A pilot study of botulinum toxin A for male chronic pelvic pain syndrome Should women with chronic pelvic pain have adhesiolysis? GaPP: a pilot randomised controlled trial of the efficacy of action of gabapentin for the management of chronic pelvic pain in women: study protocol Prevalence and correlates of three types of pelvic pain in a nationally representative sample of Australian women. Correlation between endometriosis and pelvic pain. Short-term results of bilateral S2-S4 sacral neuromodulation for the treatment of refractory interstitial cystitis, painful bladder syndrome, and chronic pelvic pain. Efficacy of static magnetic field therapy in chronic pelvic pain: a double-blind pilot study. 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Abstract Objective . Male chronic pelvic pain syndrome ( CPPS ) has been the subject of numerous clinical trials , but so far , no uniformly effective treatment has been identified . A commonly reported tender spot in men with CPPS is the bulbospongiosus muscle . A r and omized placebo controlled pilot trial of botulinum toxin A ( BTX-A ) injection into the perineal skeletal musculature for the treatment CPPS was conducted . Material and methods . Twenty-nine men with CPPS were identified from a urology clinic . Symptom evaluation was performed using a Global Response Assessment ( GRA ) and the Chronic Prostatitis Symptom Index ( CPSI ) .  All subjects were r and omized to receive either BTX-A 100 U or normal saline injected into the perineal body and bulbospongiosus muscle . Results . BTX-A  injection was administered in 13 men . At the 1 month follow-up there was a 30 % response rate for BTX-A treatment compared with 13 % for placebo ( p = 0.0002 ) , based on GRA results . Total CPSI score did not reach significance in the BTX-A-treated group , compared with controls . The CPSI pain subdomain score reached statistical significance in the BTX-A patients compared with controls ( p = 0.05 ) . The injections were well tolerated . There were no complications from the injections and no patients reported side-effects . Conclusions . BTX-A injection into the perineal body and bulbospongiosus muscle results in a modest response rate on the GRA compared with placebo for overall symptoms associated with CPPS . The treatment is well tolerated and safe . BTX-A use may enhance polytherapeutic pain management Background Pelvic adhesions are found in up to 50 % of women with CPP during investigative surgeries and adhesiolysis is often performed as part of their management although the causal or casual association of adhesions , and the clinical benefit of adhesiolysis in the context of CPP is still unclear . Our aim was to test the hypothesis of whether laparoscopic adhesiolysis leads to significant pain relief and improvement in quality of life ( QoL ) in patients with chronic pelvic pain ( CPP ) and adhesions . Methods This was a double-blinded RCT . This study was conducted in 2 tertiary referral hospitals in United Kingdom over 4 years . Women with chronic pelvic pain ( CPP ) were r and omized into having laparoscopic adhesiolysis or diagnostic laparoscopy .  Women were assessed at 0 , 3 and 6 months for Visual analogue scale scores ( VAS ) and Quality of Life ( QoL ) measures ( SF-12 and EHP-30 ) . Results A total of 92 participants were recruited ; 50 qualified to be r and omized , with 26 in the adhesiolysis and 24 in the control group . The results are expressed in median ( interquartile ranges ) . In women who underwent adhesiolysis , there was a significant improvement at 6 months in VAS scores ( -17.5 ( -36.0 - -5.0 ) compared to controls ( -1.5 ( -15.0 – 4.5 ; p = 0.048 ) ; SF-12 scores physical component score ( 25.0 ( 18.8 – 43.8 ) ) compared to controls ( 6.3 ( -6.3 – 18.8 ) ; p = 0.021 ) , SF-12 emotional component score 32.5 ( 4.4 – 48.8 ) compared to controls -5 ( -21.3 – 15.0 ) ; p < 0.0074 ) and EHP-30 emotional well being domain 32.5 ( 4.4 – 48.8 ) compared to the controls -5 ( -21.3 – 15.0 ; p < 0.0074 ) . Conclusions This study stopped before recruitment reached the statistically powered sample size due to difficulty with enrollment and lack of continued funding . In selected population of women presenting to the gynecological clinic with chronic pelvic pain , adhesiolysis in those who have adhesions may be of benefit in terms of improvement of pain and their quality of life . Trial registration numberIS RCT N Introduction Chronic pelvic pain ( CPP ) affects > 1 million UK women . Annual healthcare costs are estimated at > £ 150 million . Proven interventions for CPP are limited , and treatment is often unsatisfactory . Gabapentin is increasingly prescribed due to reports of effectiveness in other chronic pain conditions , but there are insufficient data supporting value in CPP specifically . The mechanism by which gabapentin exerts its analgesic action is unknown . Given the prevalence and costs of CPP , the authors believe that a large , multicentre , placebo-controlled , double-blind r and omised controlled trial to evaluate the efficacy of gabapentin in management of CPP is required . The focus of this study is a pilot to inform planning of a future r and omised controlled trial . Methods and analysis The authors plan to perform a two-arm , parallel , r and omised controlled pilot trial . The authors aim to recruit 60 women with CPP in NHS Lothian and NHS Grampian ( UK ) and r and omise them to gabapentin or placebo . Response to treatment will be monitored by question naire compared at 0 , 3 and 6 months . The primary objective is to assess recruitment and retention rates . The secondary objectives are to determine the effectiveness and acceptability to participants of the proposed methods of recruitment , r and omisation , drug treatments and assessment tools and to perform a pretrial cost-effectiveness assessment of treatment with gabapentin . Ethics and dissemination Ethical approval has been obtained from the Scotl and A Research Ethics Committee ( LREC 12/SS/0005 ) . Data will be presented at international conferences and published in peer- review ed journals . Trial registration number IS RCT N70960777 OBJECTIVE To identify the prevalence and correlates of three types of pelvic pain ( dysmenorrhoea , dyspareunia , and other chronic pelvic pain [ CPP ] ) in a nationally representative sample of Australian women . DESIGN AND SETTING The CPP survey was part of a broader national study of health and relationships . Computer-assisted telephone interviews were administered to a r and om sample of 8656 Australian households ; 4366 women aged between 16 and 64 years were interviewed in 2004 and 2005 . Eighteen of the more than 200 potential survey questions related to pelvic pain . MAIN OUTCOME MEASURES Self-reports of dysmenorrhoea , dyspareunia , and any other CPP not associated with sexual intercourse or menstruation . RESULTS Data on 1983 women aged 16 - 49 years who were still menstruating and sexually active were analysed . Prevalences were 71.7 % for dysmenorrhoea , 14.1 % for dyspareunia and 21.5 % for other CPP ; 23.3 % of women reported no pelvic pain of any kind . Severe pain was reported by 15.0 % ( 95 % CI , 13.0%-17.1 % ) of women with dysmenorrhoea , 7.8 % ( 95 % CI , 5.0%-11.9 % ) of women with dyspareunia and 20.0 % ( 95 % CI , 16.1%-24.6 % ) of women with other CPP . Just over a third ( 34.2 % ) of women who reported any pain had sought advice from a health professional . Women reporting CPP were also likely to report other health conditions , most notably depression and anxiety . There were clear associations between CPP and sexual difficulties , pregnancy and pregnancy outcomes . CONCLUSIONS Rates of pelvic pain in Australian women are high . General practitioners need to be ready to discuss these issues with patients , particularly in relation to underlying anxiety and depression STUDY OBJECTIVE To evaluate the relationship between prevalence and severity of  chronic pelvic pain ( CPP ) and stage , site , and type of endometriosis . DESIGN Prospect i ve , observational study ( Canadian Task Force classification II-2 ) . SETTING University Hospital . PATIENTS Of 90 consecutive women with biopsy-proved endometriosis , laparoscopy was performed in 69 for pelvic pain and in 21 for infertility or clinical and ultrasonographic suspicion of ovarian endometriosis . INTERVENTION Preoperatively , using a 10-point visual analog scale , the severity of dysmenorrhea , CPP , and deep dyspareunia was assessed . During laparoscopy all visible endometriotic lesions were recorded and treated . MEASUREMENTS AND MAIN RESULTS Ten women ( 11.1 % ) had no pain ; 72 had dysmenorrhea ( mild in 13 , moderate in 37 , severe in 22 ) ; 55 had CPP ( mild in 11 , moderate in 25 , severe in 19 ) ; and 39 deep dyspareunia ( mild in 5 , moderate in 31 , severe in 3 ) . The severity of dysmenorrhea significantly correlated with the presence and extent of pelvic adhesions ( p = 0.004 ) ; the severity of CPP correlated with deep endometriosis on the uterosacral ligaments ( p = 0.0001 ) and extent of pelvic adhesions ( p = 0.02 ) ; and deep dyspareunia correlated with deep endometriosis on the uterosacral ligaments ( p = 0.04 ) . Total pain score significantly correlated with deep endometriosis on the uterosacral ligaments ( p = 0.0001 ) , peritoneal adhesions ( p = 0.01 ) , and extent of adnexal adhesions ( p = 0.01 ) . No significant correlation was found among revised American Fertility Society stage of endometriosis ; presence and size of ovarian endometriomas ; extent , type , and site of peritoneal lesions ; and pain scores . By logistic regression analysis , the presence and intensity of total pain could be predicted simultaneously by the presence of deep endometriosis ( p = 0.0001 ) and presence and extent of adnexal adhesions without cystic endometriosis ( p = 0.01 ) , and by the presence of ovarian endometrioma with periovarian adhesions ( p = 0.03 ) . Chronic pelvic pain was predicted by both deep endometriosis ( p = 0.0001 ) and ovarian endometriomas with adnexal adhesions ( p = 0.03 ) . Deep dyspareunia was predicted simultaneously by deep endometriosis ( p = 0.01 ) and an ovarian endometrioma with periovarian adhesions ( p = 0 . 008 ) . Conclusion . Deep endometriosis , pelvic adhesions , and ovarian cystic endometriosis were independent predictors of pelvic pain . These data strongly suggest that it is not the size of ovarian cystic endometriosis but the association with adhesions that causes pelvic pain We evaluated the efficacy of bilateral caudal epidural sacral neuromodulation for the treatment of refractory chronic pelvic pain ( CPP ) , painful bladder syndrome , and interstitial cystitis ( IC ) . Thirty consecutive patients ( 21 female , 9 male ) with severe refractory symptoms underwent bilateral S2-S4 sacral neuromodulation for CPP/IC . Patients were evaluated with the O'Leary IC symptom and problem index ( ICSI , ICPI ) , the short form of the Urogenital Distress Inventory ( UDI-6 ) , and the R AND 36-item health survey ( SF-36 ) preoperatively and 6 months postoperatively . The mean and minimum follow-up were 15 and 6 months , respectively . Of the 30 patients , 23 ( 77 % ) had a successful trial stimulation and were permanently implanted . Among these patients , the ICSI and ICPI scores improved by 35 ( p = 0.005 ) and 38 % ( p = 0.007 ) , respectively . The pain score improved by 40 % ( p = 0.04 ) and the UDI-6 score by 26 % ( p = 0.05 ) . On average , patients reported a 42 % improvement in their symptoms . SF-36 scores did not improve significantly . In refractory patients , bilateral caudal epidural sacral neuromodulation is another possible mode of treatment , which appears to improve both pelvic pain and voiding symptoms OBJECTIVE The aim of the study was to determine the efficacy of static magnetic field therapy for the treatment of  chronic pelvic pain ( CPP ) by measuring changes in pain relief and disability . STUDY DESIGN Thirty-two patients with CPP completed 2 weeks and 19 patients completed 4 weeks of r and omized double-blind placebo-controlled treatment at a gynecology clinic .  Active ( 500 G ) or placebo magnets were applied to abdominal trigger points for 24 hour per day . The McGill Pain Question naire , Pain Disability Index , and Clinical Global Impressions Scale were outcome measures . RESULTS Patients receiving active magnets who completed 4 weeks of double-blind treatment had significantly lower Pain Disability Index ( P < .05 ) , Clinical Global Impressions-Severity ( P < .05 ) , and Clinical Global Impressions-Improvement ( P < .01 ) scores than those receiving placebo magnets , but were more likely to correctly identify their treatment ( P < .05 ) . CONCLUSION SMF therapy significantly improves disability and may reduce pain when active magnets are worn continuously for 4 weeks in patients with CPP , but blinding efficacy is compromised This article reports the findings of a population -based study in New Zeal and that investigated comparative well-being , comorbidity , and the impact of chronic pelvic pain ( CPP ) on activities . Chronic pelvic pain was defined as lower abdominal pain that is associated with neither the menstrual cycle nor sexual activity . A postal question naire was administered to a r and om sample result ing in a study group of 1,160 . The negative impact of CPP on women 's general well-being is significant . They were more likely than women without CPP to have other long-st and ing illnesses , other unspecified conditions involving pain or fatigue , and sleep patterns were more seriously disturbed . Pain restricted their activities . Comparisons with the limited data available from other studies are made Objectives . To investigate the effectiveness of extracorporeal shock wave therapy ( ESWT ) for symptoms alleviation in chronic pelvic pain syndrome ( CPPS ) . Material s and Methods . 40 patients with CPPS were r and omly allocated into either the treatment or sham group . In the first group , patients were treated by ESWT once a week for 4 weeks by a defined protocol . In the sham group , the same protocol was applied but with the probe being turned off . The follow-up assessment s were done at 1 , 2 , 3 , and 12 weeks by Visual Analogue Scale ( VAS ) for pain and NIH-developed Chronic Prostatitis Symptom Index ( NIH-CPSI ) . Results . Pain domain scores at follow-up points in both treatment and sham groups were reduced , more so in the treatment group , which were significant at weeks 2 , 3 , and 12 . Urinary scores became significantly different at weeks 3 and 12 . Also , quality of life ( QOL ) and total NIH-CPSI scores at all four follow-up time points reduced more significantly in the treatment group as compared to the sham group . Noticeably , at week 12 a slight deterioration in all variables was observed compared to the first 3 weeks of the treatment period . Conclusions . our findings confirmed ESWT therapy as a safe and effective method in CPPS in short term OBJECTIVE The purpose of this study was to describe long-term outcomes for women with chronic pelvic pain ( CPP ) after evaluation in a CPP specialty clinic . STUDY DESIGN This was a prospect i ve observational cohort study of women treated for CPP at the UNC Pelvic Pain clinic between 1993 and 2000 . The primary outcome was improvement in pain and the main exposure was treatment group : primarily medical ( pharmacotherapy , psychotherapy , physical therapy , or combinations of the 3 ) or surgical ( hysterectomy , resection or ablative procedures , oophrectomy , diagnostic surgery , pain mapping , vulvar or vestibular repair ) . Univariate , bivariate , and multivariable analyses were performed to look for relationships between background characteristics , treatment group , and improvement in pain . RESULTS Of 370 participants ; 189 had surgical treatment and 181 had medical treatment . One year after evaluation , 46 % reported improvement in pain and 32 % improvement in depression . Improvement in pain was similar in both treatment groups and odds of improvement were equal even after adjusting for background characteristics , psychosocial comorbidity , and previous treatments . CONCLUSION One year after evaluation in a CPP specialty clinic , women experienced modest improvements in pain and depression after recommended surgical or nonsurgical treatment OBJECTIVE To evaluate the efficacy of intravaginal electrical stimulation in women with chronic pelvic pain ( CPP ) . STUDY DESIGN Between May 2002 and February 2004 , 24 women with CPP with no apparent cause were evaluated . They underwent 10 sessions of intravaginal electrical stimulation . A program for measuring chronic diffuse pain , with a frequency of 8 Hz , variation in intensity and frequency , pulse length of 1 msec , and adjustment to the bearable intensity of each individual patient ( in milliamps ) was utilized . Treatment consisted of 30-minute applications , 2 or 3 times per week , and the pain was evaluated using a visual analog scale before and after each session and immediately after completion of the total treatment . The women were asked to evaluate the pain 2 weeks , 4 weeks and 7 months following the end of treatment . RESULTS Intravaginal electrical stimulation was effective in alleviating pain in women with CPP , as evaluated at the end of treatment and 2 weeks , 4 weeks and 7 months after completion of treatment ( p<0.05 ) . There were significantly fewer complaints of dyspareunia following treatment ( p = 0.0005 ) . CONCLUSION Intravaginal electrical stimulation is effective in the alleviation of pain in women with CPP Chronic  pelvic pain ( CPP ) in women is often debilitating and isolating . Problems with diagnosis continue to make CPP one of the most perplexing conditions in gynaecology , and one of the most difficult to treat OBJECTIVES To investigate the clinical effect of electroacupuncture ( EA ) for chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) . METHODS We recruited 63 participants meeting the U.S. National Institutes of Health ( NIH ) consensus criteria for CP/CPPS . After the inclusion /exclusion criteria were applied , 39 men were r and omized to 3 treatment groups : group 1 , advice and exercise plus 12 sessions of EA ; group 2 , advice and exercise plus 12 sessions of sham EA ( SEA ) ; and group 3 , advice and exercise alone ( A&E ) for 6 weeks . A total of 6 acupuncture points were used to stimulate the sacral nerve and release the piriformis muscle using an electrical pulse generator . Symptoms related to CP/CPPS were assessed using the NIH-Chronic Prostatitis Symptom Index ( NIH-CPSI ) . Prostagl and in E(2 ) and beta-endorphin levels in postmassage urine sample s were measured using an enzyme-linked immunosorbent assay . RESULTS At 6 weeks , the NIH-CPSI total score had decreased significantly in the EA group compared with the SEA and A&E groups ( P < .001 ) . On a subscale analysis of the NIH-CPSI , the EA group showed significant decreases in pain-related symptoms compared with the SEA and A&E groups ( P < .01 ) . All 12 EA participants experienced at least a 6-point decrease in the NIH-CPSI total score compared with 2 of 12 SEA participants ( 16.7 % ) and 3 of 12 A&E participants ( 25.0 % ; P < .0001 ) . The mean prostagl and in E(2 ) level in the postmassage urine sample s had significantly decreased in the EA group ( P = .023 ) . In contrast , it had increased in the other 2 groups . CONCLUSIONS In a 3-arm r and omized trial investigating the clinical effects of EA on CP/CPPS , EA therapy proved to have independent therapeutic effects , particularly for pain relief superior to SEA or A&E therapy OBJECTIVE To assess the efficacy of intravaginal electrical stimulation ( IVES ) or placebo in women with chronic pelvic pain ( CPP ) with no apparent cause . STUDY DESIGN A double-blind , crossover , r and omized clinical trial in which 26 women were r and omly allocated to active ( group I , n = 15 ) or placebo ( group II , n = 11 ) IVES . All women underwent 10 30-minute , twice-weekly sessions . The groups were then crossed over for a further 10 sessions . Pain was evaluated using a visual analog scale ( VAS ) before and after each series . RESULTS At the end of the first series , 5 of 11 women who initiated with the placebo had a VAS pain score > 3 ( p = 0.0253 ) ; however , when they crossed over to active IVES , only 1 had a VAS pain score > 3 at the end of the series ( p = 0.0143 ) . In the 15 women who initiated with active IVES , 2 had a score > 3 at the end of the series ( p = 0.0005 ) ; however , when they crossed over to the placebo , 3 had a VAS pain score > 3 at the end of treatment ( p = 0.0833 ) . After the 2 sessions , 54.6 % who initiated with placebo and 80 % who initiated with active IVES had a VAS pain score < 3 . CONCLUSION Intravaginal electrical stimulation was more effective than a placebo in alleviating pain in women with CPP STUDY OBJECTIVE Fluid minihysteroscopy is in most cases a painless procedure . However , rarely , severe pain and side effects are reported . The goal of this study was to identify predictive factors of pain at minihysteroscopy . DESIGN Prospect i ve study ( Canadian Task Force classification II-2 ) . SETTING Academic environment . PATIENTS Five hundred thirty-three women undergoing fluid minihysteroscopy .  INTERVENTIONS Diagnostic fluid minihysteroscopy . MEASUREMENTS AND MAIN RESULTS The women were asked to score pain perception on a visual analog scale from zero ( no pain ) to 5 ( unbearable pain ) . Correlation between pain at procedure and parity , previous cesarean section ( PCS ) , menopausal status , anxiety , and chronic pelvic pain ( CPP ) was evaluated . Four hundred thirteen women ( 78 % ) reported no pain or discomfort ( 0 - 1 pain score , group A ) , while 120 ( 22 % ) experienced mild to unbearable pain ( 2 - 5 pain score , group B ) . Instances of PCS , CPP , anxiety , and menopause were significantly lower in group A than in group B ( 4 % vs 82 % , 0 % vs 29 % , 62 % vs 72 % , 25 % vs 72 % , respectively ) , whereas menopausal status was less frequent in group A ( 25.2 % ) than in group B ( 72.5 % ) . At binary logistic regression , all the variables were independent risk factors for pain ; however , when CPP was stratified for intensity , no correlation between pain at procedure and intensity of CPP was found . CONCLUSION Previous cesarean section , CPP , anxiety , and menopause are predictive factors for pain perception during fluid minihysteroscopy , and history of CPP even of low intensity is predictive of pain at hysteroscopy . These patients may benefit from local anesthesia OBJECTIVE To compare efficacy of the levonorgestrel-releasing intrauterine system ( LNG-IUS ; Mirena ) with depot GnRH analogue ( GnRH-a ; gosareline acetate ; Zoladex ) on endometriosis-related chronic pelvic pain ( CPP ) in patients with severe endometriosis during 12 months . DESIGN Prospect i ve , r and omized , controlled study . SETTING The reproductive endocrinology unit of a tertiary , research and education hospital . PATIENT(S ) Forty women with severe endometriosis ( revised The American Fertility Society [ AFS ] classification > 40 ) and endometriosis-related CPP and control groups were enrolled in the study . INTERVENTION(S ) The patients were treated with either LNG-IUS ( n = 20 ) or GnRH-a ( n = 20 ) . The GnRH-a dose was repeated every 4 weeks for 24 weeks . MAIN OUTCOME MEASURE(S ) Scores of CPP were evaluated using a visual analogue scale ( VAS ) and total endometriosis severity profile ( TESP ) . RESULT ( S ) The TESP score decreased in the LNG-IUS group at first , third , and sixth month follow-up visits , whereas at the 12th month follow-up visit , the TESP scores were increased to values similar to pretreatment values . Although the VAS score had no significant alteration during the follow-up period in the LNG-IUS group , the GnRH-a group showed a significant decrease in the VAS score and TESP score at the end of 1 year . The LNG-IUS treatment showed a lower patient satisfaction . CONCLUSION ( S ) Both treatment modalities showed comparable effectiveness in the treatment of CPP-related endometriosis Background : There are multiple approaches to the management of chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) ; and lately the data suggesting the ability of acupuncture treatment to decrease pain , positively impact quality of life and potentially modulate inflammation has suggested it as a potential therapeutic option for men with CP/CPPS . We conducted this study to determine whether acupuncture is really an effective therapeutic modality for CP/CPPS in terms of > 50 % decrease in total National Institutes of Health Chronic Prostatitis Symptom Index ( NIH-CPSI ) score from baseline compared with sham . Methods : One hundred patients with CP/CPPS ( category III B ) in an outpatient urology clinic were r and omized to receive acupuncture at either seven acupoints bilaterally or sham points adjacent to these points . NIH-CPSI was completed by each patient before and 6 , 8 , 16 , 24 weeks after the treatment . Mean values of total CPSI score and subscores after the treatment and on follow-up following the treatment were compared . Results : Of the acupuncture participants , 92 % were NIH-CPSI responders ( > 50 % decrease in total NIH-CPSI score from baseline ) compared with 48 % of sham participants , 8 weeks after the end of the therapy . Both groups experienced significant decrease in CPSI subscores throughout the whole follow-up period ; however , the decline remained significantly greater in the active acupuncture group as compared with the sham group . Conclusions : Our results show that the use of acupuncture in treatment of men with CP/CPPS symptoms result ed in a significant decrease in total NIH-CPSI scores OBJECTIVE To assess and compare the laparoscopic uterine nerve ablation ( LUNA ) and the vaginal uterosacral ligament resection ( VUSR ) in postmenopausal women with chronic pelvic pain ( CPP ) . STUDY DESIGN Eighty postmenopausal women with intractable and severe midline CPP were r and omized to undergo LUNA or VUSR .  Costs of two surgical procedures were assesses . Cure rate , severity of CPP , and deep dyspareunia were also evaluated after 6 and 12 months from surgery . RESULTS The mean cost of LUNA  result ed significantly higher in comparison with VURS ( 2078+/-637 versus 1497+/-297 , P<0.001 ) . The cure rate was not significantly different between the two groups at 6 ( 33/40 , 82.5 % versus 35/40 , 87.5 % for groups A and B , respectively ; P=0.530 ; RR 0.94 , 95 % CI 0.78 - 1.13 ) , and 12 months ( 27/36 , 75.0 % versus 28/38 , 73.7 % , for groups A and B , respectively ; P=0.901 ; RR 0.90 , 95 % CI 0.78 - 1.33 ) of follow-up . At same times , a significant ( P<0.01 ) decrease in severity of CPP and deep dyspareunia was observed in both groups with no difference between them . CONCLUSIONS Both LUNA and VUSR are equally effective surgical treatments in postmenopausal women with central CPP but VUNR is significantly cheaper than LUNA BACKGROUND The objective of this multicentre r and omized , controlled clinical trial was to compare the efficacy of a levonorgestrel-releasing intrauterine system ( LNG-IUS ) and a depot-GnRH-analogue in the control of endometriosis-related pain over a period of six months . METHODS Eighty-two women , 18 to 40 years of age ( mean 30 years ) , with endometriosis , dysmenorrhoea and /or CPP , were r and omized using a computer-generated system of sealed envelopes into either LNG-IUS ( n = 39 ) or GnRH analogue ( n = 43 ) treatment groups at three university centres . Daily scores of endometriosis-associated CPP were evaluated using the Visual Analogue Scale ( VAS ) , daily bleeding score was calculated from bleeding calendars , and improvement in quality of life was evaluated using the Psychological General Well-Being Index Question naire ( PGWBI ) . The pain score diary was based on the VAS in which women recorded the occurrence and intensity of pain on a daily basis . A monthly score was calculated from the result of the sum of the daily scores divided by the number of days in each observation period . RESULTS CPP decreased significantly from the first month throughout the six months of therapy with both forms of treatment and there was no difference between the groups ( P > 0.999 ) . In both treatment groups , women with stage III and IV endometriosis showed a more rapid improvement in the VAS pain score than women with stage I and II of the disease ( P < 0.002 ) . LNG-IUS users had a higher bleeding score than GnRH-analogue users at all time points of observation with 34 % and 71 % of patients in the LNG-IUS and GnRH-analogue groups , respectively , reporting no bleeding during the first treatment month , and 70 % and 98 % reporting no bleeding during the sixth month . No difference was observed between groups with reference to improvement in quality of life . CONCLUSIONS Both , the LNG-IUS and the GnRH-analogue were effective in the treatment of CPP-associated endometriosis , although no differences were observed between the two treatments . Among the additional advantages of the LNG-IUS is the fact that it does not provoke hypoestrogenism and that it requires only one medical intervention for its introduction every 5 years . This device could therefore become the treatment of choice for CPP-associated endometriosis in women who do not wish to conceive BACKGROUND Chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) afflicts 2%-10 % of adult men . Available therapies offer little or no proven benefit . Because acupuncture represents an attractive " natural " therapy , we compared the efficacy of acupuncture to sham acupuncture for CP/CPPS . METHODS Participants met US National Institutes of Health ( NIH ) consensus criteria for CP/CPPS , were aged > or = 20 years old , and had a total score > or = 15 on the NIH Chronic Prostatitis Symptom Index ( NIH-CPSI ) and symptoms for at least 3 of the preceding 6 months . They were r and omized 1:1 to acupuncture or sham acupuncture . Treatment consisted of twice-weekly 30-minute sessions for 10 weeks ( 20 sessions total ) without needle stimulation , herbs , or adjuvants . The primary response criterion was a 6-point decrease from baseline to week 10 in NIH-CPSI total score ( range 0 - 43 ) . RESULTS Thirty-two ( 73 % ) of 44 participants responded in the acupuncture group compared with 21 ( 47 % ) of 45 sham group participants ( relative risk 1.81 , 95 % confidence interval , 1.3 - 3.1 , P = .02 ) . Long-term responses 24 weeks after completing therapy without additional treatment occurred in 14 ( 32 % ) of 44 acupuncture group participants and in 6 ( 13 % ) of 45 sham group participants ( relative risk 2.39 , 95 % confidence interval , 1.0 - 5.6 , P = .04 ) . CONCLUSIONS After 10 weeks of treatment , acupuncture proved almost twice as likely as sham treatment to improve CP/CPPS symptoms . Participants receiving acupuncture were 2.4-fold more likely to experience long-term benefit than were participants receiving sham acupuncture OBJECTIVES CP/CPPS is a commonly observed distress in male patients . Because of its little-known etiology , no effective therapy has been developed which has promising outcomes . Therefore , there is a need to develop a valid model which can mimic the etiology of CP/CPPS . MATERIAL S AND METHODS Fifty male C57BL/6 mice were r and omly and averagely divided into 5 groups of 10 mice each . The control group was injected with 0.9 % NaCl solution . Aluminum hydroxide and T2 groups were injected with aluminum hydroxide adjuvant and T2 peptide . T2 plus complete Freund adjuvant ( CFA ) with aluminum hydroxide group was injected with a mixture of T2 , CFA and aluminum hydroxide adjuvant . At the same time , CFA group was injected with complete Freund adjuvant . Hematoxylin-eosin stain and immunohistochemistry were used to investigate inflammatory lesion and expression of IL-β1 . Furthermore , TNF-α and CRP protein levels were evaluated by using commercially available ELISA kits . The ANOVA test was used to compare the statistical differences among groups . RESULTS Prostates from a mixture of T2 plus CFA with aluminum hydroxide immunized mice showed elevated lesions and high level of inflammatory cells infiltration compared to the other groups . In addition , the levels of TNF-α , IL-β1 , and CRP were also higher in the T2 plus CFA with aluminum hydroxide group as compared to the other groups . CONCLUSION Our results showed that T2 with CFA plus aluminum hydroxide adjuvant injection could successfully induce CP/CPPS in mice . This autoimmune novel model provides a useful , economic , safer , and easy tool for exploring the etiology and pathophysiology of CP/CPPS which will improve the therapeutic outcomes OBJECTIVE Past research has shown response biases to influence the accuracy of results from self-report measures . In pain assessment , where a percentage of patients have financial and other reasons to minimize or exaggerate psychological disturbance , it becomes especially important to identify the influence of response bias in self-report of adjustment . This study investigated the susceptibility of three commonly used self-report pain assessment  measures to response bias . DESIGN This study used a within-subjects ( asymptomatic subjects ) design with two experimental conditions and nonequivalent control group ( chronic pain patients ) . SUBJECTS Experimental group : 40 students enrolled in an occupational therapy program at a major southeastern United States university . CONTROL GROUP 200 subjects referred to a multidisciplinary pain clinic at a major teaching hospital . MEASURES  Coping Strategies Question naire , Multidimensional Pain Inventory , and Pain Beliefs and Perceptions Inventory .  RESULTS With few exceptions , asymptomatic subjects scored significantly differently on these measures while portraying themselves as either coping well or coping poorly . In addition , when using the " coping poorly " response set , asymptomatic subjects reproduced scores similar to those of symptomatic chronic pain patients . CONCLUSION The susceptibility to manipulation appeared constant across the three measures , a finding that highlighted the difficulties clinicians and research ers encounter in accurate interpretation of results from these measures in the absence of validity indicators . This study also emphasizes the ease with which subjects with sufficient motivation can present themselves in an untruthful and manipulative manner and can generate scores that are , on their own , difficult to distinguish from those of a group of typical chronic pain patients OBJECTIVE There are fundamental differences between the administration of medications and the application of manual procedures , such as those used by chiropractors . The objective of this study was to gather preliminary information on how to address these differences in the design of a multisite , r and omized placebo-controlled trial of chiropractic care for women with chronic pelvic pain ( CPP ) . DESIGN Pilot study for a multisite , r and omized , placebo-controlled clinical trial . SETTING Three chiropractic research clinics in the midwest United States . SUBJECTS Thirty-nine ( 39 ) women with CPP of at least 6 months ' duration , diagnosed by board-certified gynecologists . INTERVENTIONS The active intervention consisted of the chiropractic technique , lumbar spine flexion-distraction , combined with manual Trigger Point Therapy . The placebo intervention consisted of a sham chiropractic procedure performed with an instrument combined with effleurage ( light massage ) . OUTCOME MEASURES The primary outcome measure was the change in the Pain Disability Index ( PDI ) from baseline to the end of treatment ( 6 weeks ) , assessed by group and site . If the change score was in the same direction at all sites , the results were to be combined to estimate treatment effect size . RESULTS Patient characteristics were similar to those of patients with CPP in other studies . Recruitment methods , particularly in respect to the eligibility criteria and screening protocol s , would require modification in order to recruit an adequate sample for the planned r and omized controlled trial . Clinicians followed st and ardized procedures with apparently minimal deviation , patients in both groups were satisfied with their care and blinding appeared to be successful . PDI change scores were not consistent across sites and so results were not combined and overall treatment effect sizes were not estimated . CONCLUSIONS The technical and personnel re sources required to achieve adequate st and ardization of procedures at multiple sites may make a placebo-controlled trial unfeasible , given our current lack of knowledge about the active agent in manual chiropractic procedures Chronic post-thoracotomy pain ( CPP ) is associated with surgical intercostal nerve injury . Like other forms of neuropathic pain , there is no ideal treatment . Nitroglycerin ( NTG ) has been found efficacious in acute pain , but has not been tested for chronic pain with neuropathic characteristics . The present study investigated the efficacy of NTG combined with the nonsteroidal anti-inflammatory drug etodolac for the treatment of CPP . Thirty of 129 patients who underwent thoracotomy within an 18-month period had moderate to severe pain that did not respond to etodolac . NTG , 5 mg/day , was added to the treatment . A significant reduction in VAS was observed on day 14 of treatment ( from 66.7 + /- 11 to 42.1 + /- 5 , P < 0.05 ) . Similar changes were noted in breakthrough pain intensity and and sleep efficiency . The only side effect was mild headache , which was self-limited to the first few days of NTG administration . We conclude that NTG added to etodolac appears to be effective for the treatment of CPP , with minimal side effects . Further r and omized blinded studies are required Objectives : To evaluate the efficacy and safety of Serenoa repens + selenium and lycopene ( Profluss ® ) versus S. repens alone for the treatment of category IIIa chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) . Patients and Methods : 102 patients with IIIa CP/CPPS were enrolled and r and omized into two groups each to receive Profluss or S. repens alone for 8 weeks . Evaluation was based on results of the National Institutes of Health-Chronic Prostatitis Symptom Index ( NIH-CPSI ) , IPSS , maximum peak flow rate ( MPFR ) , and PSA measurements at baseline and at weeks 4 , 8 and 8 after the end of treatment . The primary endpoint was a > 50 % reduction in NIH-CPSI score . Secondary endpoints evaluated were MPFR , IPSS , PSA and white blood cell count . Results : No patients withdrew from the study . The mean NIH-CPSI score decreased significantly ( p < 0.001 ) in both groups ; we observed a decrease in the total score from 27.45 to 13.27 in group 1 ( –51.64 % ) and from 27.76 to 20.62 in group 2 ( –26.06 % ) . IPSS improved significantly ( p < 0.001 ) in both arms , but more in group 1 . PSA and white blood cell count decreased significantly ( p < 0.007 ) only in group 1 . The MPFR improved more in group 1 ( p < 0.005 ) . Conclusion : Profluss is a triple therapy that is safe and well tolerated . It ameliorates symptoms associated with IIIa CP/CPPS Abstract Background and purpose Conditioned pain modulation ( CPM ) is a phenomenon in which pain is inhibited by heterotopic noxious stimulation . It is not known how the experimental condition affects the magnitude of the CPM response and the inter- and intra-individual variations . It is important to get the information of the test – retest reliability and inter – individual variations of CPM to apply CPM as a diagnostic tool or for screening analgesic compounds . This study evaluated ( 1 ) the magnitude of CPM , ( 2 ) the inter-individual coefficient of variation ( inter-CV ) and ( 3 ) the intra-individual coefficient of variation ( intra-CV ) to ( A ) different stimulus modalities to evoke CPM and ( B ) different assessment sites . Methods Twelve healthy men ( age 19–38 years ) participated in this study .  Cold pressor pain ( CPP ) ( immersing the h and into cold water ) , tourniquet pain ( cuff around the upper arm ) and mechanical pressure pain ( craniofacial region ) were used in r and omized order as conditioning stimuli ( CS ) . The test stimulus ( TS ) was pressure pain applied to the right masseter muscle , left forearm and leg ( bilateral tibialis anterior : TA ) . The responses were pressure pain thresholds ( PPT ) , pressure pain tolerance ( PPTol ) thresholds and the pain intensity which was assessed on a visual analogue scale ( VAS , 0–10 cm ) following 1.4 and 1.6 × PPT applied to TA . The TS was applied before , during and 10 min after the CS . The intra-individual CV was estimated between different days . Results CPP induced the most powerful CPM on PPT ( 66.3 ± 10.0 % increase ) , VAS ratings ( 41.5 ± 5.3 % reduction ) and PPTol ( 32.6±4.6 % increase ) , especially at TA , and result ed in the smallest inter-CV ( 41.4–60.1 % ) . Independently of the CS , the inter-CV in general showed that the recordings from the orofacial region and the forearm had smaller values than from the leg . The smallest intra-CV value was obtained in pain ratings with CPP ( 27.0 % ) . Conclusions This study suggests that ( 1 ) the CPP evokes the largest CPM , ( 2 ) the leg as the assessment site results in the largest CPM responses and ( 3 ) the CPP causes the smallest inter- and intra-CV . Implication The present investigation implicates that the CPP is the most efficient conditioning stimulus to induce CPM when assessed by pressure pain thresholds Objective In controlled trials of analgesics , the primary outcome variable is most often a measure of global pain intensity . However , because pain is associated with a variety of pain sensations , the effects of analgesic treatments on different sensations could go undetected if specific pain qualities are not assessed . This study sought to evaluate the utility of assessing the multiple components of non-neuropathic pain in an analgesic clinical trial . Methods A secondary analysis was performed using data from a clinical trial involving 140 individuals with low back pain who were converted from pre study opioids to an equianalgesic dose of an extended release ( ER ) formulation of oxymorphone ( OPANA ER ) , which was then titrated to a stable dose [ defined as visual analog scale ≤40 mm ( 0 to 100 mm ) on 3 of 5 consecutive days and requiring ≤2 doses rescue medication ] . Stabilized participants were then r and omly assigned to continue with either oxymorphone ER or placebo for 12 weeks . A multidimensional measure of pain quality , the Pain Quality Assessment Scale ( PQAS ) , was administered before titration , after titration , and after treatment with oxymorphone ER or placebo . Results Significant pretitration to posttitration decreases were observed in 17 of the 20 PQAS pain descriptor items and all 3 PQAS scales . The largest effects of oxymorphone ER were found on the PQAS intense , unpleasant , deep , aching , and sharp items and the PQAS Paroxysmal and Deep scales . Discussion The results indicate that oxymorphone ER has different effects on different pain qualities of low back pain . The responsivity of the PQAS items and scales to the results of treatment with an effective and generally well-tolerated dose of an analgesic , and the ability of the PQAS items and scales to discriminate between an active analgesic and placebo , support their validity as outcome measures . The findings support the utility of using pain descriptor measures for ( 1 ) identifying the effects of pain treatments on different pain qualities and ( 2 ) targeting pain treatments to those patients who experience certain types of pain INTRODUCTION Elevated body mass index ( BMI ) may predispose to several pelvic pathologies . AIMS We tested the association between BMI and five end points , namely , ( i ) erectile dysfunction ( ED ) ; ( ii ) lower urinary tract symptoms ( LUTS ) ; ( iii ) chronic prostatitis-associated pain ( CPP ) ; and ejaculatory dysfunction that is subdivided between ( iv ) pain/discomfort on ejaculation ; and ( v ) subjectively decreased ejaculate volume . METHODS Age , height , and weight were prospect ively recorded in a cohort of 590 consecutive healthy men undergoing prostate cancer screening . Continuously coded and categorized BMI ( World Health Organization classification ) were studied . MAIN OUTCOME MEASURES Age-adjusted analyses relied on logistic and linear regression models , according to data type . RESULTS The average age was 54.1 years ( range 30 - 83 ) . Of all , 296 were overweight ( 50.2 % , BMI 25 - 29.9 kg/m(2 ) ) and 85 were obese ( 14.4 % , BMI > or = 30 kg/m(2 ) ) . After age adjustment , elevated continuously coded BMI ( P < 0.001 ) and elevated categorized BMI ( P = 0.01 ) were associated with worse erectile function . Conversely , after age adjustment , elevated continuously coded BMI ( P = 0.02 ) and elevated categorized BMI ( P = 0.05 ) were associated with a lower rate of subjectively decreased ejaculate volume . Finally , after age adjustment , elevated categorically coded BMI was related to lower rates of CPP ( P < 0.001 ) and to a lower rate of pain/discomfort on ejaculation ( P = 0.03 ) . CONCLUSIONS In men undergoing prostate cancer screening , the effect of BMI on the five end points is not invariably detrimental . Elevated BMI may predispose to ED , but may also decrease the rate of pain/discomfort on ejaculation and may lower the reported rate of subjectively decreased ejaculate volume . Finally , it appeared to have no effect on LUTS OBJECTIVE To assess the efficacy and safety of duloxetine in patients with chronic fatigue syndrome . METHODS A 12-week , r and omized , double-blind study was design ed to compare duloxetine 60 - 120 mg/d  ( n = 30 )  with placebo  ( n = 30 ) for efficacy and safety in the treatment of patients with chronic fatigue syndrome . The primary outcome measure was the Multidimensional Fatigue Inventory general fatigue subscale ( range : 4 - 20 , with higher scores indicating greater fatigue ) . Secondary measures were the remaining Multidimensional Fatigue Inventory subscales , Brief Pain Inventory , Medical Outcomes Study Short Form-36 , Hospital Anxiety and Depression Scale , Centers for Disease Control and Prevention Symptom Inventory , Patient Global Impression of Improvement , and Clinical Global Impression of Severity . The primary analysis of efficacy for continuous variables was a longitudinal analysis of the intent-to-treat sample , with treatment-by-time interaction as the measure of effect . RESULTS The improvement in the Multidimensional Fatigue Inventory general fatigue scores for the duloxetine group was not significantly greater than for the placebo group ( P = 0.23 ; estimated difference between groups at week 12 = -1.0 [ 95 % CI : -2.8 , 0.7 ] ) . The duloxetine group was significantly superior to the placebo group on the Multidimensional Fatigue Inventory mental fatigue score , Brief Pain Inventory average pain severity and interference scores , Short Form-36 bodily pain domain , and Clinical Global Impression of Severity score . Duloxetine was generally well tolerated . CONCLUSION The primary efficacy measure of general fatigue did not significantly improve with duloxetine when compared with placebo . Significant improvement in secondary measures of mental fatigue , pain , and global measure of severity suggests that duloxetine may be efficacious for some chronic fatigue syndrome symptom domains , but larger controlled trials are needed to confirm these results OBJECTIVE Our purpose was to investigate the efficacy of postsurgical treatment with nafarelin in women with advanced endometriosis . STUDY DESIGN Eligible for trial were women < or = 38 years old with unexplained infertility with or without chronic pelvic pain and stage III or IV endometriosis according to the American Fertility Society , revised , classification who underwent laparotomy as first surgical treatment for debulking or radical surgery of endometriotic lesions . Patients were assigned according to a r and omization list to nasal nafarelin , 400 micrograms/day ( 36 subjects ) or placebo nasal spray ( 39 subjects ) for 3 months . Pelvic pain was assessed before first surgery and at the 12-month follow-up visit in women with pelvic pain by means of a multidimensional score system and a 10-point linear pain scale . RESULTS No marked differences in pain scores emerged among women allocated to different treatments . The mean reduction of the multidimensional score was 3.6 and 4.0 , respectively , in women allocated to nafarelin and placebo and of the 10-point linear scale scores was 7.0 and 6.9 . These differences were not statistically significant . Within 1 year from r and omization , of the 36 women allocated to nafarelin and the 39 allocated to placebo , seven ( 19 % ) and seven ( 18 % ) , respectively , became pregnant . CONCLUSION This study suggests that medical treatment with nafarelin does not markedly improve pelvic pain and short-term reproductive prognosis in women with stages III and IV endometriosis An ideal analgesic for patients after craniotomy should neither cause respiratory depression , nor affect intracranial pressure ( ICP ) and cerebral perfusion pressure ( CPP ) . The aim of the study was to evaluate the effect of Tramadol ( T ) on ICP and CPP , as well as to determine its analgetic efficacy in patients ( pts ) after craniotomy . Thirty five pts aged 16 divided by 78 years ( mean 46 ) entered the study . Twelve had GCS ( Glasgow Coma Scale ) scores < or = 8 and 23 pts had scores > or = 12 . Fourteen pts were mechanically ventilated and 21 pts were breathing spontaneously ( BS ) . Tramadol was injected i.v . at a dose of 0.75 mg/kg over 3 minutes in 11 pts ( Group 1 ) , 1.0 mg/kg over 5 minutes in 13 pts ( Group 2 ) and 1.0 mg/kg over 10 minutes in 11 pts ( Group 3 )  PaCO2  was measured before T in all pts and at 8 minute after injection in 21 BS pts . Heart rate ( HR ) , mean arterial blood pressure ( MBP ) , ICP , CPP and respiratory frequency ( f ) were registered before and in the 1st , 3rd , 8th , and 15th minute after T. Analgetic effect was evaluated in 22 conscious pts by comparing the pain intensity before and 30 minutes after T using a five-point verbal response scale . Mean control ICP was 17 mmHg . ICP over 15 mmHg was diagnosed in 15 pts ( mean ICP equal 26 mmHg ) . Mean CPP for all 35 pts was 85 mmHg . There were no statistically significant changes in HR , MBP , ICP , and CPP after T in any particular group , nor were there changes in ICP in subgroups with normal and elevated ICP . No significant changes in PaCO2 and f were found in BS pts . Satisfactory analgesia was obtained in 50 % of pts of Group 1 , and in 88 % of pts of Groups 2 and 3 . We conclude that tramadol in doses of 0.75 mg/kg and 1.0 mg/kg i.v . does not affect ICP and CPP in adult postcraniotomy patients and seems to be a safe and effective analgesic at a dose of 1.0 mg/kg for postcraniotomy pain control Background : Pain is under-detected and undertreated in people with dementia . The present study investigates the prevalence of pain in people with dementia hospitalized in nursing homes that are members of National Association of Third Age Residences ( ANASTE ) Calabria , and evaluates the association among pain , mood , and behavioral and psychological symptoms of dementia ( BPSD ) . Objective : The aim of this study is to define the prevalence of pain in people with dementia in long term care facilities using scales of self-reporting and observational tools and , particularly , to study the relationship between pain and BPSD . Methods : A prospect i ve observational study was carried out on 233 patients .  Pain assessment was performed using self-reporting tools such as the Numeric Rating Scale ( NRS ) for patients with slight cognitive impairment or no cognitive impairment and observational tools such as Pain Assessment In Advanced Dementia Scale ( PAINAD ) for patients with moderate or severe cognitive impairment . Mood was evaluated through the Cornell Scale for Depression in Dementia ( CSDD ) while behavioral problems were assessed through the Cohen-Mansfield Agitation Inventory ( CMAI ) and Neuropsychiatric Inventory ( NPI ) . Results : Only 42.5 % of patients evaluated by NRS provided a reliable answer ; of these , 20.4 % reported no pain . The percentage of pain evaluated by PAINAD was 51.8 % . Analysis of data showed a statistically significant correlation between diagnosis of pain and depressive symptoms , assessed with CSDD ( p = 0.0113 ) , as well as by single items of NPI , such as anxiety ( p = 0.0362 ) and irritability ( p = 0.0034 ) , and F1 profile ( Aggression ) of CMAI ( p = 0.01 ) . Conclusion : This study confirms that self-report alone is not sufficient to assess pain in elderly people with dementia ; the observational tool is a necessary and suitable way of assessing pain in patients with cognitive impairment . If not adequately treated , chronic pain can cause depression , agitation , and aggression in patients with dementia Brewed coffee is a widely consumed beverage , and many studies have examined its effects on human health . We investigated the vascular effects of coffee polyphenols ( CPPs ) , hypothesizing that a single ingestion of CPP during glucose loading would improve endothelial function . To test this hypothesis , we conducted a r and omized acute clinical intervention study with crossover design and measured reactive hyperemia index ( RHI ) to assess the acute effects of a 75-g glucose load with CPP in healthy , nondiabetic adult men .  Blood glucose and insulin levels were elevated after glucose loading with and without CPP , with no significant differences between treatments . The RHI did not significantly decrease after glucose loading without CPP . With CPP , however , RHI significantly ( P < .05 ) increased over baseline after glucose loading . The difference between treatments was statistically significant ( P < .05 ) . No significant changes were observed in an oxidative stress marker after glucose loading with or without CPP . These findings suggest that a single ingestion of CPP improves peripheral endothelial function after glucose loading in healthy subjects STUDY DESIGN R and omized , double-blind , placebo-controlled study . OBJECTIVES To examine the short-term therapeutic effects of monochromatic infrared energy ( MIRE ) on participants with knee osteoarthritis ( OA ) . Patients were assessed according to the International Classification of Functioning , Disability and Health . BACKGROUND MIRE is commonly used in therapy for patients with peripheral neuropathies . However , research has not focused intensively on the therapeutic effects of MIRE in patients with knee OA . METHODS This study enrolled 73 participants with knee OA . Participants received six 40-minute sessions of active or placebo MIRE treatment ( 890-nm wavelength ; power , 6.24 W ; energy density , 2.08 J/cm2/min ; total energy , 83.2 J/cm2 ) over the knee joints for 2 weeks . International Classification of Functioning , Disability and Health-related outcomes were collected weekly over 4 weeks using the Knee injury and Osteoarthritis Outcome Score , Lysholm Knee Scale , Hospital Anxiety and Depression Scale , Multidimensional Fatigue Inventory , Chronic Pain Grade question naire , World Health Organization Quality of Life-brief version , and OA Quality of Life Question naire . Data were analyzed by repeated- measures analysis of variance . RESULTS No statistically significant differences were found for the interaction of group by time for Knee injury and Osteoarthritis Outcome Score scores , including pain , other symptoms , function in daily living , function in sport and recreation , and knee-related quality of life . Scores on the Lysholm Knee Scale , Hospital Anxiety and Depression Scale , Multidimensional Fatigue Inventory , Chronic Pain Grade question naire , World Health Organization Quality of Life-brief version , and OA Quality of Life Question naire also showed no significant differences between the 2 groups at any of the 4 follow-up assessment s. CONCLUSION Short-term MIRE therapy provided no beneficial effects to body functions , activities , participation , and quality of life in patients with knee OA The purpose of this study was to assess the long-term ( six months ) effects of cognitive behavioral therapy for insomnia ( CBT-I ) in patients with chronic pain . The results of the pre-post treatment effects have been reported previously . The therapy was delivered by an advanced practice nurse in a research setting using a parallel-group , r and omized , single blind trial of CBT-I with a contact/measurement control condition . Outcomes included sleep diary , the Insomnia Severity Index , the Multidimensional Pain Inventory , the Beck Depression Inventory , the Profile of Mood States-short form , and the Pain Disability Index . Measurement time points were end-of-treatment , three-month and six-month posttherapy . Subjects receiving CBT-I ( n = 19 ) , as compared to control subjects ( n = 9 ) , did not exhibit any significant group by visit effects on measures of sleep , pain , mood , or function after end of treatment . However , subjects in the treatment group exhibited statistically ( P = 0.03 ) and clinical ly significant improvement in total sleep time ( 23 minutes ) over the six months following treatment . In this paper , cognitive behavioral therapy directed to improve insomnia was successfully delivered to patients with moderate-to-severe chronic pain and the positive effects of CBT-I continued to improve despite the presence of continued moderate-to-severe pain OBJECTIVE A study was conducted to assess a variety of treatment outcomes in long-term users of transcutaneous electrical nerve stimulation ( TENS ) who suffer from chronic pain . Key components of the study examined the effects of long-term TENS therapy on pain-related medications and physical/occupational therapy ( PT/OT ) use . DESIGN From a population of 2,(X)3 chronic pain patients ( CPPs ) who acquired a TENS device ( Epix XL , Empi , Inc. , St. Paul , MN , U.S.A. ) for pain management , a r and omly selected sample of 376 patients who used TENS  were interviewed by telephone by an independent research firm . The survey assessed a variety of outcome variables including changes in medication use , number of pain-related medications , and use of PT/OT prior to TENS and after a minimum 6 months of TENS treatment . The data were subjected to a paired t test analysis . A cost simulation model was then applied to the medication and PT/OT data . RESULTS The mean duration of pain , for which TENS was prescribed , was 40 + /- 60 months . As compared with the period prior to TENS use , this long-term TENS user group reported a statistically significant reduction in the following types of pain medications : opiate analgesics , tranquilizers , muscle relaxants , nonsteroidal anti-inflammatory drugs ( NSAIDs ) , and steroids . PT/OT use was also significantly reduced . Cost simulations of pain medications and PT/OT are presented . CONCLUSIONS Long-term use of TENS is associated with a significant reduction in the utilization of pain medication and PT/OT . In this study population , cost simulations of medication and PT/OT indicate that with long-term TENS use , costs can be reduced up to 55 % for medications and up to 69 % for PT/OT . The potential for TENS associated improvement , combined with reduced medication-related complications and costs , are important points that clinicians should consider when constructing a treatment plan for chronic pain patients . Finally , cost simulation techniques provide a useful tool for assessing outcomes in pain treatment and research This experimental study investigated the use of Snoezelen - a sensory environment purported to produce relaxation - against traditional relaxation within the pain clinic setting . The variables measured included pain , anxiety , depression , coping , self-efficacy and disability . Assessment s were carried out at three time intervals on a range of symptoms design ed to reflect the multidimensional nature of the chronic pain experience , including pain intensity and quality , anxiety , depression , coping , confidence and quality of life . The experimental group experienced significant reductions in pain ( sensory score P=0.002 ) , and an improvement in self-efficacy ( P=0.02 ) and sickness impact for the following scales : physical ( P=0.009 ) , psychosocial ( P=0.009 ) , recreation ( P=0.001 ) , sleep ( P=0.001 ) and sickness impact total ( P=0.001 ) . The control group experienced significant improvements in sickness impact scales of psychosocial ( P=0.05 ) , sleep ( P=0.01 ) and sickness impact total ( P=0.004 ) . The findings suggest that Snoezelen environments are as effective as , if not slightly better than , teaching relaxation within the traditional pain clinic environment for this group of patients Objective : To investigate the effects of a multidisciplinary back school programme ( Roessingh Back Rehabilitation Programme , RRP ) compared with usual care , as well as differences in treatment outcome between subgroups defined using two multiaxial assessment instruments : the Multidimensional Pain Inventory ( MPI-DLV ) and lumbar dynamometry . Design : R and omized controlled trial . Setting : Rehabilitation . Subjects : One hundred and sixty-three patients with chronic , aspecific low back pain . Intervention : All subjects were r and omly assigned either to a multidisciplinary , physically oriented group treatment or to their usual care . Main outcome measures : The Rol and Disability Question naire and health-related quality of life ( EuroQol , EQ5-D ) were measured as primary outcomes before r and omization and after eight weeks and six months follow-up . Result : Only 30 - 50 % of the patients in the RRP group showed improvement and this number is not significantly different from the control group . Subgroup analyses give some first indications that multiaxial measurement instruments can be used to identify subgroups with differences in treatment effects . Conclusion : The overall effect of a multidisciplinary treatment is disappointing , however multiaxial assessment before admission might be valuable in clinical practice , result ing in more effective treatments for patients with chronic low back pain Background : CPP-ACP ( Phosphopeptide-Amorphous Calcium Phosphate ) has an important role in caries prevention in pediatric patients . This study was done , because of the great use of CPP-ACP and the need for restoration for teeth treated with CPP-ACP as well as the importance of shear bond strength of adhesives in the success of restorations . Objectives : This study aim ed to evaluate the effect of casein phosphopeptide-amorphous calcium phosphate ( CPP-ACP ) on shear bond strength of dental adhesives to enamel of primary teeth molars . Material s and Methods : This in vitro study was conducted on 180 extracted primary molars . They were r and omly divided into 6 groups and each group was divided into 2 subgroups ( treated with CPP-ACP and untreated ) . In subgroups with CPP-ACP , enamel was treated with CPP-ACP paste 1 h/d for 5 days . Types of adhesives that were evaluated in this study were Tetric N-Bond , AdheSE , AdheSE One F , single Bond 2 , SE Bond , and Adper Prompt L-Pop . Shear bond strength was tested with a universal testing machine and mode of failure was evaluated under stereomicroscope . Data were analyzed by T test , 2-way analysis of variance ( ANOVA ) , Tukey and Fisher exact test using SPSS18 . P < 0.05 was considered as significance level . Results : Shear bond strengths of different adhesive systems to enamel of primary teeth treated and untreated with CPP-ACP showed no significant difference ( P > 0.05 ) . Mode of failure in all groups regardless of CPP-ACP administration was mainly adhesive type . Our results indicated that CPP-ACP did not affect shear bond strength of studied adhesives to primary teeth enamel . Conclusions : To have a successful and durable composite restoration , having a high strength bonding is essential . Considering the wide use of CPP-ACP in preventing tooth decay and the role of adhesive shear bond strength ( SBS ) in success of composite restoration , we conducted the present study to evaluate the effect of CPP-ACP on the SBS of adhesives to primary teeth enamel Purpose The aim of this longitudinal study is to determine the factors which predict a successful 1-year outcome from an intensive combined physical and psychological ( CPP ) programme in chronic low back pain ( CLBP ) patients . Methods A prospect i ve cohort of 524 selected consecutive CLBP patients was followed . Potential predictive factors included demographic characteristics , disability , pain and cognitive behavioural factors as measured at pre-treatment assessment . The primary outcome measure was the oswestry disability index ( ODI ) . A successful 1-year follow-up outcome was defined as a functional status equivalent to ‘ normal ’ and healthy population s ( ODI ≤22 ) . The 2-week residential programme fulfills the recommendations in international guidelines . For statistical analysis we divided the data base into two equal sample s. A r and om sample was used to develop a prediction model with multivariate logistic regression . The remaining cases were used to vali date this model . Results The final predictive model suggested being ‘ in employment ’ at pre-treatment [ OR 3.61 ( 95 % CI 1.80–7.26 ) ] and an initial ‘ disability score ’ [ OR 0.94 ( 95 % CI 0.92–0.97 ) ] as significant predictive factors for a successful 1-year outcome ( R2 = 22 % ; 67 % correctly classified ) . There was no predictive value from measures of psychological distress . Conclusion CLBP patients who are in work and mild to moderately disabled at the start of a CPP programme  are most likely to benefit from it and to have a successful treatment outcome . In these patients , the disability score falls to values seen in healthy population s. This small set of factors is easily identified , allowing selection for programme entry and triage to alternative treatment regimes INTRODUCTION The Multidimensional Fatigue Inventory ( MFI ) is commonly used in patients with Parkinson 's disease ( PD ) . However , most measurement properties have not been investigated in this population . The aim of this study was to investigate internal consistency , test-retest reliability , measurement error , structural validity , and floor and ceiling effects of the MFI in PD . METHODS Patients with PD ( N = 153 ) completed the MFI at baseline and week 3 in a r and omized clinical trial . Cronbach 's α , intraclass correlation coefficient ( ICC ) , and the smallest detectable change ( SDC ) were calculated . Bl and and Altman analysis was performed . Principal Component Analysis ( PCA ) was used to explore structural validity . Floor and ceiling effects were investigated . RESULTS Cronbach 's α for the MFI-total and subscales ranged from 0.74 ( reduced motivation ( RM ) ) to 0.92 ( MFI-total ) . ICC 's ranged from 0.65 ( mental fatigue ( MF ) to 0.81 ( physical fatigue ( PF ) ) , SDC ranged from 4 points ( PF and RM ) to 15 points ( MFI-total ) . Bl and and Altman analysis showed no systematic differences between assessment s. A floor effect was found for MF and ceiling effects for PF and reduced activity ( RA ) . A four-factor model was extracted , combining general fatigue ( GF ) and PF as one factor . CONCLUSIONS The MFI is reliable and valid to assess fatigue in patients with PD . Clinicians and research ers interested in assessing specific aspects of fatigue should consider interpreting GF and PF as one subscale measuring physical aspects of fatigue . To establish whether the MFI can detect meaningful changes , studies on anchor-based responsiveness and the minimal important change are needed in PD Objectives ( 1 ) To determine if treatment outcome in chronic low back pain can be predicted by a predefined multivariate prognostic model based on consistent predictors from the literature and ( 2 ) to explore the value of potentially prognostic factors further . Methods Data were derived from a r and omized controlled trial on the effect of a multidisciplinary rehabilitation program for chronic low back pain compared with usual care .  The primary outcome measure was the Rol and and Morris Disability Question naire and secondary outcomes were the Physical and Mental Component Summary Scales , derived from the Short Form Health Survey . Outcomes were expressed as the differences between baseline and follow-up ( 8 wk and 6 mo ) values . A confirmatory and an exploratory model were defined . Baseline predictors included in the confirmatory model were pain intensity , work status , and Multidimensional Pain Inventory subgroup membership . The exploratory model included sick leave , compensation , depression , and fear-avoidance beliefs . Statistical analysis was performed using multiple linear regression analysis . Results One hundred and sixty-three patients participated in the study . More pain was prognostic for more improvement in the rehabilitation group . No value was found for work status or the Multidimensional Pain Inventory subgroups . For the exploratory model , more depression and fear-avoidance beliefs predicted more improvement after rehabilitation . The explained variance ranged from 18.5 % to 43.8 % depending on the length of follow-up evaluation , the treatment group , and the outcome variable of interest . Discussion The results of this study do not support the construction of a clinical prediction model . Future confirmative studies of homogeneous rehabilitation treatments and outcome measures are needed to shed more light on relevant prognostic factors Background : Comparative responsiveness data are needed to inform choices about pain outcome measures . Objectives : To compare responsiveness of pain intensity , pain-related function , and composite measures , using data from a r and omized trial and observational study . Research Design : Analysis of responsiveness . Subjects : A total of 427 adults with persistent back , hip , or knee pain were recruited from primary care . Methods : Participants completed  Brief Pain Inventory , Chronic Pain Grade ( CPG ) , Rol and disability ,  SF-36 bodily pain  , and pain global rating of change measures . We used the global rating as the anchor for st and ardized response mean and receiver operating characteristic curve analyses . We used the distribution-based st and ard error of measurement to estimate minimally important change . To assess responsiveness to the trial intervention , we evaluated st and ardized effect size statistics stratified by trial arm . Results : All measures were responsive to global improvement and all had fair-to-good accuracy in discriminating between participants with and without improvement . SF bodily pain was less responsive than other measures in several analyses . The 3-item PEG was similarly responsive to full Brief Pain Inventory scales . CPG and SF bodily pain were less responsive to the trial intervention and did not perform well among participants with hip/knee pain . Agreement between anchor and distribution-based methods was modest . Conclusions : If a brief measure is desired , the 3-item PEG is more responsive than the SF bodily pain scale . CPG and SF bodily pain scales may be relatively poor choices for trial outcome assessment . Both anchor and distribution-based methods should be considered when determining clinical ly important change OBJECTIVE : To estimate whether botulinum toxin type A is more effective than placebo at reducing pain and pelvic floor pressure in women with chronic pelvic pain and pelvic floor muscle spasm . METHODS : This study was a double-blinded , r and omized , placebo-controlled trial . All participants presented with chronic pelvic pain of more than 2 years duration and evidence of pelvic floor muscle spasm . Thirty women had 80 units of botulinum toxin type A injected into the pelvic floor muscles , and 30 women received saline .  Dysmenorrhea , dyspareunia , dyschezia , and nonmenstrual pelvic pain were assessed by visual analog scale ( VAS ) at baseline and then monthly for 6 months . Pelvic floor pressures were measured by vaginal manometry . RESULTS : There was significant change from baseline in the botulinum toxin type A group for dyspareunia ( VAS score 66 versus 12 ; χ2=25.78 , P<.001 ) and nonmenstrual pelvic pain ( VAS score 51 versus 22 ; χ2=16.98 , P=.009 ) . In the placebo group only dyspareunia was significantly reduced from baseline ( 64 versus 27 ; χ2=2.98 , P=.043 ) . There was a significant reduction in pelvic floor pressure ( centimeters of H2O ) in the botulinum toxin type A group from baseline ( 49 versus 32 ; χ2=39.53 , P<.001 ) , with the placebo group also having lower pelvic floor muscle pressures ( 44 versus 39 ; χ2=19.85 , P=.003 ) . CONCLUSION : Objective reduction of pelvic floor spasm reduces some types of pelvic pain . Botulinum toxin type A reduces pressure in the pelvic floor muscles more than placebo . Botulinum toxin type A may be a useful agent in women with pelvic floor muscle spasm and chronic pelvic pain who do not respond to conservative physical therapy . Clinical Trial Registration : Australian Clinical Trials Registry , http://www.actr.org.au/ , ACTRN012605000515695 LEVEL OF EVIDENCE : The purpose of this study was to investigate the psychometric properties of a Dutch translation of the Multidimensional Pain Inventory , MPI-DLV . Data was available on 733 chronic pain patients . There were three issues of special interest . The first one related to the comparability between the MPI-DLV and the American and German MPI versions with regard to the psychometric aspects . The second dealt with the construct validity of the  MPI-DLV scale ' general activity ' . It was predicted that patients with high scores on this scale would be in better physical condition , as measured on a working-to-tolerance bicycle ergometer test . In relation to the third issue , attention was given to the factor-invariance between fibromyalgia patients and back pain patients . From the results obtained it was concluded that ( 1 ) the factorial structure of the three MPI parts is replicated and the reliability estimates and validity indicators are similar to those from the American and German versions ; ( 2 ) patients with high scores on the ' general activity ' scale are in better physical condition and ( 3 ) MPI-DLVs of fibromyalgia and back pain patients do have similar factorial structures . Evidence was also obtained that the  MPI-DLV  is sensitive to treatment changes . Applications of the MPI-DLV are discussed Casein phosphopeptide ( CPP ) has the potential to be added to mouth rinses , gels , toothpastes , chewing gums and confectioneries . Until now CPP has been studied in vitro , in situ and in animals , but clinical trials are lacking . This study was conducted to evaluate the efficacy of CPP-containing toothpaste in preventing dental caries in schoolchildren . The study was conducted among 150 schoolchildren r and omly divided into three groups , each using one of three types of toothpastes : ( a ) containing 2 % w/w CPP ; ( b ) containing 1,190 mg/kg fluoride as 0.76 % sodium monofluorophosphate ( SMFP ) ; ( c ) placebo toothpaste without CPP or fluoride .  Students brushed with the given toothpastes for 24 months . Oral hygiene and caries experience were assessed at baseline , 12 and 24 months . The increments in caries lesions were calculated and analyzed to assess the caries-preventive effect . A significant reduction in caries increment was observed among students using CPP toothpaste or SMFP toothpaste , compared with the group using the placebo toothpaste . The reduction in caries increment was not significantly different between the CPP and SMFP groups . Oral Hygiene Index score increased from the 12-month to the 24-month examination . It is concluded that CPP can be effectively incorporated into calcium carbonate-based toothpaste and that toothpaste containing CPP is effective in preventing caries . Toothpaste containing 2 % CPP seemed to have an efficacy similar to paste containing 1,190 mg/kg SMFP in the prevention of caries Purpose : Older adults living in long-term care experience high rates of chronic pain . Concerns with pharmacologic management have spurred alternative approaches . The purpose of this study was to examine a nursing intervention for older adults with chronic pain .  Design : This prospect i ve , r and omized control trial compared the effect of aromatherapy M technique h and massage , M technique without aromatherapy , and nurse presence on chronic pain . Chronic pain was measured with the Geriatric Multidimensional Pain and Illness Inventory factors , pain and suffering , life interference , and emotional distress and the Iowa Pain Thermometer , a pain intensity scale . Method : Three groups of 39 to 40 participants recruited from seven long-term care facilities participated twice weekly for 4 weeks . Analysis included multivariate analysis of variance and analysis of variance . Findings : Participants experienced decreased levels of chronic pain intensity . Group membership had a significant effect on the Geriatric Multidimensional Pain Inventory Pain and Suffering scores ; Iowa Pain Thermometer scores differed significantly within groups . Conclusions : M technique h and massage with or without aromatherapy significantly decreased chronic pain intensity compared to nurse presence visits . M technique h and massage is a safe , simple , but effective intervention . Caregivers using it could improve chronic pain management in this population OBJECTIVES Previous research has shown that regular use of CPP-ACP increases calcium and inorganic phosphates in plaque and reduces enamel mineral loss . The aim of this study was to investigate if a CPP-ACP-containing paste would neutralize acidic challenges in dental plaque following sucrose rinse . METHOD Plaque pH was measured on 15 subjects in a cross-over study with and without prior application of the paste and with and without CPP-ACP .  On each occasion , subjects rinsed with 10 % sucrose and sorbitol solutions for 2 min in r and omized order . RESULTS The results showed the median lowest pH without paste was 4.8 ( IQR : 4.7 - 5.0 ) and with mousse 5.6 ( IQR : 5.5 - 5.6 and p<0.001 ) . The median lowest pH was 5.0 ( IQR : 4.9 - 5.3 ) without CPP-ACP and with CPP-ACP was 5.8 ( 5.6 - 6.1 and p<0.001 ) . The time that pH remained below 5.7 and the time to return to resting pH showed similar differences in all subjects ( p<0.01 ) . CONCLUSION The results indicate that prior application of a CPP-ACP-containing paste reduced the fall in plaque pH following a sucrose challenge OBJECTIVES To determine the ability of pediatric emergency department ( ED ) nurses to accurately apply the  Ottawa Ankle Rules ( OAR ) and to evaluate whether the rate of negative ankle radiographs can be reduced by incorporating the OAR into an existing collaborative practice protocol ( CPP ) . METHODS The authors ' ED currently uses a CPP in which patients with ankle pain , swelling , deformity , or decreased range of motion on primary nursing assessment undergo radiography prior to physician evaluation . A cross-sectional study was conducted between June and November 2000 . Patients aged 5 - 19 years with an ankle injury who met at least one of the CPP criteria were eligible for enrollment . The OAR were applied by the primary nurse after initial assessment . Ankle radiographs were ordered for all enrolled patients . The interobserver variability between nurses was evaluated on a r and om sample . RESULTS One hundred ninety subjects were enrolled in the study . The  OAR  were correctly interpreted by nurses in 98.4 % of subjects . Agreement on the interobserver reliability sample was 100 % . Of the 185 subjects , 31 ( 16.8 % ) had positive radiographs . Positive OAR results were noted in 30 of 31 subjects with positive radiographs . The sensitivity of the OAR  was 97 % ( 95 % CI = 0.82 to 0.99 ) with a specificity of 25 % ( 95 % CI = 0.18 to 032 ) . Use of the OAR would have reduced the radiography rate by 21 % . CONCLUSIONS Trained nurses can accurately apply and interpret the OAR . The incorporation of the OAR into the nursing assessment of children with acute ankle injuries may reduce the number of radiographs ordered Background The  Visual Analogue Scale ( VAS ) and the Foot Health Status Question naire ( FHSQ ) are two commonly used outcome measures for evaluating foot health . This study aim ed to calculate the Minimal Important Difference ( MID ) of the VAS and the FHSQ . Methods 184 participants with plantar heel pain were recruited from the general public to take part in two r and omised trials ( 92 participants in each trial ) that studied the effectiveness of two conservative interventions for plantar heel pain . Data from these participants were used to calculate the MIDs of the  VAS and the  FHSQ .  An anchor-based method was used to calculate the MIDs . Two distinct types of pain were investigated for the VAS : average pain and first-step pain . All four domains of the FHSQ were investigated : foot pain , foot function , footwear and general foot health . Results The MID for the VAS using the anchor-based approach was -8 mm ( 95 % CI : -12 to -4 ) for average pain and -19 mm ( 95 % CI : -25 to -13 ) for first-step pain on the 100 mm VAS . The MID for the FHSQ was 13 points ( 95 % CI : 6 to 19 ) for pain and 7 points ( 95 % CI : 1 to 13 ) for function . The MID for the footwear domain of the FHSQ was -2 points ( 95 % CI : -8 to 4 ) and 0 points ( 95 % CI : -7 to 6 ) for the general foot health domain of the FHSQ . Conclusion The results of this study provide additional evidence for MID values of the VAS and the FHSQ for plantar heel pain . This is important for clinicians and research ers as it provides a greater underst and ing of how much improvement is required by a patient before a minimal , worthwhile change is experienced . The calculated MIDs will also assist research ers with prospect i ve sample size calculations PURPOSE There is limited consensus about the most appropriate measures to evaluate the adequacy of pain treatment in cancer patients . There are no known studies describing commonly used measures to simultaneously evaluate the adequacy of cancer  pain  treatment .  The purpose of this study was to compare measures , which are frequently reported in the literature , to assess the adequacy of pain treatment in cancer patients with chronic pain . This study was part of a r and omized controlled trial . PATIENTS AND METHODS In total , 313 cancer patients with a pain duration of at least 1 month were evaluated . After a baseline measure in the hospital , patients were followed up at 2 , 4 , and 8 weeks after discharge at home . Adequacy of cancer pain treatment  was evaluated by means of four different types of outcome measures . The four types included three  pain intensity markers based on patients ' pain intensity , a pain relief scale , a patient satisfaction scale , and three pain management indexes that related patients ' pain medication with pain intensity . RESULTS The proportion of inadequately treated pain patients varied extremely . Depending on the outcome measure used , the percentage of inadequately treated patients ranged from 16 % to 91 % . The choice of measure , rather than pain treatment itself , determined the proportion of inadequacy . CONCLUSION There is an urgent need for consensus about how to evaluate the effectiveness of pain treatment . Studies that evaluate adequacy of pain treatment should be interpreted with caution . Further research is necessary to eluci date the validity and reliability of outcome measures simultaneously Fichtenberg NL , Putnam SH , Mann NR , Zafonte RD , Millard AE : Insomnia screening in postacute traumatic brain injury : utility and validity of the Pittsburgh Sleep Quality Index . Am J Phys Med Rehabil 2001;80:339–345 . Objective To assess insomnia in a rehabilitation population , the authors examined the utility and validity of the Pittsburgh Sleep Quality Index ( PSQI ) . The assessment of insomnia is relevant to the treatment of traumatic brain injury at the postacute level and routine screening for insomnia may be enhanced by the availability of a st and ardized , conveniently used , self-report sleep question naire . Design The authors prospect ively studied 91 consecutive patients with traumatic brain injury who were admitted to an outpatient neurorehabilitation program . Besides administering the PSQI , Beck Depression Inventory , Epworth Sleepiness Scale  , and  Multidimensional Pain Inventory  , sleep diary and interview data were obtained and used to divide subjects into insomnia and noninsomnia groups according to the criteria established by the Diagnostic and Statistical Manual of Mental Disorders , ed 4 . Results Sensitivity and specificity rates to the clinical diagnosis of insomnia were 93 % and 100 % , respectively , for a PSQI Global Score of > 8 , and 83 % and 100 % for a diagnosis of insomnia based exclusively on PSQI-derived sleep variable data . Sleep diary data provided concurrent validity for PSQI estimates of sleep-onset latency , sleep duration , and sleep efficiency . The Beck Depression Inventory , Epworth Sleepiness Scale , and Multidimensional Pain Inventory established concurrent validity for individual PSQI items pertaining to mood , hypersomnia , and pain disturbance . Conclusion The PSQI was demonstrated to be a valid and useful screening tool for assessing insomnia among postacute patients with traumatic brain injury Objective : To evaluate the effectiveness of surface electromyographic ( EMG ) biofeedback training as a supplement to an interdisciplinary rehabilitation programme regarding consequences for activities of daily living and pain . Design : A r and omized controlled unblinded trial . Setting s : The study was carried out in a pain unit at a rehabilitation centre . Subjects : Sixty-five people with chronic whiplash-associated disorders consecutively referred to the pain unit agreed to participate in the study . Participants were r and omly assigned to either the treatment or control group . Intervention : All participants received interdisciplinary rehabilitation and the treatment group also had four weeks of surface EMG biofeedback training . Main measures : The Canadian Occupational Performance Measure was used at admission discharge and at six-month follow-up to register changes in activities of daily living . The Multidimensional Pain Inventory , Swedish version , was used at admission and at six-month follow-up to capture the multidimensional aspects of pain . Results : Sixty-two people completed the study . Both treatment and control groups improved significantly according to the Canadian Occupational Performance Measure at discharge and the results remained after six months ( P<0.001 ) . The subscale ‘ Interference ’ on the Multidimensional Pain Inventory was significantly decreased at six months for the treatment group ( P<0.001 ) . No differences were found between the two groups for activities of daily living ( performance P = 0.586 ; satisfaction P = 0.988 ) at follow-up or for pain level ( P = 0.914 ) , indicating no additional effect of the surface EMG biofeedback training . Conclusion : In this study there was no support for the effectiveness of surface EMG biofeedback training as a supplement to an interdisciplinary rehabilitation programme for people with long-lasting pain after whiplash Objective : Assess the efficacy of  duloxetine 60/120 mg ( N = 162 ) once daily compared with  placebo ( N = 168 ) in the treatment of patients with fibromyalgia , during six months of treatment . Methods : This was a phase-III , r and omized , double-blind , placebo-controlled , parallel-group study assessing the efficacy and safety of duloxetine . Results : There were no significant differences between treatment groups on the co- primary efficacy outcome measures , change in the Brief Pain Inventory ( BPI ) average pain severity from baseline to endpoint ( P = 0.053 ) and the Patient ’s Global Impressions of Improvement ( PGI-I ) at endpoint ( P = 0.073 ) . Duloxetine-treated patients improved significantly more than placebo-treated patients on the Fibromyalgia Impact Question naire pain score , BPI least pain score and average interference score , Clinical Global Impressions of Severity scale , area under the curve of pain relief , Multidimensional Fatigue Inventory mental fatigue dimension , Beck Depression Inventory-II total score , and 36-item Short Form Health Survey mental component summary and mental health score . Nausea was the most common treatment-emergent adverse event in the duloxetine group . Overall discontinuation rates were similar between groups . Conclusions : Although duloxetine 60/120 mg/day failed to demonstrate significant improvement over placebo on the co- primary outcome measures , in this supportive study , duloxetine demonstrated significant improvement compared with placebo on numerous secondary measures The Brief Pain Inventory short form ( BPI-sf ) is a vali date d , widely used , self-administered question naire developed to assess the severity of pain and the impact of pain on daily functions . A modified version was used daily in r and omised control trials of patients with arthritis undergoing treatment with cyclooxygenase-2 specific inhibitors and non-steroidal anti-inflammatory drugs .  Results indicate that the modified BPI-sf , much like the original scale , was internally reliable , consistent over time , and had good construct , as well as convergent and predictive validity in assessment of patients suffering from conditions of chronic pain . Each scale and individual pain intensity item refers to changes in osteoarthritis pain associated with medication use . The modified BPI-sf , like the parent scale , is a valid and reliable tool for situations in which pain is assessed daily and minimises the burden placed on patients to record information necessary for scientific investigations OBJECTIVE Because back pain patients often relapse within months of treatment , the effects of two types of support groups as a complement to usual medical treatment was investigated on long-term outcome . DESIGN Regular treatment was compared with an " educational " support group and a professional support group before and 1 year after intervention in a r and omized controlled trial . PATIENTS A total of 76 women and 27 men , average age of 50 years and with an accumulated sick leave for musculoskeletal pain of 2 - 24 weeks during the past year , were r and omly assigned to the three groups . OUTCOME MEASURES Sick leave records were obtained from the National Insurance Authority . A battery of st and ardized instruments was employed , which featured the Sickness Impact Profile , the Coping Strategies Question naire , the Multidimensional Pain Inventory , the Pain and Impairment Relationship Scale , the Pain and Discomfort Scale , the Pain Beliefs and Perceptions Inventory , and the Outcome Evaluation Question naire . RESULTS The Educational Support Group demonstrated greater attendance than did the Professional Support Group . However , long-term outcome was not significantly different between any of the groups for sick leave , coping , function , or experienced pain . Both support groups , relative to the Regular Treatment Group , made greater improvements on the Sickness Impact Profile . CONCLUSION This study provides little evidence that support groups , as a complement to regular treatment , enhance long-term outcome for subacute musculoskeletal pain problems . Specific treatment techniques , matched to the patient 's needs , stringently taught , and delivered in a more compact form , may be necessary for enhancing outcome Study Design . Cohort study . Objectives . To estimate the Minimal Clinical ly Important Change ( MCIC ) of the pain intensity numerical rating scale ( PI-NRS ) , the Quebec Back Pain Disability Scale ( QBPDS ) , and the Euroqol ( EQ ) in patients with low back pain . Summary of Background Data . MCIC can provide valuable information for research ers , healthcare providers , and policymakers . Methods . Data from a r and omized controlled trial with 442 patients with low back pain were used . The MCIC was estimated over a 12-week period , and three different methods were used : 1 ) mean change scores , 2 ) minimal detectable change , and 3 ) optimal cutoff point in receiver operant curves . The global perceived effect scale ( GPE ) was used as an external criterion . The effect of initial scores on the MCIC was also assessed . Results . The  MCIC of the PI-NRS ranged from 3.5 to 4.7 points in (sub)acute patients and 2.5 to 4.5 points in chronic patients with low back pain . The  MCIC of the QBPDS was estimated between 17.5 to 32.9 points and 8.5 to 24.6 points for (sub)acute and chronic patients with low back pain . The  MCIC for the EQ ranged from 0.07 to 0.58 in (sub)acute patients and 0.09 to 0.28 in patients with chronic low back pain . Conclusion . Reporting the percentage of patients who have made a MCIC adds to the interpretability of study results . We present a range of MCIC values and advocate the choice of a single MCIC value according to the specific context AIMS AND OBJECTIVES To evaluate the usefulness of  registered nurses ' ( RNs ) and nursing assistants ' ( NAs ) pain report among 304 institutional older people with dementia and eluci date the factors influencing the agreement of pain reports within dyadic assessors . BACKGROUND Using informant reports has been suggested as an effective strategy to solve the dilemma of pain assessment in people with dementia . However , the validity of pain information provided by institutional caregivers is still under-investigated . DESIGN A prospect i ve study was undertaken in six dementia special care units in Northern Taiwan . METHODS Both the four-item pain inventory and Doloplus-2 scale were used to investigate different raters ' pain reports . RESULTS Across pain variables , fair to moderate agreement was noted in RNs ' assessment ( Kappa = 0.29 - 0.42 ) , but poor agreement in NAs assessment ( Kappa = 0.11 - 0.24 ) . Comparing mean scores on intensity , frequency of pain and Doloplus-2 , statistically systematic bias existed in most pairs , but the greater bias occurred in NAs ' assessment . In logistic regression analysis , when pain was assessed by the  pain inventory  , residents ' cognitive impairment level and caregiver 's age were associated with the agreement of pain presence perceived in either resident-nurse or resident-NA pairs . Nevertheless , when pain was rated by the Doloplus-2 scale , only residents ' physical function influenced the agreement of pain report for both research assistants (RAs)-nurse and RAs-NA pairs . CONCLUSIONS Nurses ' pain report across pain variables may be more reliable than NAs . Furthermore , factors influencing the agreement of pain assessed by self-report measurement or behavioural observations may be different , needing further investigation . RELEVANCE TO CLINICAL PRACTICE Pain inquiry and behavioural observation should be performed routinely as the fifth vital sign for developing effective care plans . Institutional caregivers should be used as alternative or complementary informants for assessing pain in older people with dementia OBJECTIVE Three psychosocial profile groups are introduced in the Multidimensional Pain Inventory for chronic pain patients . Patients with the dysfunctional profile have shown a more favourable outcome after multidisciplinary treatments , due to the suggested effects of specific psychosocial treatment elements . In this study we explored , among patients with chronic low back pain , whether the Multidimensional Pain Inventory patient profile groups might respond differently to treatment without planned psychosocial elements . METHODS Of 204 voluntarily recruited patients with chronic low back pain , 102 were r and omized to a combined manipulation , exercise and physician consultation group ( called the combination group ) and 102 to a consultation-alone group .  RESULTS Although all subjects showed improvement during follow-up both on the Oswestry index and the Visual Analogue Scale , the dysfunctional profile patients in the combination group improved the most . Their high pre-treatment ratings on Oswestry and Visual Analogue-scales fell at the 5- and 12-month follow-ups to the same level as those of the adaptive copers or interpersonally distressed patients , and they were on a significantly lower level than the dysfunctional profile patients in consultation group during follow-up . All dysfunctional profile patients also showed a decrease in affective distress , equally in combination and consultation groups . CONCLUSION We suggest that dysfunctional profile patients are more sensitive to respond even to treatment without any specific psychosocial elements . This should be considered when evaluating any treatment effects . Among dysfunctional profile patients , pain-related anxiety and decreased acceptance of pain may contribute to their sensitivity to treatment We conducted a double-blind r and omized placebo-controlled study to investigate the effects of short-term 890-nm light therapy in patients with chronic low back pain in a rehabilitation clinic . Thirty-eight women and 22 men with chronic low back pain ( mean age , 60.3 years ; range , 32–80 years ) received 40-min sessions of hot-pack therapy combined with active or placebo 890-nm light therapy ( wavelength = 890 nm , radiant power output = 6.24 W , power density = 34.7 mW/cm2 for 40 min , total energy = 83.2 J/cm2 ) over the lower back three times weekly for 2 weeks . Participants were assessed before and after treatment by using a range of motion measurements , a visual analog scale evaluation of pain , the Multidimensional Fatigue Inventory , the Biodex Stability System , the Fear-Avoidance Beliefs Question naire , repeated chair-rising times , the Frenchay Activity Index , the Oswestry Disability Question naire ( ODQ ) , and the Osteoarthritis Quality of Life Question naire . The severity of disability based on the ODQ score was used as the primary clinical outcome measurement . Compared to the baseline measurements , participants in the treatment group reported significant reductions in fear-avoidance beliefs regarding physical activity ( P = 0.040 ) and work ( P = 0.007 ) and in the severity of disability ( P = 0.021 ) . Treatment with hot-pack therapy and 890-nm light therapy was associated with reductions in the severity of disability and fear avoidance beliefs in patients with chronic low back pain The present study sought to evaluate the efficacy of a 12-week multidisciplinary rehabilitation programme mainly emphasizing physiotherapy , for patients with either fibromyalgia syndrome or chronic , widespread pain . Forty-three non-r and omized female patients with fibromyalgia syndrome or chronic , widespread pain were assigned to the programme or served as waiting-list controls . The outcome was assessed with the Body Awareness Scale-Health , the Multidimensional Pain Inventory , the Quality of Life Scale , the Visual Analogue Scale and a pain drawing . Both groups were reassessed after 3 and 6 months , the treatment group also after 1 year . The treatment group improved in quality of movement and in vegetative disturbances according to the Body Awareness Scale-Health after the programme . At the 3-month and 1-year follow-ups the improvements were partly sustained . The control group showed deterioration after 3 and 6 months in three of the main scales of the Body Awareness Scale-Health . This clinical trial of a rehabilitation programme , proved beneficial for improving quality of movement and reducing the experience of vegetative disturbances OBJECTIVES To examine the efficacy of periosteal stimulation therapy ( PST , osteopuncture ) for the treatment of  chronic pain associated with advanced knee osteoarthritis . DESIGN R and omized , controlled clinical trial . SETTING Outpatient pain clinic . PARTICIPANTS Eighty-eight community-dwelling older adults with moderate knee pain or greater for 3 months or longer and Kellgren-Lawrence ( K-L ) grade 2 through 4 radiographic severity ( 80 % had K-L 4 ) . INTERVENTION Participants were r and omized to receive PST or control PST once a week for 6 weeks . MEASUREMENTS Pain severity and self-reported function ( Western Ontario and McMasters University Osteoarthritis Index ( WOMAC ) ) and physical performance ( Short Physical Performance Battery ( SPPB ) ) were assessed at baseline , after the last PST session ( post ) , and 3 months later ( follow-up ) . Pain severity was also assessed monthly using the multidimensional pain inventory short form . RESULTS Pain was reduced significantly more in the PST group than in the control PST group at post ( P=.003 ; mean WOMAC pain subscale baseline 9.4 vs 6.4 ) and 1 month later ( P<.001 ) , but by 2 months , pain levels had regressed to pre-intervention levels . The group-by-time interaction for the WOMAC function scale was significant at post ( P=.04 ) but not at follow-up ( P=.63 ) . No significant group differences were found for the SPPB . Neither analgesic use nor global improvement differed between groups . There were four treatment dropouts . CONCLUSION PST affords short-term modest pain reduction for older adults with advanced knee OA . Future research should test the effectiveness of booster treatments in sustaining analgesic benefits and of combining PST with therapeutic exercise in ameliorating disability risk Objective The objective was to evaluate whether the Multidimensional Pain Inventory ( MPI ) is effective for predicting response to interdisciplinary treatment in a heterogeneous group of patients with chronic pain . Changes in patients ' profiles to a predominantly adaptive coping status after treatment also were assessed . Design A prospect i ve study was conducted of patients with an array of pain conditions . A st and ard evaluation battery , including measures of self-reported pain and disability , psychosocial functioning , helpfulness of the program , and medication use , was used for all patients before and after treatment . The MPI status of patients was evaluated and differential response to treatment was assessed . Methods Sixty-five consecutive patients with chronic pain were evaluated before and immediately after participation in an interdisciplinary pain treatment program . This heterogeneous pain-condition cohort was also differentiated on the basis of the MPI to evaluate potential differential response to treatment . Results Results revealed significant improvement among these patients with chronic pain when a comprehensive interdisciplinary pain-management program was administered . This improvement was seen across the variety of outcomes evaluated , including narcotic medication use . Most important , the MPI subgroup classification did not significantly predict the degree of positive treatment outcome ; all subgroups improved . Conclusions Although there were major differences in psychosocial functioning before treatment , the MPI was not found to significantly predict response to interdisciplinary treatment in a heterogeneous group of patients with chronic pain . Thus , a comprehensive interdisciplinary treatment program may achieve its full effectiveness across a wide array of pain/disability-related outcome variables , regardless of initial MPI profile categorization
RESULTS The instruments most frequently used were single-item VAS and Biberoglu and Behrman pain score , while multidimensional inventories were used in few studies .
The results of clinical studies in CPP are more frequently based on one-dimensional measurements .
RATIONALE Many types of  pain assessment are available to research ers carrying out clinical trials in chronic pelvic pain ( CPP ) , ranging from a single-item scale to multidimensional inventories .
AIM Our objective was to investigate which assessment s of pain are more commonly used in clinical trials on CPP .