However , spouse involvement did not facilitate any additional response to treatment for pain patients on marital satisfaction , pain , disability or any indices of distress . All treatment gains were maintained at 1 month follow-up . CONCLUSIONS These data demonstrate that a brief CBT intervention can significantly improve marital satisfaction for spouses of chronic pain patients , but the treatment does not translate to improvements in function on any outcomes , including marital satisfaction , for patients of chronic pain . WHAT DOES THIS STUDY ADD ? : A brief , telephone-based intervention for couples living with chronic pain is an acceptable format for intervention . This intervention can significantly improve marital satisfaction for partners of chronic pain patients . Patients who are already participating in a multidisciplinary pain programme will not obtain further benefit Although patients with chronic pain are often psychologically distressed , it has been difficult to determine whether this distress is an antecedent of chronic pain or whether it is caused by the experience of living with chronic pain . The aim of this investigation was to develop a method that would allow individuals who are at risk for the development of chronic pain to be studied before their pain has become chronic . Patients with acute herpes zoster were assessed with demographic , medical , pain , and psychosocial measures . Pain  was assessed in follow-up interviews at 6 weeks and 3 , 5 , 8 , and 12 months after these initial assessment s. There were no significant differences between patients who developed short-term herpes zoster pain and patients who did not develop short-term pain for any of the measures at the initial assessment , except for one measure of pain intensity . Patients who developed chronic herpes zoster pain , however , had significantly greater pain intensity , higher state and trait anxiety , greater depression , lower life satisfaction , and greater disease conviction at the initial assessment than patients who did not develop chronic pain . In discriminant analyses , disease conviction , pain intensity , and state anxiety each made a unique contribution to discriminating patients who did and who did not develop chronic pain .  This study demonstrates the feasibility of investigating psychosocial antecedents of the development of chronic pain by prospect ively examining the longitudinal course of herpes zoster Background Gestational diabetes mellitus ( GDM ) is a risk factor for the development of type 2 diabetes . Lifestyle intervention can prevent progression to type 2 diabetes in high risk population s. We design ed a r and omised controlled trial ( RCT ) to evaluate the effectiveness of an established lifestyle intervention compared to st and ard care for delaying diabetes onset in European women with recent GDM . Recruitment into the RCT was more challenging than anticipated with only 89 of 410 ( 22 % ) women agreeing to participate . This paper identifies factors that could enhance participation of the target population in future interventions . Methods We hypothesised that women who agreed to participate would have higher diabetes risk profiles than those who declined , and secondly that it would be possible to predict participation on the bases of those risk factors . To test our hypothesis , we identified the subset of women for whom we had comprehensive data on diabetes risks factors 3 - 5 years following GDM , reducing the sample to 43 participants and 73 decliners . We considered established diabetes risk factors : smoking , daily fruit and vegetable intake , participation in exercise , family history of diabetes , glucose values and BMI scores on post-partum re-screens , use of insulin during pregnancy , and age at delivery . We also analysed narrative data from 156 decliners to further underst and barriers to and facilitators of participation . Results Two factors differentiated participants and decliners : age at delivery ( with women older than 34 years being more likely to participate ) and insulin use during pregnancy ( with women requiring the use of insulin in pregnancy less likely to participate ) . Binary logistic regression confirmed that insulin use negatively affected the odds of participation . The most significant barriers to participation included the accessibility , affordability and practicality of the intervention . Conclusions Women with recent GDM face multiple barriers to lifestyle change . Intervention design ers should consider : ( i ) the practicalities of participation for this population , ( ii ) research design s that capitalise on motivational differences between participants , ( iii ) alleviating concerns about long-term diabetes management . We hope this work will support future research ers in developing interventions that are more relevant , effective and successful in recruiting the desired population .Trial registration Current Controlled Trials IS RCT OBJECTIVES Shoulder complaints ( SCs ) constitute the second largest group of musculoskeletal disorders after low back pain . The economic burden in terms of costs of healthcare use and costs due to work absenteeism underlines the need for a cost-effectiveness analysis of the interventions involved . The education and activation program ( EAP ) is a newly developed early intervention to prevent the development of chronic SCs . A cost-effectiveness analysis should provide more information on the effect of an EAP on total costs related to SCs . METHODS We conducted a cost-effectiveness analysis alongside a r and omized clinical trial comparing the effectiveness of the EAP in addition to usual care ( EAP group ) with that of usual care alone ( UC group ) in terms of preventing chronicity in patients with acute SCs . The aim of the cost-effectiveness analysis was to compare the observed difference in costs with the clinical effectiveness ( i.e. , patient-perceived recovery after 26 weeks ) , using bootstraps . RESULTS The comparison of total costs between treatment groups showed no significant ( p = .077 ) difference after 26 weeks . The majority ( 82 percent ) of the cost-effect pairs after bootstrap analysis were located in the northeast quadrant , suggesting more effect but at higher costs . CONCLUSIONS In view of the clinical relevance of the clinical outcomes and the considerable costs needed to achieve this , it can be concluded that the EAP is currently not cost-effective The aim of this study was to investigate post-operative pain intensity , analgesic consumption and the incidence of chronic pain  in women after different types of breast cancer surgery . Patients were r and omized to either patient-controlled analgesia or nurse-administered analgesia .  Opioid-consumption was registered for 24 h. A division of the patient- material into four subgroups was performed : ( 1 ) mastectomy ; ( 2 ) mastectomy and axillary lymph node dissection ; ( 3 ) mastectomy and reconstruction ; and ( 4 ) mastectomy , reconstruction and axillary lymph node dissection .  Visual analogue scale was used to measure pain intensity . Four years after surgery , a question naire regarding persistent pain was completed . Patients undergoing reconstruction scored higher pain levels than the others . Patient-controlled analgesia provided better pain relief but also considerably higher consumption of opioids by the women who underwent breast reconstruction . The incidence of remaining pain was 25 % after 3 - 4 years . Immediate breast reconstruction causes severe post-operative pain that can respond poorly to opioids . Chronic pain after breast cancer surgery is common and should be further analysed aim ing at better prevention and treatment options Objectives : To prospect ively describe the prevalence and predictive factors of  chronic postsurgical pain ( CPSP )  and poor global recovery in a large outpatient population at a university hospital , 1 year after outpatient surgery . Material s and Methods : A prospect i ve longitudinal cohort study was performed . During 18 months , patients presenting for preoperative assessment were invited to participate . Outcome parameters were measured by using question naires at 3 timepoints : 1 week preoperatively , 4 days postoperatively , and 1 year postoperatively . A value of > 3 on an 11-point numeric rating scale was considered to indicate moderate to severe pain . A score of ⩽80 % on the Global Surgical Recovery Index was defined as poor global recovery . Results : A total of 908 patients were included . The prevalence of moderate to severe preoperative pain was 37.7 % , acute postsurgical pain 26.7 % , and CPSP 15.3 % . Risk factors for the development of CPSP were surgical specialty , preoperative pain , preoperative analgesic use , acute postoperative pain , surgical fear , lack of optimism , and poor preoperative quality of life . The prevalence of poor global recovery was 22.3 % . Risk factors for poor global recovery were recurrent surgery because of the same pathology , preoperative pain , preoperative analgesic use , surgical fear , lack of optimism , poor preoperative and acute postoperative quality of life , and follow-up surgery during the first postoperative year . Discussion : Moderate to severe CPSP after outpatient surgery is common , and should not be underestimated . Patients at risk for developing CPSP can be identified during the preoperative phase Abstract This study aims to compare the isokinetic profile of hip abductor and adductor muscle groups between soccer players suffering from chronic adductor-related groin pain ( ARGP ) , soccer players without ARGP and healthy volunteers from general population . Study included 36 male professional soccer players , who were r and omly selected and followed-up over two years . Of the 21 soccer players eligible to participate in the study , 9 players went on to develop chronic ARGP and 12 players did not . Ten healthy male volunteers were r and omly selected from the general population as a control group . Comparison between the abductor and adductor muscle peak torques for players with and without chronic ARGP found a statistically significant difference on the dominant and non-dominant sides ( p < .005 ) , with the abductor muscle significantly stronger than the adductor muscle . In the group of healthy volunteers , the adductor muscle groups were significantly stronger than the abductor muscle groups on both dominant and non-dominant sides ( p < .05 ) . For the group of players who had developed chronic ARGP , abductor – adductor torque ratios were significantly higher on the affected side ( p = .008 ) . The adductor muscle strength was also significantly decreased on the affected side . This imbalance appears to be a risk factor for adductor-related groin injury . Therefore , restoring the correct relationship between these two agonist and antagonist hip muscles may be an important preventative measure that should be a primary concern of training and rehabilitation programmes Background The management of dizziness in older patients is primarily diagnosis-oriented . However , in 40 % of older patients with dizziness , GPs are not able to identify an underlying cause , and a number of common underlying causes of dizziness can not ( or hardly ) be treated . In this study we will investigate the effectiveness of a prognosis-oriented approach in the management of dizziness in older patients . This prognosis-oriented approach comprises identification of patients at risk for chronic dizziness with persistent impairment by identifying risk factors for an unfavourable course of dizziness . Patients at risk for chronic dizziness with persistent impairment will be offered treatment addressing the identified modifiable risk factors . Methods / Design This study will be performed in primary care . An intervention study and a validation study will be conducted in a three-arm cluster r and omised design . In the intervention study we will investigate a risk factor guided multi-component intervention . The risk factor guided intervention includes : ( 1 ) medication adjustment in case of three or more prescribed fall-risk-increasing drugs , ( 2 ) stepped care in case of anxiety disorder and /or depression , and ( 3 ) exercise therapy in case of impaired functional mobility . The primary outcome measure is dizziness-related impairment , which will be assessed with the Dizziness H and icap Inventory . Secondary outcome measures are quality of life , anxiety disorder and depression , use of fall-risk-increasing drugs , dizziness frequency , fall frequency , and healthcare utilization . Discussion This study is , to date , the first study that will investigate the effectiveness of a prognosis-oriented approach for reducing dizziness-related impairment in older people in primary care . Offering treatment that addresses identified modifiable risk factors to patients at high risk for chronic dizziness is unique . The pragmatic design of this study will enable evaluation of the outcomes in real-life routine practice conditions . An effective intervention will not only reduce dizziness-related impairment , but may also decrease healthcare utilization and healthcare costs . The previously developed risk score that will be vali date d alongside the intervention study will enable GPs to identify patients at high risk for chronic dizziness with persistent impairment . Trial registration Netherl and s Trial Register ( identifier : NTR4346 ) , registration date 15 December 2013 Study Design . Prospect i ve inception cohort study . Objective . To investigate prospect ively whether pain-related fear predicts future perceived disability and participation in patients with acute low back pain ( LBP ) . Summary of Background Data . There are indications that fear of movement/(re)injury , as measured by the Tampa Scale for Kinesiophobia , is present early in an episode of LBP , and that it might be a predictor of future perceived disability and participation . Methods . A cohort of 555 patients with acute LBP included by general practitioners and physical therapists in primary care setting s was followed for 6 months . Results . Results indicate that baseline fear of movement/(re)injury was predictive of future perceived disability and , to a lesser extent ( and together with duration and radiation ) , of participation . Conclusions . The results suggest that interventions aim ed at reducing pain-related fear in the acute stage of LBP might prevent restrictions of activity and participation because of pain , and might be a way of preventing the transition from acute to chronic LBP A preliminary investigation was undertaken on 117 acute back pain cases , to assess the utility of counseling at the acute stage upon the course of recovery over the subsequent 6 months . In addition , the extent to which psychological reactions to acute injury would allow the ' tagging ' of individuals at risk for chronic pain problems , was studied . The minimal rehabilitation counseling proved inadequate to effect the course of recovery , but remarkably accurate predictions were possible at the sub-chronic point ( 3 months ) as to who would make complete recoveries Study Design . Population ‐based r and omized clinical trial . Objectives . To develop and test a model of management of subacute back pain , to prevent prolonged disability . Summary of Background Data . The present management of back pain seems inadequate , and development of innovative models has been urged . Methods . A model for the treatment of subacute work‐related back pain has been developed and evaluated in a population ‐based r and omized clinical trial . Workers ( n = 130 ) from eligible workplaces in the Sherbrooke area ( N = 31 ) , who had been absent from work for more than 4 weeks for back pain , were r and omized , based on their workplace , in one of four treatment groups : usual care , clinical intervention , occupational intervention , and full intervention ( a combination of the last two ) . The duration of absence from regular work and from any work was evaluated using survival analysis . Functional status and pain were compared at study entry and after 1 year of follow‐up . Results . The full intervention group returned to regular work 2.41 times faster than the usual care intervention group ( 95 % confidence interval 1.19‐4.89 ; P = 0.01 ) . The specific effect of the occupational intervention accounted for the most important part of this result , with a rate ratio of return to regular work of 1.91 ( 95 % confidence interval = 1.18‐3.10 ; P < 0.01 ) . Pain and disability scales demonstrated either a statistically significant reduction or a trend toward reduction in the three intervention groups , compared with the trend in the usual care intervention group . Conclusions . Close association of occupational intervention with clinical care is of primary importance in impeding progression toward chronicity of low back pain Background The increasing number of patients with chronic diseases represents a challenge for health care systems . The Chronic Care Model suggests a multi-component remodelling of chronic disease services to improve patient outcomes . To meet the complex and ongoing needs of patients , chronic disease prevention  and management ( CDPM ) has been advocated as a key feature of primary care producing better outcomes , greater effectiveness and improved access to services compared to other sectors . The objective of this study is to evaluate the adaptation and implementation of an  intervention  involving the integration of chronic disease prevention and management ( CDPM ) services into primary health care . Methods / Design The implementation of the intervention will be evaluated using descriptive qualitative methods to collect data from various stakeholders ( decision-makers , primary care professionals , CDPM professionals and patients ) before , during and after the implementation . The evaluation of the effects will be based on a combination of experimental design s : a r and omized trial using a delayed intervention arm ( n = 326 ) , a before- and -after design with repeated measures ( n = 163 ) , and a quasi-experimental design using a comparative cohort ( n = 326 ) . This evaluation will utilize self-report question naires measuring self-efficacy , empowerment , comorbidity , health behaviour , functional health status , quality of life , psychological well-being , patient characteristics and co- interventions . The study will take place in eight primary care practice s of the Saguenay region of Quebec ( Canada ) . To be included , patients will have to be referred by their primary care provider and present at least one of the following conditions ( or their risk factors ) : diabetes , cardiovascular diseases , chronic obstructive pulmonary disease , asthma . Patients presenting serious cognitive problems will be excluded . Discussion In the short-term , improved patient self-efficacy and empowerment are expected . In the mid-term , we expect to observe an improvement in health behaviour , functional health status , quality of life and psychological well-being . At the organizational level , the project should lead to coordinated service delivery , improved patient follow-up mechanisms and enhanced interprofessional collaboration . Integration of CDPM services at the point of care in primary care practice s is a promising innovation in care delivery that needs to be thoroughly evaluated . Trial registration Clinical Trials.gov Identifier : Introduction Three common haplotypes in the gene encoding catechol-O-methyltransferase ( COMT ) have been associated with pain modulation and the risk of developing chronic musculoskeletal pain , namely temporom and ibular disorder ( TMD ) . Haplotypes coding for higher enzymatic activity were correlated with lower pain perception . Rodent studies showed that COMT inhibition increases pain sensitivity through β2/3-adrenergic receptors . We hypothesized that the nonselective β-adrenergic antagonist propranolol will reduce clinical and experimental pain in TMD patients in a manner dependent on the individuals ' COMT diplotype . Methods Forty Caucasian female participants meeting the Research Diagnostic Criteria for TMD were genotyped for COMT polymorphisms and completed a r and omized , double-blind , placebo-controlled , two-period crossover pilot study . Each period consisted of a baseline assessment week followed by an intervention week ( propranolol or placebo ) . Changes in clinical pain ratings , psychological status , and responses to heat and pressure stimuli between baseline and intervention weeks were compared across periods . Results The number of patients reporting a reduction in pain intensity rating was greater during propranolol treatment ( P=0.014 ) compared with placebo . Propranolol significantly reduced a composite pain index ( P=0.02 ) but did not decrease other clinical and experimental pain ratings . When stratified by the COMT high activity haplotype , a beneficial effect of propranolol  on pain perception was noted in patients not carrying this haplotype , a diminished benefit was observed in the heterozygotes , and no benefit was noted in the homozygotes . Conclusion COMT haplotypes may serve as genetic predictors of propranolol treatment outcome , identifying a subgroup of TMD patients who will benefit from propranolol therapy OBJECTIVES To investigate self-reported chronic pain and other sequelae in a nationally representative sample of long-term breast cancer survivors ( BCS ) . DESIGN Age-stratified r and om sample of 2,000 female BCS 5 years after primary surgery without recurrence drawn from the Danish Breast Cancer Cooperative Group register , which is representative regarding long-term BCS in Denmark . ASSESSMENT Self-administered question naire including questions on sociodemography , chronic pain ( 6 months ) , health-related quality of life ( HRQOL ) and other sequelae related to breast cancer . Associations with treatment were investigated . Report of chronic pain was compared to normative data . RESULTS The response rate was 79 % . Chronic pain prevalence of 42 % was significantly higher in BCS compared to general population women ( SRR : 1.32 ; 95 % CI : 1.23 - 1.42 ) . Sequelae related to breast cancer were paraesthesia 47 % , chronic pain 29 % , arm/shoulder swelling 25 % , phantom sensations 19 % , and allodynia 15 % . Chronic pain related to breast cancer was significantly associated with poorer HRQOL and higher medicine consumption , and , in multiple logistic regression analysis , with age ( < 70 years ) , short education , being single ( divorced , widowed , separated ) , radiotherapy , and time since operation < 10 years . Radiotherapy and younger age were significantly associated with most sequelae . CONCLUSION Chronic pain was more prevalent in BCS compared to the general population . Significant predictors for sequelae related to breast cancer were radiotherapy and younger age . Future research should therefore prioritize sequelae prevention Palliative care at the end of life involves meeting the physical , psychological , social , and practical needs of patients and caregivers . End of life is defined as a phase of life when a person is living with an illness that will worsen and eventually cause death . It is not limited to the short period of time when the person is moribund ( 1 ) . Good clinical care can prevent or alleviate suffering for many patients at the end of life by assessing symptoms and providing psychological and social support to the patients and their families . The purpose of this guideline is to present the available evidence to improve palliative care at the end of life . This guideline does not address any other setting s of palliative care at the end of life . The target audience for this guideline is all clinicians caring for patients needing end-of-life care . The target patient population is everyone with seriously disabling or symptomatic chronic conditions at the end of life . These recommendations are based on the systematic evidence review in the background paper in this issue by Lorenz and colleagues ( 1 ) , which is based on an Agency for Healthcare Research and Quality ( AHRQ ) evidence report ( 2 ) . End-of-life care has been identified by the Institute of Medicine as one of the priority areas to improve quality of health care ( 3 ) . The Institute of Medicine report identified specific gaps related to end-of-life care , such as pain control in advanced cancer and care for patients with advanced organ failure . High- quality evidence on end-of-life care is limited , and most of the evidence is derived from the literature that focused on patients with cancer ; therefore , this guideline does not address many important aspects of end-of-life care . For example , nutritional support , complementary and alternative therapies , and spiritual care were not part of the review . If an end-of-life intervention is not addressed in this guideline , it does not mean that no benefit is related to that particular intervention , but it indicates that the intervention has not been sufficiently studied to demonstrate efficacy . Some important topics in end-of-life care , such as interpersonal and social interventions , may be especially difficult to study . The American College of Physicians ' End-of-Life Care Consensus Panel has a series of papers related to ethical issues around end-of-life care that can be accessed from its Web site ( www.acponline.org/ethics/papers.htm ) . Methods The literature search for this guideline included studies from MEDLINE and review s of cancer , congestive heart failure , and dementia from the Data base of Abstract of Review s of Effects from January 1990 to November 2005 . Citations from the non systematic literature were taken from the review by the National Consensus Project for Quality Palliative Care ( 4 ) . The review included only English- language publications from the United States , Canada , Western Europe , Australia , and New Zeal and . Details about the methods used for the systematic evidence review may be found in detail in the background paper in this issue ( 1 ) . The objective for this guideline was to answer the following questions : 1 . What are the critical elements for clinicians to address when caring for persons coming to the end of life ? 2 . What do definitions of the end of life suggest about identifying patients who could benefit from palliative approaches  ? 3 . What treatment strategies work well for pain , dyspnea , and depression ? 4 . What elements are important in advance care planning for patients coming to the end of life ? 5 . What elements of collaboration and consultation are effective in promoting improved end-of-life care ? 6 . What elements of assessment and support are effective for serving caregivers , including family , when patients are coming to the end of life ? This guideline grade s the evidence and recommendations using the American College of Physicians ' clinical practice guidelines grading system , adopted from the classification developed by the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) workgroup ( Table ) . Table . The American College of Physicians ' Guideline Grading System * Critical Elements for End-of-Life Care There is a wide range of critical elements for patients nearing the end of life , as well as for their caregivers . Preventing and treating pain and other symptoms ; supporting families and caregivers ; ensuring the continuity of care ; ensuring respect for persons and informed decision making ; attending to well-being , including existential and spiritual concerns ; and supporting function and survival duration are general issues that are common for most end-of-life care patients ( 411 ) . Identifying Patients Who Could Benefit from  Palliative Approaches The literature review did not identify any evidence -based tools that have been vali date d and shown to predict the optimal timing to initiate palliative care services . Decisions to initiate palliative care at the end of life should be individualized on the basis of patient symptoms and preferences . Treatment Strategies Pain Strong evidence from trials of patients with cancer supports the use of nonsteroidal anti-inflammatory drugs , opioids , bisphosphonates , and radiotherapy or radiopharmaceuticals for pain ( 12 ) . Bisphosphonates are specifically effective for bone pain . However , head-to-head comparisons of specific drugs or reports on delivery strategies are difficult to do because of method ological issues and heterogeneity ( 12 ) . Evidence was insufficient to assess the usefulness of exercise or acupuncture in pain management ( 13 , 14 ) . A meta- analysis that included 43 studies showed that palliative care teams are modestly beneficial in providing care for pain management compared with usual care teams ( effect size , 0.13 SD [ 95 % CI , 0.11 to 0.63 SD ] ) ( 15 ) . Other studies that evaluated quality of life showed no difference ( 16 ) and no effect of palliative care consultation ( in contrast to palliative care teams ) on pain scores ( 17 ) . Dyspnea Evidence from 13 studies shows a valuable effect of morphine for dyspnea in advanced lung disease ( st and ardized mean difference , 0.31 [ CI , 0.50 to 0.13 ] ) ( 18 ) . This is also supported by other studies that show the benefits of morphine for treating dyspnea in advanced lung disease and terminal cancer ( 19 , 20 ) . However , using nebulized opioids compared with oral opioids showed no additional benefit . Also , 1 study showed that dihydrocodeine result ed in a statistically but not clinical ly significant increase in Pco 2 during treatment ( 18 ) . Good- quality evidence shows that long-acting -agonists are beneficial in the treatment of dyspnea in chronic obstructive pulmonary disease ( 21 ) . Twelve studies evaluated various interventions for reducing dyspnea in patients with chronic obstructive pulmonary disease , heart failure , cancer , or all conditions . Evidence was mixed when comparing oxygen therapy with room air . One study showed better oxygen saturation , respiratory effort and rate , and dyspnea with oxygen ( 19 ) . However , Bruera and colleagues ( 20 ) showed no difference in dyspnea and fatigue between oxygen and air after a 6-minute walk test . Studies that evaluated service delivery showed no effect of facilitated patientprovider communication or palliative care consultation for dyspnea treatment ( 16 , 17 , 22 , 23 ) . Depression Good evidence supports the effectiveness of long-term use of tricyclic antidepressants or selective serotonin reuptake inhibitors , as well as psychosocial interventions ( education , cognitive and noncognitive behavioral therapy , informational interventions , and individual and group support ) for treating patients with cancer who have depression ( 12 ) . Gysels and Higginson ( 24 ) identified 15 intervention studies that showed that behavioral interventions were effective in the treatment of depression , whereas 1 complementary medicine intervention was ineffective for depression ( 24 ) . Evidence for using guided imagery and exercise showed mixed results ( 13 , 25 ) . Palliative care for out patients did not have any effect on depression and anxiety , and care coordination showed no effect on  depression  in patients with cancer near the end of life ( 22 , 23 , 26 , 27 ) . Important Elements for Advance Care Planning Research shows that individuals are more likely to use advance directives in the presence of extensive multicomponent interventions than with limited interventions ( 28 , 29 ) . One study showed that hospice use increased when goal -oriented interviews and decisions between palliative care facilitators and patients were communicated to nursing home physicians ( 30 ) . In addition , another study showed an increase in documented treatment limitations and preference-concordant care for patients served by social workers trained in care planning ( 31 ) . Also , proactive communication from skilled discussants , such as an ethics team , can help reduce utilization of unnecessary services without harming patients or family members ( 32 , 33 ) . In summary , various processes , such as consulting caregivers , enhancing clear communication , eliciting values , and addressing the emotional context , are important elements for comprehensive advance care planning . Clinicians should help patients and families plan in advance for likely or important clinical decisions . Collaboration and Consultation to Improve End-of-Life Care Studies have shown that the following factors improve utilization outcomes and patient-centered outcomes : multidisciplinary teams involving nurses and social services , continuity of care and service coordination , and facilitated communication . A meta- analysis of 29 r and omized , controlled trials done by McAlister and colleagues ( 34 ) showed that follow-up by a multidisciplinary team result ed in decreased hospitalizations due to heart failure . In addition , a multidisciplinary approach also improved patients ' quality of life and functional status ( 34 , 35 ) . Another intervention study showed that coordination between primary physician and Background The evidence that higher levels of physical activity and /or lower levels of physical inactivity are associated with beneficial health-related outcomes stems mainly from observational studies . Findings from these studies often differ from r and omised controlled trials and systematic review s currently demonstrate mixed results , due partly to heterogeneity in physical activity interventions , method ologies used and population s studied . As a result , translation into clinical practice has been difficult . It is therefore essential that an overview is carried out to compare and contrast systematic review s , and to identify those physical activity interventions that are the most effective in preventing and /or treating major chronic disease . This protocol has been registered on PROSPERO 2013 : CRD42013003523 . Methods We will carry out an overview of Cochrane systematic review s. We will search the Cochrane Data base of Systematic Review s for systematic review s of r and omised controlled trials that have a primary focus on disease-related outcomes . We will restrict review s to those in selected major chronic diseases . Two authors will independently screen search outputs , select studies , extract data and assess the quality of included review s using the assessment of multiple systematic review s tool ; all discrepancies will be resolved by discussing and reaching a consensus , or by arbitration with a third author . The data extraction form will summarise key information from each review , including details of the population ( s ) ( for example , disease condition ) , the context ( for example , prevention , treatment or management ) , the participants , the intervention(s ) , the comparison(s ) and the outcomes . The primary outcomes of interest are the prevention of chronic disease and /or improved outcomes , in the treatment or management of chronic disease . These outcomes will be summarised and presented for individual chronic diseases ( for example , any change in blood pressure in hypertension or glucose control in diabetes ) . Secondary outcomes of interest are to describe the structure and delivery of physical activity interventions  across chronic disease conditions and adverse events associated with physical activity . Discussion We anticipate that our results could inform research ers , guideline groups and policymakers of the most efficacious physical activity interventions in preventing and /or managing major chronic disease Diabetes is an “ old disease ” . The first description of diabetes written on papyrus about 3500 years ago is found in the Ebers papyrus  , which was discovered in Egypt in 1873 by the German archeologist Georg Ebers . Humans , like most mammals , may develop diabetes , if sufficient environmental exposure to physical inactivity , unhealthy diet and obesity are present . Genetic effects are important for the individual risk of type 2 diabetes ( T2D ) but twin studies have shown that the genetic effects combined explain less than 50 % of the risk of T2D ( 1 ) . Today we know almost 100 susceptibility genes associated with T2D but the relative importance of each of these genes is low ( 2 ) , and together they explain only a small part of the disease risk . Thus , genetic screening can not be used for the prediction of T2D for individuals . On the other h and , healthy lifestyle can also prevent T2D in people who are genetically at high risk , e.g. those with positive family history ( 3 ) . Thus , the importance of lifestyle factors for the development and prevention of T2D is overwhelming . The strongest evidence in medicine is considered to come from r and omized controlled trials ( RCTs ) . They are also important in providing the link to causal inference that in most observational studies can not be derived . At the same time , observational studies are necessary for the identification of factors associated with an increased or decreased risk of a disease , and for generation of hypotheses on potential means for prevention based on modifiable risk factors . Observational studies have by now identified a large number of factors that are associated with the development of T2D or with the protection against it . Most of them are related to physical activity , diet and obesity . It has also been shown unequivocally that exposures ( poor nutrition , infections , smoking , etc . ) during fetal life and early infancy result ing in insufficient development ( often shown as low birth weight ) also predict T2D later in life ( 4 ) . Traditionally , T2D has been considered to be a disease of the elderly . However , with increasing obesity and sedentary lifestyle in children , there are increasing numbers of cases of T2D already occurring at a young age in many population s ( 5 ) . In the past two decades several innovative RCTs have repeatedly shown that interventions on modifiable risk factors can reduce the incidence of diabetes in high-risk groups . The evidence has been summarized in several systematic review s and meta-analyses ( 6,7 ) . There is compelling scientific evidence from RCTs that T2D can be prevented or its onset delayed . The key for prevention is a multimodal package of lifestyle changes that is a sum outcome of dietary and physical activity behaviours . The power of lifestyle was dramatically illustrated by the Finnish Diabetes Prevention Study ( DPS ) that explicitly showed that when the study participants with impaired glucose tolerance reached all five modest lifestyle intervention targets , none of them progressed to T2D ( 8) . Importantly , lifestyle intervention lasting for 3–6 years has been shown to have a carry-over effect on T2D incidence that lasts for several years ; up to 15 in the Finnish Diabetes Prevention Study ( 9 ) and 20 years in the China Da Qing Diabetes Prevention Study ( 10 ) . The observed sustained risk reduction seems to be a result of sustained lifestyle changes , but the legacy effect of improved glycaemia during the early intervention may also have contributed to the long-term effect . The follow-up data from the Chinese study indicate moreover that vascular risks are also reduced by lifestyle management . Several prognostic question naires exist for detecting people at risk of T2D ( 11 ) . One of the screening tools with an adequately high sensitivity and specificity is the Finnish Diabetes Risk Score ( FINDRISC ) developed in Finl and ( 12 ) . The FINDRISC has been successfully implemented in the Finnish primary health care system and used also in many other countries . The FINDRISC was also tested in the Omani population and as a result a slightly modified Omani Diabetes Risk Score was developed ( 13 ) which may be a suitable screening tool for the Arab population s in the Middle East . Lifestyle interventions aim ing at translating evidence from efficacy RCTs on T2D prevention into “ real world ” intervention programmes have also been carried out in various population s. Such data were recently combined in a meta- analysis considering the relationship between intervention effectiveness and adherence to guidelines ( 14 ) . The primary meta- analysis included 22 studies with outcome data for weight loss at 12 months . The pooled result of the direct pairwise meta- analysis shows that OBJECTIVE To compare excisional and ablative treatment modalities for mild ( revised American Fertility score 1 - 2 ) endometriosis in the management of  chronic pelvic pain .  DESIGN A r and omized study of excision or ablation for mild endometriosis , participants and investigators alike blinded to the treatment modality at the follow-up visit . SETTING District general hospital with a specialist pelvic pain clinic in the United Kingdom . PATIENT(S ) Women presenting with chronic pelvic pain . INTERVENTION(S ) Participants were asked to complete a question naire detailing symptoms related to chronic pelvic pain and rating their pain on a ranked ordinal scale . Areas of pelvic tenderness were identified and similarly ranked . At laparoscopy they were r and omly assigned to excision or ablation of any endometriotic lesions , and the question naire was repeated at 6 months . MAIN OUTCOME MEASURE(S ) Changes in pain score on a ranked ordinal scale after surgical treatment for mild endometriosis . RESULT ( S ) Both treatment modalities produced good symptomatic relief and reduction of pelvic tenderness ( 67 % ) . There was no difference in morbidity ; one woman in each group became pregnant during the study period . Only two participants reported no relief or a worsening of symptoms or signs . CONCLUSION ( S ) This small study showed good symptom relief at 6 months from pelvic pain for the majority of participants irrespective of the treatment modality , but two participants did not improve or got worse . A high pain score before treatment was a predictor of appreciable improvement . Further work is needed to identify women in whom surgical intervention is likely to produce a good response This paper discusses the rationale for and content of a newly developed treatment for shoulder complaints , and describes a r and omised study which is currently being conducted to test effectiveness of the treatment . In current practice , approximately 50 % of all patients with shoulder complaints mention limitations in the performance of daily activities and persisting pain after six months . To improve the functional ability of patients with chronic shoulder complaints , despite their pain , we have developed an operant behavioural and time-contingent grade d exercise therapy programme for use in a primary care setting . We present the theory and conceptual model underlying this programme , report on its development and content , and describe the design of a r and omised clinical trial to evaluate the programme 's effectiveness and cost-effectiveness . One hundred and thirty-two patients who suffer from shoulder complaints for at least 3 months are being recruited in general practice . After inclusion in the study , patients are allocated r and omly to the grade d exercise therapy programme or to usual care . Question naires will be used to measure factors like severity of the main complaint , functional limitations of daily activities , perceived recovery , global health status , shoulder pain , generic health-related quality of life , and costs . These factors will be assessed at baseline , during treatment ( 6 weeks ) , and after treatment ( 12 , 26 , and 52 weeks ) BACKGROUND Chronic pain is recognised as an important problem in the community but our underst and ing of the epidemiology of chronic pain remains limited . We undertook a study design ed to quantify and describe the prevalence and distribution of chronic pain in the community . METHODS A r and om sample of 5036 patients , aged 25 and over , was drawn from 29 general practice s in the Grampian region of the UK and surveyed by a postal self-completion question naire . The question naire included case-screening questions , a question on the cause of the pain , the chronic pain grade question naire , the level of expressed needs question naire , and sociodemographic questions . FINDINGS 3605 question naires were returned completed . 1817 ( 50.4 % ) of patients self reported chronic pain , equivalent to 46.5 % of the general population . 576 reported back pain and 570 reported arthritis ; these were the most common complaints and accounted for a third of all complaints . Backward stepwise logistic-regression modelling identified age , sex , housing tenure , and employment status as significant predictors of the presence of chronic pain in the community . 703 ( 48.7 % ) individuals with chronic pain had the least severe grade of pain , and 228 ( 15.8 % ) the most severe grade . Of those who reported chronic pain , 312 ( 17.2 % ) reported no expressed need , and 509 ( 28.0 % ) reported the highest expressed need . INTERPRETATION Chronic pain is a major problem in the community and certain groups within the population are more likely to have chronic pain . A detailed underst and ing of the epidemiology of chronic pain is essential for efficient management of chronic pain in primary care Background Pelvic inflammatory disease ( PID ) is common and can lead to tubal factor infertility , ectopic pregnancy or chronic pelvic pain . Despite major UK government investment in the National Chlamydia Screening Programme , evidence of benefit remains controversial . The main aim of this trial was to investigate whether screening and treatment of chlamydial infection reduced the incidence of PID over 12 months . Secondary aims were to conduct exploratory studies of the role of bacterial vaginosis ( BV ) in the development of PID and of the natural history of chlamydial infection . Design R and omised controlled trial with follow up after 12 months . Setting non-healthcareCommon rooms and lecture theatres at 20 universities and further education colleges in Greater London . Participants 2500 sexually active female students were asked to complete a question naire on sexual health and provide self-administered vaginal swabs and smears . InterventionVaginal swabs from intervention women were tested for chlamydia by polymerase chain reaction ( PCR ) and those infected referred for treatment . Vaginal swabs from control women were stored and analysed after a year . Vaginal smears were Gram stained and analysed for BV.Main outcome measureIncidence of clinical PID over 12 months in intervention and control groups . Possible cases of PID will be identified from question naires and record search es . Confirmation of the diagnosis will be done by detailed review of medical records by three independent research ers blind to whether the woman is in intervention or control group . Trial registration Clinical Trials NCT
Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
Although certain risk factors can identify individuals who are most likely to develop chronic pain , few interventions to prevent chronic pain have been identified .
To facilitate the identification of preventive interventions , an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain .
We present general design considerations for prevention trials in population s that are at relatively high risk for developing chronic pain .