A comparison between chiropractic management and pain clinic management for chronic low-back pain in a national health service outpatient clinic. United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Do psychological factors predict outcome in both low-back pain and shoulder pain? Acupuncture for chronic low back pain in older patients: a randomized, controlled trial. Treatment of low back pain exacerbations with willow bark extract: a randomized double-blind study. Effectiveness of Harpagophytum procumbens in treatment of acute low back pain. 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Dry Needling of Muscle Motor Points for Chronic Low-Back Pain: A Randomized Clinical Trial With Long-Term Follow-Up Osteopathic Manipulative Treatment for Chronic Low Back Pain: A Randomized Controlled Trial A randomized double-blind pilot study comparing Doloteffin and Vioxx in the treatment of low back pain. A NEW APPROACH TO THE TREATMENT OF CHRONIC LOW BACK PAIN Low Back Pain Rating scale: validation of a tool for assessment of low back pain Minimal Clinically Important Change for Pain Intensity, Functional Status, and General Health Status in Patients With Nonspecific Low Back Pain Efficacy of electroacupuncture and tens in the rehabilitation of chronic low back pain patients Effectiveness of Harpagophytum extract WS 1531 in the treatment of exacerbation of low back pain: a randomized, placebo-controlled, double-blind study. Acupuncture for Chronic Low Back Pain: A Randomized Placebo-Controlled Study With Long-Term Follow-Up A randomized-control study of active and passive treatments for chronic low back pain following L5 laminectomy. Acupuncture treatment of chronic back pain. A double-blind placebo-controlled trial. The German multicenter, randomized, partially blinded, prospective trial of acupuncture for chronic low-back pain: a preliminary report on the rationale and design of the trial. Cost-effectiveness of Combined Manipulation, Stabilizing Exercises, and Physician Consultation Compared to Physician Consultation Alone for Chronic Low Back Pain: A Prospective Randomized Trial With 2-Year Follow-up Acupuncture analgesia for chronic low back pain.
OBJECTIVES To compare outcomes in perception of pain and disability for a group of patients suffering with chronic low-back pain ( CLBP ) when managed in a hospital by either a regional pain clinic or a chiropractor .  DESIGN The study was a pragmatic , r and omized , controlled trial . SETTING The trial was performed at a National Health Service ( NHS ) hospital outpatient clinic ( pain clinic ) in the United Kingdom . SUBJECTS AND INTERVENTIONS Patients with CLBP ( i.e. , symptom duration of > 12 weeks ) referred to a regional pain clinic ( outpatient hospital clinic ) were assessed and r and omized to either chiropractic or pain-clinic management for a period of 8 weeks . The study was pragmatic , allowing for normal treatment protocol s to be used . Treatment was administered in an NHS hospital setting . OUTCOME MEASURES The Rol and -Morris Disability Question naire ( RMDQ ) and Numerical Rating Scale were used to assess changes in perceived disability and pain . Mean values at weeks 0 , 2 , 4 , 6 , and 8 were calculated . The mean differences between week 0 and week 8 were compared across the two treatment groups using Student 's t-tests . Ninety-five percent ( 95 % ) confidence intervals ( CIs ) for the differences between groups were calculated . RESULTS R and omization placed 12 patients in the pain clinic and 18 in the chiropractic group , of which 11 and 16 , respectively , completed the trial . At 8 weeks , the mean improvement in RMDQ was 5.5 points greater for the chiropractic group ( decrease in disability by 5.9 ) than for the pain-clinic group ( 0.36 ) ( 95 % CI 2.0 points to 9.0 points ; p = 0.004 ) . Reduction in mean pain intensity at week 8 was 1.8 points greater for the chiropractic group than for the pain-clinic group ( p = 0.023 ) . CONCLUSIONS This study suggests that chiropractic management administered in an NHS setting may be effective for reducing levels of disability and perceived pain during the period of treatment for a sub population of patients with CLBP Abstract Objective To estimate the effect of adding exercise classes , spinal manipulation delivered in NHS or private premises , or manipulation followed by exercise to “ best care ” in general practice for patients consulting with back pain . Fig 1 Progress of the UK BEAM trial Design Pragmatic r and omised trial with factorial design . Setting 181 general practice s in Medical Research Council General Practice Research Framework ; 63 community setting s around 14 centres across the United Kingdom . Participants 1334 patients consulting their general practice s about low back pain . Main outcome measures Scores on the Rol and Morris disability question naire at three and 12 months , adjusted for centre and baseline scores . Results All groups improved over time . Exercise  improved mean disability question naire scores at three months by 1.4 ( 95 % confidence interval 0.6 to 2.1 ) more than “ best care . ” For manipulation the additional improvement was 1.6 ( 0.8 to 2.3 ) at three months and 1.0 ( 0.2 to 1.8 ) at 12 months . For manipulation followed by exercise the additional improvement was 1.9 ( 1.2 to 2.6 ) at three months and 1.3 ( 0.5 to 2.1 ) at 12 months . No significant differences in outcome occurred between manipulation in NHS premises and in private premises . No serious adverse events occurred . Conclusions Relative to “ best care ” in general practice , manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months ; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months ; and exercise achieved a small benefit at three months but not 12 months BACKGROUND To our knowledge , verum acupuncture has never been directly compared with sham acupuncture and guideline -based conventional therapy in patients with chronic low back pain . METHODS A patient- and observer-blinded r and omized controlled trial conducted in Germany involving 340 outpatient practice s , including 1162 patients aged 18 to 86 years ( mean + /- SD age , 50 + /- 15 years ) with a history of chronic low back pain for a mean of 8 years . Patients underwent ten 30-minute sessions , generally 2 sessions per week , of verum acupuncture ( n = 387 ) according to principles of traditional Chinese medicine ; sham acupuncture ( n = 387 ) consisting of superficial needling at nonacupuncture points ; or conventional therapy , a combination of drugs , physical therapy , and exercise ( n = 388 ) . Five additional sessions were offered to patients who had a partial response to treatment ( 10%-50 % reduction in pain intensity ) . Primary outcome was response after 6 months , defined as 33 % improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale question naire or 12 % improvement or better on the back-specific Hanover Functional Ability Question naire . Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement . RESULTS At 6 months , response rate was 47.6 % in the verum acupuncture group , 44.2 % in the sham acupuncture group , and 27.4 % in the conventional therapy group . Differences among groups were as follows : verum vs sham , 3.4 % ( 95 % confidence interval , -3.7 % to 10.3 % ; P = .39 ) ; verum vs conventional therapy , 20.2 % ( 95 % confidence interval , 13.4 % to 26.7 % ; P < .001 ) ; and sham vs conventional therapy , 16.8 % ( 95 % confidence interval , 10.1 % to 23.4 % ; P < .001 . CONCLUSIONS Low back pain improved after acupuncture treatment for at least 6 months . Effectiveness of acupuncture , either verum or sham , was almost twice that of conventional therapy Background and Objective : Psychological factors are assumed to predict persistent or recurrent musculoskeletal pain . The influence of psychological factors in patients with low-back pain ( LBP ) or shoulder pain was explored to study whether there is similarity regarding the factors that predict persisting pain and disability . Methods : Patients presenting in primary care with a new episode of shoulder pain or non-specific (sub)acute low back pain ( LBP ) were enrolled in a prospect i ve study . In both patient groups ,  pain catastrophising , distress , somatisation and fear-avoidance beliefs  were measured at baseline . Primary outcome measures at 3 months were ( 1 ) persistent symptoms , and ( 2 ) < 30 % reduction in functional disability .  Multivariate logistic regression analysis was used to study the associations between psychological factors and outcome . Results : A total of 587 patients with shoulder pain and 171 patients with LBP were enrolled in the study . In patients with shoulder pain , most associations of psychological factors with outcome were weak and not significant . Only in patients with longer symptom duration at baseline ( ⩾3 months ) were higher scores on catastrophising significantly associated with persistent symptoms ( p = 0.04 ) . In patients with LBP , psychological factors were more strongly associated with poor outcome , although most associations were not significant . Conclusion : Psychological factors , with the exception of fear-avoidance beliefs , are more strongly associated with persistent pain and disability in patients with LBP than in those with shoulder pain . This seems to indicate that in a primary care population the influence of psychological factors on outcome may vary across patients with different types of pain OBJECTIVE To determine if acupuncture is an effective , safe adjunctive treatment to st and ard therapy for chronic low back pain ( LBP ) in older patients . METHODS The inclusion criteria for subjects were : ( i ) LBP > or = 12 weeks and ( ii ) age > or = 60 yr ; the exclusion criteria were ( i ) spinal tumour , infection or fracture and ( ii ) associated neurological symptoms . The subjects were r and omized to two groups . The control group of subjects continued their usual care as directed by their physicians , i.e. NSAIDs , muscle relaxants , paracetamol and back exercises . Subjects in the acupuncture group in addition received biweekly acupuncture with electrical stimulation for 5 weeks . Outcome was measured by the modified Rol and Disability Question naire ( RDQ ) at weeks 0 , 2 , 6 and 9 . The primary outcome measure was change in RDQ score between weeks 0 and 6 . RESULTS Fifty-five patients were enrolled , with eight drop-outs . Twenty-four subjects were r and omized to the acupuncture group and 23 were r and omized to the control group . Acupuncture subjects had a significant decrease in RDQ score of 4.1 + /- 3.9 at week 6 , compared with a mean decrease of 0.7 + /- 2.8 in the control group ( P = 0.001 ) . This effect was maintained for up to 4 weeks after treatment at week 9 , with a decrease in RDQ of 3.5 + /- 4.4 from baseline , compared with 0.43 + /- 2.7 in the control group ( P = 0.007 ) . The mean global transition score was higher in the acupuncture group , 3.7 + /- 1.2 , indicating greater improvement , compared with the score in the control group , 2.5 + /- 0.9 ( P < 0.001 ) . Fewer acupuncture subjects had medication-related side-effects compared with the control group . CONCLUSIONS Acupuncture is an effective , safe adjunctive treatment for chronic LBP in older patients PURPOSE Herbal medicines are widely used for the treatment of pain , although there is not much information on their effectiveness . This study was design ed to evaluate the effectiveness of willow ( Salix ) bark extract , which is widely used in Europe , for the treatment of low back pain . SUBJECTS AND METHODS We enrolled 210 patients with an exacerbation of chronic low back pain who reported current pain of 5 or more ( out of 10 ) on a visual analog scale . They were r and omly assigned to receive an oral willow bark extract with either 120 mg ( low dose ) or 240 mg ( high dose ) of salicin , or placebo , with tramadol as the sole rescue medication , in a 4-week blinded trial . The principal outcome measure was the proportion of patients who were pain-free without tramadol for at least 5 days during the final week of the study . RESULTS The treatment and placebo groups were similar at baseline in 114 of 120 clinical features . A total of 191 patients completed the study . The numbers of pain-free patients in the last week of treatment were 27 ( 39 % ) of 65 in the group receiving high-dose extract , 15 ( 21 % ) of 67 in the group receiving low-dose extract , and 4 ( 6 % ) of 59 in the placebo group ( P < 0.001 ) . The response in the high-dose group was evident after only 1 week of treatment . Significantly more patients in the placebo group required tramadol ( P < 0.001 ) during each week of the study . One patient suffered a severe allergic reaction , perhaps to the extract . CONCLUSION Willow bark extract may be a useful and safe treatment for low back pain In a study that indicates more definitive investigation is needed , 118 patients with chronic back problems seeking treatment for acute attacks of pain were included in a 4-week r and omised double-blinded study on the safety and effectiveness of an extract of Harpagophytum procumbens . Both , the treatment and the placebo were administered in the form of two tablets taken three times per day ; the treatment group had a daily consumption equal to 6,000 mg of crude preparation ( 50 mg harpagoside , the putative active ingredient ) . The treatment and placebo groups were well matched in physical characteristics ; in the severity , duration , nature and accompaniments of their pain ; and in laboratory indices of organ system function . 109 patients completed the study . The study was originally design ed to measure Harpagophytum 's effectiveness by measuring the use of supplementary pain-killer Tramadol over its final 3 weeks . However , this did not differ between the Harpagophytum and placebo groups nor was the consumption closely related to the amount of pain . Further analysis , though , revealed that 9 out of 51 patients who received the extract were pain free at the end of treatment compared to only 1 out of 54 patients who received placebo . A modification of the Arhus index was used as an additional measure , covering the more global impact . The percentage change was greater in those patients who received Harpagophytum extract than in those who received placebo , but inferential testing ( Mann Whitney ) allowed only 94 % degree of confidence that this had not arisen by chance . The Arhus index reduction was based on improvement in pain . This indication of effectiveness , and the absence of demonstrable adverse effects show that more definite clinical studies of Harpagophytum extract will be worthwhile Abstract Practice guidelines recommend various types of exercise and manipulative therapy for chronic back pain but there have been few head‐to‐head comparisons of these interventions . We conducted a r and omized controlled trial to compare effects of general exercise , motor control exercise and manipulative therapy on function and perceived effect of intervention in patients with chronic back pain . Two hundred and forty adults with non‐specific low back pain ⩾3 months were allocated to groups that received 8 weeks of general exercise , motor control exercise or spinal manipulative therapy . General exercise included strengthening , stretching and aerobic exercises . Motor control exercise involved retraining specific trunk muscles using ultrasound feedback . Spinal manipulative therapy included joint mobilization and manipulation . Primary outcomes were patient‐specific function ( PSFS , 3–30 ) and global perceived effect ( GPE , −5 to 5 ) at 8 weeks . These outcomes were also measured at 6 and 12 months . Follow‐up was 93 % at 8 weeks and 88 % at 6 and 12 months . The motor control exercise group had slightly better outcomes than the general exercise group at 8 weeks ( between‐group difference : PSFS 2.9 , 95 % CI : 0.9–4.8 ; GPE 1.7 , 95 % CI : 0.9–2.4 ) , as did the spinal manipulative therapy group ( PSFS 2.3 , 95 % CI : 0.4–4.2 ; GPE 1.2 , 95 % CI : 0.4–2.0 ) . The groups had similar outcomes at 6 and 12 months . Motor control exercise and spinal manipulative therapy produce slightly better short‐term function and perceptions of effect than general exercise , but not better medium or long‐term effects , in patients with chronic non‐specific back pain Study Design . A r and omized controlled clinical trial was conducted . Objective . To compare medication , needle acupuncture , and spinal manipulation for managing chronic ( > 13 weeks duration ) spinal pain because the value of medicinal and popular forms of alternative care for chronic spinal pain syndromes is uncertain . Summary of Background Data . Between February 1999 and October 2001 , 115 patients without contraindication for the three treatment regimens were enrolled at the public hospital ’s multidisciplinary spinal pain unit . Methods . One of three separate intervention protocol s was used : medication , needle acupuncture , or chiropractic spinal manipulation . Patients were assessed before treatment by a sports medical physician for exclusion criteria and by a research assistant using the Oswestry Back Pain Disability Index ( Oswestry ) , the Neck Disability Index ( NDI ) , the Short-Form-36 Health Survey question naire ( SF-36 ) , visual analog scales ( VAS ) of pain intensity and ranges of movement . These instruments were administered again at 2 , 5 , and 9 weeks after the beginning of treatment . Results . R and omization proved to be successful . The highest proportion of early ( asymptomatic status ) recovery was found for manipulation ( 27.3 % ) , followed by acupuncture ( 9.4 % ) and medication ( 5 % ) . Manipulation achieved the best overall results , with improvements of 50 % ( P = 0.01 ) on the Oswestry scale , 38 % ( P = 0.08 ) on the NDI , 47 % ( P < 0.001 ) on the SF-36 , and 50 % ( P < 0.01 ) on the VAS for back pain , 38 % ( P < 0.001 ) for lumbar st and ing flexion , 20 % ( P < 0.001 ) for lumbar sitting flexion , 25 % ( P = 0.1 ) for cervical sitting flexion , and 18 % ( P = 0.02 ) for cervical sitting extension . However , on the VAS for neck pain , acupuncture showed a better result than manipulation ( 50%vs 42 % ) . Conclusions . The consistency of the results provides , despite some discussed shortcomings of this study , evidence that in patients with chronic spinal pain , manipulation , if not contraindicated , results in greater short-term improvement than acupuncture or medication . However , the data do not strongly support the use of only manipulation , only acupuncture , or only nonsteroidal antiinflammatory drugs for the treatment of chronic spinal pain . The results from this exploratory study need confirmation from future larger studies Study Design . Prospect i ve study with 6 weeks of follow-up . Objective . To examine the predictors of outcome for patients with (sub)acute low back pain ( LBP ) receiving usual care ( UC ) or a minimal intervention strategy ( MIS )  aim ed at psychosocial factors . Summary of Background Data . A r and omized controlled trial in general practice showed no differences in average effect between UC and MIS . Methods . Socio-demographic variables , characteristics of LBP , and psychosocial factors were included as potential predictors of outcome . The outcome clinical ly important improvement was defined as a reduction of at least 30 % on functional disability plus patient perceived recovery . Logistic regression analyses were used to study the associations between predictors and outcome at 6 weeks follow-up . Results . In the  UC group ( n = 163 ) , the multivariable model included a shorter duration of the LBP episode , few previous episodes , less pain catastrophizing , and good perceived general health . The area under the curve ( AUC ) of the model was 0.77 ( 95 % confidence interval , 0.70–0.85 ) . In the  MIS group ( n = 142 ) , the multivariable model included less somatizing symptoms , more solicitous responses by an important other , lower perceived risk for chronic LBP , more fear avoidance beliefs , higher level of education , and shorter duration of the LBP episode . This AUC was 0.78 ( 95 % confidence interval , 0.71–0.86 ) . Conclusions . As we found two different profiles , our approach may contribute to the important question : what intervention works for whom A controlled study of different modes of acupuncture stimulation was conducted on patients fulfilling clinical criteria for chronic low back pain of nociceptive origin . Forty patients were r and omly entered into the study . Thirty had three trial treatments with manual stimulation of needles ( MS ) , electrical low frequency stimulation at 2 Hz ( LF ) , and high – frequency stimulation at 80 Hz ( HF ) , and then continued treatment with the mode they felt most benefitted them . Ten patients were put on the waiting list for treatment but served as the untreated control group . The results were evaluated after 6 weeks and at 6 months for : activity related to pain ; mobility ; verbal descriptors of pain and the patient 's subjective assessment of his condition . After 6 weeks , patients receiving treatment showed significant improvement ( P < 0.05 to P < 0.001 ) on three of the four measures compared to the untreated controls . After 6 months a similar measure of significant improvement was seen in patients continuing with low – frequency ( LF ) acupuncture , but not in those groups continuing with manual stimulation ( MS ) or high – frequency ( HF ) acupunture . The results suggest that 2 Hz electrical stimulation is the mode of choice when using acupuncture in the treatment of chronic nociceptive low back pain BACKGROUND Acupuncture is widely used by patients with low back pain , although its effectiveness is unclear . We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain .  METHODS Patients were r and omized to treatment with acupuncture , minimal acupuncture ( superficial needling at nonacupuncture points ) , or a waiting list control . Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers , and consisted of 12 sessions per patient over 8 weeks . Patients completed st and ardized question naires at baseline and at 8 , 26 , and 52 weeks after r and omization . The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8 , as determined on a visual analog scale ( range , 0 - 100 mm ) . RESULTS A total of 298 patients ( 67.8 % female ; mean + /- SD age , 59 + /- 9 years ) were included . Between baseline and week 8 , pain intensity decreased by a mean + /- SD of 28.7 + /- 30.3 mm in the acupuncture group , 23.6 + /- 31.0 mm in the minimal acupuncture group , and 6.9 + /- 22.0 mm in the waiting list group . The difference for the acupuncture vs minimal acupuncture group was 5.1 mm ( 95 % confidence interval , -3.7 to 13.9 mm ; P = .26 ) , and the difference for the acupuncture vs waiting list group was 21.7 mm ( 95 % confidence interval , 13.9 - 30.0 mm ; P<.001 ) . Also , at 26 ( P=.96 ) and 52 ( P=.61 ) weeks , pain did not differ significantly between the acupuncture and the minimal acupuncture groups . CONCLUSION Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain , whereas there were no significant differences between acupuncture and minimal acupuncture Study Design . R and omized , single blind , controlled trial . Objective . To determine the efficacy of 2 components of musculoskeletal physiotherapy on chronic low back disorder . Summary of Background Data . Musculoskeletal physiotherapy encompasses many treatment methods , however , manual therapy and exercises to rehabilitate spinal stabilization are the most frequently used . Despite their popularity , scant evidence supports their use on subjects with chronic low back disorder . Methods . A total of 346 subjects were r and omized to manual therapy , a 10-week spinal stabilization rehabilitation program , or a minimal intervention control group . Data were collected at baseline , and 3 , 6 , 12 , and 24 months after intervention . Outcome measures recorded intensity of low back pain , disability , h and icap , medication , and quality of life . There were 4 main variables combined in a primary component analysis to form a single outcome measure ( i.e. , a measure of dysfunction ) . Results . The results indicated statistically significant improvements in favor of the spinal stabilization group at the 6-month stage in pain ( 65.9 % reduction in symptoms ) and dysfunction ( combined mean reduction of 134 , st and ard error 23.84 ) , and at the 1-year stage in medication ( 34.3 % reduction in medication ) , dysfunction ( combined mean reduction of 134 , st and ard error 18.2 ) , and disability ( mean difference in change 15.71 Oswestry Disability Index , 95 % confidence interval 19.3–10.01 ) . Conclusions . As a component of musculoskeletal physiotherapy , the spinal stabilization program is more effective than manually applied therapy or an education booklet in treating chronic low back disorder over time . Both manual therapy and the spinal stabilization program are significantly effective in pain reduction in comparison to an active control . To our knowledge and up until now , this result has not been shown in patients with chronic low back disorder In a r and omized controlled trial plus a nonr and omized cohort , the authors investigated the effectiveness and costs of acupuncture in addition to routine care in the treatment of chronic low back pain and assessed whether the effects of acupuncture differed in r and omized and nonr and omized patients . In 2001 , German patients with chronic low back pain were allocated to an acupuncture group or a no-acupuncture control group .  Persons who did not consent to r and omization were included in a nonr and omized acupuncture group . All patients were allowed to receive routine medical care in addition to study treatment .  Back function ( Hannover Functional Ability Question naire ) , pain , and quality of life were assessed at baseline and after 3 and 6 months , and cost-effectiveness was analyzed . Of 11,630 patients ( mean age=52.9 years ( st and ard deviation , 13.7 ) ; 59 % female ) , 1,549 were r and omized to the acupuncture group and 1,544 to the control group ; 8,537 were included in the nonr and omized acupuncture group . At 3 months , back function improved by 12.1 ( st and ard error ( SE ) , 0.4 ) to 74.5 ( SE , 0.4 ) points in the acupuncture group and by 2.7 ( SE , 0.4 ) to 65.1 ( SE , 0.4 ) points among controls ( difference=9.4 points ( 95 % confidence interval 8.3 , 10.5 ) ; p<0.001 ) . Nonr and omized patients had more severe symptoms at baseline and showed improvements in back function similar to those seen in r and omized patients . The incremental cost-effectiveness ratio was euro10,526 ( euros ) per quality -adjusted life year . Acupuncture plus routine care was associated with marked clinical improvements in these patients and was relatively cost-effective Study Design . An observational prospect i ve cohort study in general practice . Objectives . To describe the clinical course and to identify predictors of recovery , changes in pain intensity , and changes in functional disability in patients with neck or shoulder symptoms at 3- and 12-month follow-up . Summary of Background Data . Knowledge on the clinical course and predictors of outcome in neck and shoulder symptoms is limited . Such knowledge would facilitate treatment decisions and may help to inform patients about their prognosis . Methods . Four hundred and forty-three patients who consulted their general practitioner with neck or shoulder symptoms participated in the study . Baseline scores of pain and disability , symptom characteristics , sociodemographic and psychological factors , social support , physical activity , general health , and comorbidity were investigated as possible predictors of recovery , changes in pain intensity , and changes in functional disability using multiple regression analyses . Results . The recovery rate was low ; 24 % of the patients reported recovery at 3 months and 32 % reported recovery at 12-month follow-up . Duration of the symptoms before consulting the GP and a history of neck or shoulder symptoms increased the probability of an unfavorable outcome . Furthermore , less vitality and more worrying were consistently associated with poorer outcome after 3 and 12 months . The area under the receiver-operator characteristic curve for the model predicting recovery was 0.8 at 3 months and 0.75 at 12 months . The explained variance of the models on pain and functional disability ranged from 43 to 54 % . Conclusions . The results found in this study indicate that besides clinical characteristics , psychological factors also predict the outcome of neck and shoulder symptoms OBJECTIVE To investigate the course of lateral epicondylitis and identify prognostic indicators associated with short- and longterm outcome of pain intensity . METHODS We prospect ively followed patients ( n = 349 ) from 2 r and omized controlled trials investigating conservative interventions for lateral epicondylitis in primary care .  Uni- and multivariate linear regression analyses were used to investigate the association between potential prognostic indicators and pain intensity ( 0 - 100 point scale ) measured at 1 , 6 , and 12 months after r and omization . Potential prognostic factors were duration of elbow complaints , concomitant neck pain , concomitant shoulder pain , previous elbow complaints , baseline pain scores , age , gender , involvement of dominant side , social class , and work status . The variables " study " and " treatment " were included as covariates in all models . RESULTS Pain scores at 1 month followup were higher in patients with severe pain  , a long duration of elbow complaints , and concomitant shoulder pain .  At 12 month followup , the only different prognostic indicator for poor outcome was concomitant neck pain , in place of shoulder pain . Patients from higher social classes reported lower pain scores at 12 month followup than patients from lower social classes . CONCLUSIONS Lateral epicondylitis seems to be a self-limiting condition in most patients . Long duration of elbow complaints , concomitant neck pain , and severe pain at presentation are associated with poor outcome at 12 months . Our results will help care providers give patients accurate information regarding their prognosis and assist in medical decision-making & NA ; There is some evidence for the efficacy of acupuncture in chronic low‐back pain ( LBP ) , but it remains unclear whether acupuncture is superior to placebo . In a r and omized , blinded , placebo‐controlled trial , we evaluated the effect of traditional acupuncture in chronic LBP . A total of 131 consecutive out‐ patients of the Department of Orthopaedics , University Goettingen , Germany , ( age=48.1 years , 58.5 % female , duration of pain : 9.6 years ) with non‐radiating LBP for at least 6 months and a normal neurological examination were r and omized to one of three groups over 12 weeks . Each group received active physiotherapy over 12 weeks . The control group ( n=46 ) received no further treatment , the acupuncture group ( n=40 ) received 20 sessions of traditional acupuncture and the sham‐acupuncture group ( n=45 ) 20 sessions of minimal acupuncture . Changes from baseline to the end of treatment and to 9‐month follow‐up were assessed in pain intensity and in pain disability , and secondary in psychological distress and in spine flexion , compared by intervention groups . Acupuncture was superior to the control condition ( physiotherapy ) regarding pain intensity ( P=0.000 ) , pain disability ( P=0.000 ) , and psychological distress ( P=0.020 ) at the end of treatment . Compared to sham‐acupuncture , acupuncture reduced psychological distress ( P=0.040 ) only . At 9‐month follow‐up , the superiority of acupuncture compared to the control condition became less and acupuncture was not different to sham‐acupuncture . We found a significant improvement by traditional acupuncture in chronic LBP compared to routine care ( physiotherapy ) but not compared to sham‐acupuncture . The trial demonstrated a placebo effect of traditional acupuncture in chronic LBP OBJECTIVES To compare the effects of a proprietary extract of willow bark ( Assalix ) and a selective inhibitor ( rofecoxib ) of the enzyme cyclo-oxygenase-2 ( COX-2 ) . METHODS An open , r and omized , post-marketing study was carried out in an out- patients clinic on two groups of patients aged 18 to 80 yr presenting over a 6-month period with acute exacerbations of low back pain . Using computer-generated r and om list , 114 patients were allocated to receive a daily dose of herbal extract containing 240 mg of salicin [ PAID ( phyto-anti-inflammatory drug ) group ] and 114 were allocated to receive 12.5 mg of the synthetic COX-2 inhibitor rofecoxib [ NSAID ( non-steroidal anti-inflammatory drug ) group ] . The doses were chosen according to existing recommendations . All patients were free to use whatever additional conventional treatments were thought necessary . The outcome measures were a modified Arhus index , its pain component and the Total Pain Index . RESULTS Groups were well matched . After 4 weeks of treatment , the Arhus index had improved by about 20 % , its pain component by about 30 % and the Total Pain Index by about 35 % . The number of pain-free patients ( visual analogue scale score < 2 ) was about 20 in each group . About 60 % of the patients in each group responded well to the treatment ( as judged by an improvement of > /=30 % in the Total Pain Index relative to its baseline ) . The improvement was also reflected reasonably well in the physicians ' and patients ' judgements of the effectiveness of treatment , which were largely concordant . Few patients of either group resorted to the additional conventional treatment options . The incidence of adverse events was similar in the two groups . Treatment with rofecoxib was about 40 % more expensive than that with Assalix . CONCLUSION There was no significant difference in effectiveness between the two treatments at the doses chosen . Treatment with Assalix was less expensive OBJECTIVE To assess the long-term benefits of medication , needle acupuncture , and spinal manipulation as exclusive and st and ardized treatment regimens in patients with chronic ( > 13 weeks ) spinal pain syndromes . STUDY DESIGN Extended follow-up ( > 1 year ) of a r and omized clinical trial was conducted at the multidisciplinary spinal pain unit of Townsville 's General Hospital between February 1999 and October 2001 . PATIENTS AND METHODS Of the 115 patients originally r and omized , 69 had exclusively been treated with the r and omly allocated treatment during the 9-week treatment period ( results at 9 weeks were reported earlier ) . These patients were followed up and assessed again 1 year after inception into the study reapplying the same instruments ( ie , Oswestry Back Pain Index , Neck Disability Index , Short-Form-36 , and Visual Analogue Scales ) . Question naires were obtained from 62 patients reflecting a retention proportion of 90 % . The main analysis was restricted to 40 patients who had received exclusively the r and omly allocated treatment for the whole observation period since r and omization . RESULTS Comparisons of initial and extended follow-up question naires to assess absolute efficacy showed that only the application of spinal manipulation revealed broad-based long-term benefit : 5 of the 7 main outcome measures showed significant improvements compared with only 1 item in each of the acupuncture and the medication groups . CONCLUSIONS In patients with chronic spinal pain syndromes , spinal manipulation , if not contraindicated , may be the only treatment modality of the assessed regimens that provides broad and significant long-term benefit Background Previous clinical trials have assessed the percentage of participants who utilized further health care after a period of conservative care for low back pain , however no chiropractic clinical trial has determined the total amount of care during this time and any differences based on assigned treatment group . The objective of this clinical trial follow-up was to assess if there was a difference in the total number of office visits for low back pain over one year after a four week clinical trial of either a form of physical therapy ( Exercise Program ) or a form of chiropractic care ( Flexion Distraction ) for chronic low back pain . Methods In this r and omized clinical trial follow up study , 195 participants were followed for one year after a four-week period of either a form of chiropractic care ( FD ) or a form of physical therapy ( EP ) . Weekly  structured telephone interview questions  regarded visitation of various health care practitioners and the practice of self-care for low back pain . Results Participants in the physical therapy group demonstrated on average significantly more visits to any health care provider and to a general practitioner during the year after trial care ( p < 0.05 ) . No group differences were noted in the number of visits to a chiropractor or physical therapist . Self-care was initiated by nearly every participant in both groups . Conclusion During a one-year follow-up , participants previously r and omized to physical therapy attended significantly more health care visits than those participants who received chiropractic care The acupuncture treatment situation was beneficial to the majority of people with low back pain .  This was shown by the use of short-term controls and long-term controls , although the latter were not intended in the study design . After acupuncture , there was a 51 % pain reduction in the average pain score in the Immediate Treatment Group . The short-term controls , the Delayed Treatment Group , had no reduction whatsoever in their pain scores at the comparable followup period . Later , the Delayed Treatment Group bere also treated by acupuncturists , and reported 62 % less pain . When these two treatment groups were compared at 40 weeks with long-term controls ( Inadequate Treatment Group ) , the Inadequate Treatment Group still had the same pain scores , on the average , as when they enrolled in the study . Both treatment groups , on the average , had 30 % lower pain scores . Furthermore , 58 % of the treatment groups felt that they were definitely improved at 40 weeks , while only 11 % of the Inadequate Treatment Group felt definitely improved at 40 weeks & NA ; The efficacy and tolerance of a capsicum plaster in non‐specific low back pain was investigated in a double‐blind , r and omised , placebo‐controlled multicentre parallel group study . A total of 320 patients were r and omly assigned to two groups of n=160 subjects treated by the active or the placebo plaster . The main outcome measures used were a compound pain subscore of the Arhus low back rating scale ( continuous variable ) , and a response criterion of a reduction in pain subscore=30 % from baseline to final assessment ( secondary , non‐continuous variable ) . In addition , the partial pain scores , disability and mobility restriction subscores , the total score of the Arhus low back rating scale , the global evaluation of efficacy by investigator and patient , adverse events , a patient question naire on use of the plaster , and an evaluation of tolerance by investigator and patient were obtained . After 3 weeks treatment with capsicum and placebo plaster respectively , the compound pain subscore was reduced by 42 % ( capsicum ) and 31 % ( placebo ) from values on entry . Responder rate was 67 % versus 49 % ( p=0.002 ) . The investigators rated efficacy as “ excellent ” or “ good ” by 74 % and 36 % ; the patient 's efficacy rating “ symptomfree ” or “ improved ” reached 82 % and 50 % . Adverse local drug reactions were found in 12 patients ( 7.5 % ) on capsicum and 5 ( 3.1 % ) on  placebo . No systemic side‐effects were observed . The superiority of the treatment of chronic non‐specific low back pain  with capsicum plaster compared to placebo was clinical ly relevant and highly statistically significant . The capsicum plaster offers a genuine alternative in the treatment of non‐specific low back pain Acupuncture is an established adjuvant analgesic modality for the treatment of chronic pain .  Electrical stimulation of acupuncture points is considered to increase acupuncture analgesia . In this prospect i ve , r and omized , double-blind , controlled study we tested the hypothesis that auricular electroacupuncture ( EA )  relieves pain more effectively than conventional manual auricular acupuncture ( CO ) in chronic low back pain patients with insufficient pain relief ( visual analogue scale [ VAS ] ≥5 ) treated with st and ardized analgesic therapy . Disposable acupuncture needles were inserted in the auricular acupuncture points 29 , 40 , and 55 of the dominant side and connected to a newly developed battery-powered miniaturized stimulator worn behind the ear . Patients were r and omized into group EA ( n = 31 ) with continuous low-frequency auricular EA ( 1 Hz biphasic constant current of 2 mA ) and group CO ( n = 30 ) without electrical stimulation ( sham-electroacupuncture ) . Treatment was performed once weekly for 6 wk , and in each group needles were withdrawn 48 h after insertion . During the study period and a 3-mo follow-up , patients were asked to complete the McGill question naire . Psychological well being , activity level , quality of sleep , and pain intensity were assessed by means of VAS ; moreover , analgesic drug consumption was documented . Pain relief was significantly better in group EA during the study and the follow-up period as compared with group CO . Similarly , psychological well-being , activity , and sleep were significantly improved in group EA versus group CO , the consumption of analgesic rescue medication was less , and more patients returned to full-time employment . Neuropathic pain in particular improved in patients treated with EA . There were no adverse side effects . These results are the first to demonstrate that continuous EA stimulation of auricular acupuncture points improves the treatment of chronic low back pain in an outpatient population Topically applied capsaicin ( CAS 404 - 86 - 4 ) induces the release of substance P , a neurotransmitter , from sensory C-fibres . In addition , there is a specific blockade of transport and de-novo synthesis of substance P. As a result , repeated applications of capsaicin bring about a long lasting desensitisation to pain ( increase of pain threshold ) . The desensitising effect is fully reversible . The confirmed pharmacodynamic actions and a number of double-blind clinical studies indicate that local capsicum preparations are very suitable for the treatment of neuropathic pain or musculoskeletal disorders , with or without inflammatory components . In a double-blind , r and omised parallel-group study a capsicum plaster was compared with a placebo for 3 weeks in 154 patients with non-specific back pain . Inclusion criteria were a history of back pain for a minimum period of 3 months and a degree of pain of 5 or more on an eleven grade visual analogue scale . The principal target variable consisted of the score of 3 combined pain scales . Secondary efficacy measures were tests of mobility , a disability index ( in the context of Arhus low back rating scale ) and global assessment s by physicians and patients . For patients to be rated as responders their total pain score at the final examination after 3 weeks of treatment had to show a reduction by at least 30 % of the baseline value . The study unequivocally achieved the target criterion with a rate of responders in the capsicum group of 60.8 % against 42.1 % in the placebo group ( p = 0.0219 ) . The sum of the 3 separate pain scales decreased more markedly in the capsicum group than in the placebo group ( 38.5 % compared to 28.0 % ; p = 0.002 ) . Relatively slight improvements of the impaired mobility and the functional status are explained by the characteristics of the disorder treated . The efficacy ratings by observers and patients was definitely in favour of capsicum .  Adverse effects -- mostly harmless and resolving spontaneously -- were reported by 15 patients in the capsicum group and by 9 in the placebo group . The tolerance ratings by investigators and patients were superior to the placebo product . This , however , partly is due to the local pharmacological actions of the drug . As in comparably positive r and omised studies with capsaicin cream in patients with osteoarthritis or fibromyalgia it was shown that a capsicum plaster preparation can also be used to advantage in chronic non-specific back pain Abstract Shoulder pain is common in primary care and has an unfavourable outcome in many patients . Information about predictors of outcome is scarce and inconsistent . The objective of this study was to develop clinical prediction rules for calculating the absolute risk of persistent shoulder symptoms for individual patients , 6 weeks and 6 month after the first consultation in general practice . A prospect i ve cohort study with 6 months follow‐up was carried out in three geographic areas in The Netherl and s. In this study , 587 patients with a new episode of shoulder pain were included . The main outcome measure was persistent symptoms at 6 weeks and 6 months , perceived by the patient . Potential predictors included the results of a physical examination , sociodemographic variables , disease characteristics ( duration of symptoms , pain intensity , disability and comorbidity ) , physical activity , physical workload and psychosocial factors . Response rates to the follow‐up question naires were 83 % at 6 weeks and 92 % at 6 months . A longer duration of symptoms , gradual onset of pain and high pain severity at presentation were consistently associated with persistent symptoms at 6 weeks and 6 months . The discriminative validity of our prediction rules was satisfactory with area under the curves of 0.74 ( 95 % CI 0.70 , 0.79 ) at 6 weeks and 0.67 ( 95 % CI 0.63 , 0.71 ) at 6 months . The performance of our rules needs to be tested in other population s of patients with shoulder pain to enable valid and reliable use of the rules in everyday clinical practice Objective To assess the efficacy of acupuncture in the treatment of chronic low back pain .  Methods Patients ( n = 60 ) with chronic low back pain were recruited and r and omly allocated to either Acupuncture therapy or Placebo transcutaneous electrical nerve stimulation ( TENS ) groups . Patients were treated weekly for 6 weeks , and blinded assessment s were carried out pre- and post-treatment using the McGill Pain Question naire ( MPQ ) and visual analog scales ( VAS ) for pain , the Short-form 36 quality -of-life question naire , and a simple range of motion measurement .  A total of 46 patients completed the trial and were followed up at 6 months . Results Analysis of results using t tests showed that in both groups there were significant pre-post improvements for all scores , except for MPQ scores in the Placebo-TENS group . There was no significant difference between the 2 groups for any of the outcome measures at the end of treatment . Results from the 6-month follow-up would suggest that the response was better in the acupuncture group . Discussion Further research is necessary to fully assess the efficacy of this treatment in combating chronic low back pain using larger sample sizes or alternative control groups Background : We report on the study design and protocol s of two r and omized controlled trials ( Acupuncture R and omized Trials = ART ) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee , respectively . Objective : To investigate whether acupuncture is more efficacious than ( a ) no treatment or ( b ) minimal acupuncture in the treatment of low back pain and osteoarthritis . Design : Two r and omized , controlled , multicenter trials with three treatment arms and a total follow-up time of 52 weeks . Setting : 30 practitioners and outpatient units in Germany specialized in acupuncture treatment . Patients : 300 patients will be included in each study . In the low back pain trial , patients will be included according to clinical diagnosis . In the osteoarthritis pain trial , patients will be included according to the American College of Rheumatology criteria . Interventions : Patients are r and omly assigned to receive either ( 1 ) semi-st and ardized acupuncture ( 150 patients ) , ( 2 ) minimal acupuncture at non-acupuncture points ( 75 patients ) , or ( 3 ) no treatment for two months followed by semi-st and ardized acupuncture ( 75 patients , waiting list control ) . Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks . Main Outcome Measure : The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters : pain intensity as measured by a visual analogue scale ( VAS ; 0–100 mm ) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score ( WOMAC ) in the osteoarthritis trial . Outlook : The results of these two studies ( available in 2004 ) will provide health care providers and policy makers with the information needed to make scientifically sound assessment s of acupuncture therapy OBJECTIVE Descriptions of the interventions used in acupuncture studies are often incomplete . The aim of this paper is to describe participating trial physicians and interventions in a r and omised trial of acupuncture for low back pain .  DESIGN Three-armed , r and omized , controlled multicenter trial with 1-year follow-up . A total of 301 patients with low-back pain were r and omized to 12 sessions of  semist and ardized acupuncture ( at least six local and two distant points needled bilaterally from a selection of predefined points , but individual choice of additional body or ear acupuncture points possible ) , minimal acupuncture ( superficial needling of at least 6 of 10 predefined , bilateral , distant nonacupuncture points ) , or a waiting list control ( 2 months no acupuncture followed by semist and ardised acupuncture described above ) . OUTCOME MEASURES Participating trial physicians and interventions  . RESULTS Forty-five ( 45 ) physicians specializing in acupuncture ( mean age 44 + /- 7.8 years , 23 ( 51 % ) female ) in 30 outpatient centers in Germany provided the interventions . The median duration of acupuncture training of trial physicians was 350 hours ( range 140 - 2508 ) . The most frequently reported Chinese diagnosis was  Kidney deficiency ( 39 % ) , followed by  qi and Blood stagnation  ( 24 % ) , and bi  syndrome ( 20 % ) . The total number of needles used was 17.3 + /- 4.2 in the acupuncture group compared to 12.3 + /- 1.2 in the minimal acupuncture group . In total , 40 physicians ( 89 % ) stated that they would have treated patients similarly or in exactly the same way outside of the trial , whereas 5 ( 11 % ) stated that they would have treated patients differently . CONCLUSIONS For most trial physicians , the semist and ardized acupuncture strategy used in this trial was an acceptable compromise for an efficacy study . However , a relevant minority of participating trial physicians stated that they would have treated patients differently outside of the trial Sixty patients aged 60 or over with back pain for at least 6 months were recruited from General Practitioner referrals and r and omized to 4 weeks of treatment with acupuncture or transcutaneous electrical nerve stimulation ( TENS ) .  All treatments were administered by the same physiotherapist and both groups had the same contact with him . The following were measured at baseline , completion and at a 3-month follow-up by an independent observer blinded to treatment received : ( 1 ) pain severity on visual analogue scale ( VAS ) ; ( 2 ) pain subscale of Nottingham Health Profile ( NHP ) ; ( 3 ) number of analgesic tablets consumed in previous week ; ( 4 ) spinal flexion from C7 to S1 . Thirty-two patients were r and omized to acupuncture and 28 to TENS ; only three withdrew ( two from acupuncture , one from TENS ) . Significant improvements were shown on VAS ( P < 0.001 ) , NHP ( P < 0.001 ) and tablet count ( P < 0.05 ) between baseline and completion in both groups , these improvements remaining significant comparing baseline with follow-up with a further non-significant improvement in VAS and NHP in the acupuncture group . The acupuncture but not the TENS patients showed a small but statistically significant improvement ( P < 0.05 ) in mean spinal flexion between baseline and completion which was not maintained at follow-up . Thus in these elderly patients with chronic back pain both acupuncture and TENS had demonstrable benefits which outlasted the treatment period . Acupuncture may improve spinal flexion . This trial can not exclude the possibility that both treatments are ' placebos ' Study Design . R and omized clinical trial . Objective . Compare outcomes of patients with low back pain receiving treatments matched or unmatched to their subgrouping based on initial clinical presentation . Summary of Background Data . Patients with “ nonspecific ” low back pain are often viewed as a homogeneous group , equally likely to respond to any particular intervention . Others have proposed methods for subgrouping patients as a means for determining the treatment most likely to benefit patients with particular characteristics . Methods . Patients with low back pain of less than 90 days ’ duration referred to physical therapy  were examined before treatment and classified into one of three subgroups based on the type of treatment believed most likely to benefit the patient ( manipulation , stabilization exercise , or specific exercise ) . Patients were r and omly assigned to receive manipulation , stabilization exercises , or specific exercise treatment during a 4-week treatment period . Disability was assessed in the short-term ( 4 weeks ) and long-term ( 1 year ) using the Oswestry . Comparisons were made between patients receiving treatment matched to their subgroup , versus those receiving unmatched treatment . Results . A total of 123 patients participated ( mean age , 37.7 ± 10.7 years ; 45 % female ) . Patients receiving matched treatments experienced greater short- and long-term reductions in disability than those receiving unmatched treatments . After 4 weeks , the difference favoring the matched treatment group was 6.6 Oswestry points ( 95 % CI , 0.70–12.5 ) , and at long-term follow-up the difference was 8.3 points ( 95 % CI , 2.5–14.1 ) . Compliers-only analysis of long-term outcomes yielded a similar result . Conclusions . Nonspecific low back pain should not be viewed as a homogenous condition . Outcomes can be improved when subgrouping is used to guide treatment decision-making Introduction There is some evidence for the efficacy of acupuncture , but it remains unclear whether trigger point acupuncture is effective . Our objective was to evaluate the effects of trigger point acupuncture on pain and quality of life in chronic low back pain patients compared with sham acupuncture . Methods Twenty-six consecutive out- patients ( 17 women , 9 men ; age range : 65–91 years ) from the Department of Orthopaedic Surgery , Meiji University of Oriental Medicine , with non-radiating low back pain for at least six months and normal neurological examination , were r and omised to two groups . Each group received one phase of trigger point acupuncture and one of sham acupuncture with a three week washout period between them , over 12 weeks . Group A ( n=13 ) received trigger point acupuncture in the first phase and sham acupuncture in the second . Group B ( n=13 ) received the same interventions in the reverse order . Outcome measures were pain intensity ( visual analogue scale , VAS ) and Rol and Morris Question naire . Results Nineteen patients were included in the analysis . At the end of the first treatment phase , group A receiving trigger point acupuncture scored significantly lower VAS ( P<0.001 ) and Rol and Morris Question naire scores ( P<0.01 ) than the sham control group . There were significant within-group reductions in pain in both groups during the trigger point acupuncture phase but not in the sham treatment phase . However , the beneficial effects were not sustained . Conclusion These results suggest that trigger point acupuncture may have greater short term effects on low back pain in elderly patients than sham acupuncture Objective There is some evidence for the efficacy of acupuncture in chronic low back pain , but it remains unclear which acupuncture modes are most effective . Our objective was to evaluate the effects of two different modes of trigger point acupuncture on pain and quality of life in chronic low back pain patients compared to st and ard acupuncture treatment . Methods Thirty five consecutive out- patients ( 25 women , 10 men ; age range : 65–81 years ) from the Department of Orthopaedic Surgery , Meiji University of Oriental Medicine , with non-radiating low back pain for at least six months and normal neurological examination , were r and omised to one of three groups over 12 weeks . Each group received two phases of acupuncture treatment with an interval between them . Nine patients dropped out during the course of the study . The st and ard acupuncture group ( n=9 ) received treatment at traditional acupuncture points for low back pain , while the other acupuncture groups received superficial ( n=9 ) or deep ( n=9 ) treatments on trigger points . Outcome measures were VAS pain intensity and Rol and Morris Question naire . Results After treatment , the group that received deep needling to trigger points reported less pain intensity and improved quality of life compared to the st and ard acupuncture group or the group that received superficial needling to trigger points , but the differences were not statistically significant . There was a significant reduction in pain intensity between the treatment and interval in the group that received deep needling to trigger points ( P<0.01 ) , but not in the st and ard acupuncture group or the group that received superficial needling to trigger points . Conclusion These results suggest that deep needling to trigger points may be more effective in the treatment of low back pain in elderly patients than either st and ard acupuncture therapy , or superficial needling to trigger points OBJECTIVE Flexion distraction is a commonly used form of chiropractic care with chiropractor utilization rates of 58 % . However , no previous r and omized clinical trial has assessed the effectiveness of this form of care . The objective of this investigation was to compare the pain and disability during the year after active care based on treatment group allocation ( Flexion Distraction versus Exercise Program ) . STUDY DESIGN R and omized clinical trial , follow-up . SUBJECTS Two hundred and thirty-five ( 235 ) subjects who were previously r and omized to either chiropractic care ( flexion distraction ) or physical therapy ( exercise program ) within a clinical trial . OUTCOME MEASURES Subjects were followed for 1 year via mailed question naires to assess levels of pain ( Visual Analog Scale ) and dysfunction ( Rol and Morris ) . RESULTS Study subjects had a decrease in pain and disability after intervention regardless of which group they attended ( p < 0.002 ) , however , during the year after care , subjects who received chiropractic care ( flexion distraction therapy ) had significantly lower pain scores than subjects who received physical therapy ( exercise program ) ( p = 0.02 ) . CONCLUSIONS In this first trial on flexion distraction care , flexion distraction was found to be more effective in reducing pain for 1 year when compared to a form of physical therapy OBJECTIVE To compare needle acupuncture , medication ( tenoxicam with ranitidine ) , and spinal manipulation for managing chronic ( > 13 weeks duration ) spinal pain syndromes . DESIGN Prospect i ve , r and omized , independently assessed preintervention and postintervention clinical pilot trial . SETTING Specialized spinal pain syndrome out-patient unit at Townsville General Hospital , Queensl and , Australia . SUBJECTS Seventy-seven patients ( without contraindication to manipulation or medication ) were recruited . INTERVENTIONS One of three separate , clearly defined intervention protocol s : needle acupuncture , nonsteroidal anti-inflammatory medication , or chiropractic spinal manipulation . MAIN OUTCOME MEASURES Main outcome measures were changes ( 4 weeks vs. initial visit ) in the scores of the ( 1 ) Oswestry Back Pain Disability Index , ( 2 ) Neck Disability Index , and ( 3 ) three visual analogue scales of local pain intensity . RESULTS R and omization was successful . After a median intervention period of 30 days , spinal manipulation was the only intervention that achieved statistically significant improvements ( all expressed as percentages of the original scores ) with ( 1 ) a reduction of 30.7 % on the Oswestry scale , ( 2 ) an improvement of 25 % on the neck disability index , and ( 3 ) reductions on the visual analogue scale of 50 % for low back pain , 46 % for upper back pain , and 33 % for neck pain ( all P<.001 ) . Neither of the other interventions showed any significant improvement on any of the outcome measures . CONCLUSIONS The consistency of the results provides , in spite of several discussed shortcomings of this pilot study , evidence that in patients with chronic spinal pain syndromes  spinal manipulation , if not contraindicated , results in greater improvement than acupuncture and medicine Fifty-six male patients who had chronic low-back pain of at least 12 weeks ' duration ( average duration , 28.6 weeks ) and who had failed to respond to traditional medical or surgical therapy were entered into a r and omized clinical trial to compare the relative efficacies of the Clinic 's st and ard therapy regimen with and without dry needling at muscle motor points . Before entering the trial , all patients had undergone without improvement eight weeks of the Clinic 's st and ard therapy regimen of physiotherapy , remedial exercises , and occupational therapy . The 29 study subjects and 27 control patients then continued with this regimen , but the study subjects also received needling at muscle motor points once or twice a week ( average number of treatments , 7.9 ) . All patients were assessed at the time of discharge , 12 weeks after discharge , and at the time of writing ( average , 27.3 weeks ) . The group that had been treated with needling was found to be clearly and significantly better than the control group ( P > 0.005 , N = 53 ) with regard to status at discharge , status at 12 weeks ' follow-up , and status at final follow-up . At final followup , 18 of the 29 study subjects had returned to their original or equivalent jobs and 10 had returned to lighter employment . In the control group , only four had returned to their original work and 14 to lighter employment ; nine were still disabled . The results seem to justify the procedure in chronic low-back patients in whom myofascial pain ( the majority ) rather than skeletal irritation is the dominant disabling feature Study Design . A r and omized controlled trial was conducted . Objective . To determine the efficacy of osteopathic manipulative treatment as a complementary treatment for chronic nonspecific low back pain . Summary of Background Data . Osteopathic manipulative treatment may be useful for acute or subacute low back pain . However , its role in chronic low back pain is unclear . Methods . This trial was conducted in a university-based clinic from 2000 through 2001 . Of the 199 subjects who responded to recruitment procedures , 91 met the eligibility criteria . They were r and omized , with 82 patients completing the 1-month follow-up evaluation , 71 completing the 3-month evaluation , and 66 completing the 6-month evaluation . The subjects were r and omized to osteopathic manipulative treatment , sham manipulation , or a no-intervention control group , and they were allowed to continue their usual care for low back pain . The main outcomes included the SF-36 Health Survey , a 10-cm visual analog scale for overall back pain , the Rol and –Morris Disability Question naire , lost work or school days because of back pain , and satisfaction with back care . Results . As compared with the no-intervention control subjects , the patients who received osteopathic manipulative treatment reported greater improvements in back pain , greater satisfaction with back care throughout the trial , better physical functioning and mental health at 1 month , and fewer cotreatments at 6 months . The subjects who received sham manipulation also reported greater improvements in back pain and physical functioning and greater satisfaction than the no-intervention control subjects . There were no significant benefits with osteopathic manipulative treatment , as compared with sham manipulation . Conclusions . Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain . It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment , such as range of motion activities or time spent interacting with patients , which may represent placebo effects OBJECTIVE This r and omized , double-dummy , double-blind pilot study of acutely exacerbated low back pain was aim ed to inform a definitive comparison between Doloteffin , a proprietary extract of Harpagophytum , and rofecoxib , a selective inhibitor of cyclo-oxygenase-2 ( COX-2 ) . METHODS Forty-four patients ( phyto-anti-inflammatory drug-PAID-group ) received a daily dose of Doloteffin containing , inter alia , 60 mg of harpagoside for 6 weeks and 44 ( non-steroidal anti-inflammatory drug-NSAID-group )  received 12.5 mg/day of rofecoxib . All were allowed rescue medication of up to 400 mg/day of tramadol . Several outcome measures were examined at various intervals to obtain estimates of effect size and variability that might be used to decide the most suitable principal outcome measure and corresponding numbers required for a definitive study . RESULTS Forty-three PAID and 36 NSAID patients completed the study . Ten PAID and 5 NSAID patients reported no pain without rescue medication for at least 5 days of the 6th week of treatment . Eighteen PAID and 12 NSAID patients had more than a 50 % reduction in the week 's average of their pain scores between the 1st and 6th weeks . The mean percentage decrease from baseline in the pain component of the Arhus Index was 23 ( S.D. 52 ) in PAID and 26 ( S.D. 43 ) in NSAID . The corresponding measures for the overall Arhus Index were 11 ( 31 ) and 16 ( 24 ) and , for the Health Assessment Question naire , 7 ( 8) and 6 ( 7 ) . Tramadol was used by 21 PAID patients and 13 NSAID patients . Fourteen patients in each group experienced 39 adverse effects , of which 28 ( 13 in PAID ) were judged to some degree attributable to the study medications . CONCLUSION Though no significant intergroup differences were demonstrable , large numbers will be needed to show equivalence 81 patients with chronic low back pain ( average duration 10 years ) were r and omised to two treatment groups . 40 received an empirically devised regimen of forceful spinal manipulation and injections of a dextrose-glycerine-phenol ( " proliferant " ) solution into soft-tissue structures , as part of a programme to decrease pain and disability . The other 41 patients received parallel treatment in which the main differences were less extensive initial local anaesthesia and manipulation , and substitution of saline for proliferant . Neither patients nor assessors knew which treatment had been given . When assessed by disability scores the experimental group had greater improvement than the control group at one ( p less than 0.001 ) , three ( p less than 0.004 ) , and six ( p less than 0.001 ) months from the end of treatment ; at six months an improvement of more than 50 % was recorded in 35 of the experimental group versus 16 of the control group and the numbers free from disability were 15 and 4 , respectively ( p less than 0.003 ) . Visual analogue pain scores and pain diagrams likewise showed significant advantages for the experimental regimen Low Back Pain Rating scale is an index scale which includes measurements of pain intensity , disability , and physical impairment . The scale was design ed to monitor the outcome of clinical trials of low back pain treatment . It has been vali date d in 58 patients following first-time discectomy .  The scale rating can be rapidly carried out and requires no special aids . With slight modification it can be used in office and telephone interviews , as well as postal question naires . These modifications only slightly reduce the quantity of information gathered . In the study , a high rater agreement ( 97.7 % ) was found without level difference between two observers using the scale . The validation process included : construct validity , criterion-related validity and item bias , relative to Global Assessment s pronounced by the patient and an experienced clinician . Low Back Pain Rating scale hs been shown to be valid and reliable in the assessment of low back pain 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 & NA ; Fifty‐four patients treated in a 3‐week inpatient rehabilitation program were r and omly assigned to and accepted treatment with electroacupuncture ( n = 17 ) , TENS ( low intensity transcutaneous nerve stimulation , n = 18 ) , and TENS dead‐battery ( placebo , n = 18 ) . Outcome measures included estimates of pain ( on a Visual Analogue Scale ) and disability by both physician and patient , physical measures of trunk strength and spine range of motion , as well as the patient 's perceptions of the relative contribution of the education , exercise training , and the electrical stimulation . Analyses of variance were utilized to determine effects of treatment ( electroacupuncture , TENS , placebo ) across time ( admission , discharge , and return ) for the outcome measures . There were no significant differences between treatment groups with respect to their overall rehabilitation . All 3 treatment groups ranked the contribution of the education as being greater than the electrical stimulation . However , the electroacupuncture group consistently demonstrated greater improvement on the outcome measures than the other treatment groups . For the visual analogue scale measure of average pain , there was a statistical trend at the return visit suggesting that the acupuncture group was experiencing less pain Two daily doses of oral Harpagophytum extract WS 1531 ( 600 and 1200 , respectively , containing 50 and 100 mg of the marker harpagoside ) were compared with placebo over 4 weeks in a r and omized , double-blind study in 197 patients with chronic susceptibility to back pain and current exacerbations that were producing pain worse than 5 on a 0 - 10 visual analogue scale . The principal outcome measure , based on pilot studies , was the number of patients who were pain free without the permitted rescue medication  ( tramadol ) for 5 days out of the last week . The treatment and placebo groups were well matched in physical characteristics , in the severity of pain , duration , nature and accompaniments of their pain , the Arhus low back pain index and in laboratory indices of organ system function . A total of 183 patients completed the study . The numbers of pain-free patients were three , six and 10 in the placebo group ( P ) , the Harpagophytum 600 group ( H600 ) and the Harpagophytum 1200 group ( H1200 ) respectively ( P = 0.027 , one-tailed Cochrane-Armitage test ) . The majority of responders ' were patients who had suffered less than 42 days of pain  , and subgroup analyses suggested that the effect was confined to patients with more severe and radiating pain accompanied by neurological deficit . However , subsidiary analyses , concentrating on the current pain component of the Arhus index , painted a slightly different picture , with the benefits seeming , if anything , to be greatest in the H600 group and in patients without more severe pain , radiation or neurological deficit .  Patients with more pain tended to use more tramadol , but even severe and unbearable pain would not guarantee that tramadol would be used at all , and certainly not to the maximum permitted dose . There was no evidence for Harpagophytum-related  side-effects , except possibly for mild and infrequent gastrointestinal symptoms Objective The authors sought to determine whether a series of needle acupuncture treatments produced long-term relief of  chronic low back pain .  Design A blinded placebo-controlled study with an independent observer . The patients were r and omized to receive manual acupuncture , electroacupuncture , or active placebo ( mock transcutaneous electrical nerve stimulation ) . Subjects were examined and monitored by an investigator who was blinded to the treatment given . Setting A tertiary-level pain clinic at a Swedish university hospital . Patients Fifty consecutive patients ( 33 women , 17 men ; mean age , 49.8 years ) with chronic low back pain ( mean pain duration , 9.5 years ) and without rhizopathy or history of acupuncture treatment were included in the study . Interventions Treatments were given once per week for 8 weeks . Two further treatments were given during the follow-up assessment period of 6 months or longer . Outcome Measures The independent observer made a global assessment of the patients 1 , 3 , and 6 months after treatment . The patients kept pain diaries to score pain intensity twice daily , analgesic intake , and quality of sleep daily , and activity level weekly . Results At the 1-month independent assessment , 16 of 34 patients in the acupuncture groups and 2 of 16 patients in the placebo group showed improvement ( p < 0.05 ) . At the 6-month follow-up assessment , 14 of 34 patients in the acupuncture groups and 2 of 16 patients in the placebo group showed improvement ( p < 0.05 ) . A significant decrease in pain intensities occurred at 1 and 3 months in the acupuncture groups compared with the placebo group . There was a significant improvement in return to work , quality of sleep , and analgesic intake in subjects treated with acupuncture . Conclusions The authors found a long-term pain-relieving effect of needle acupuncture compared with true placebo in some patients with chronic nociceptive low back pain The professional literature contains relatively few r and omized-control studies that have assessed the efficacy of physical therapy approaches to the management of patients with chronic low back pain ( CLBP ) .  The purpose s of this study were : 1 ) to investigate the effects of physical agents , joint manipulation , low-tech exercise , and high-tech exercise on objective measures of CLBP ; 2 ) to track the length of CLBP relief ; and 3 ) to determine treatment cost-effectiveness .  Two-hundred-fifty subjects ( 68 females , 182 males ; ages 34 - 51 years ) with CLBP following an L5 laminectomy  were r and omly assigned into five separate groups for a treatment period of 8 weeks . Chronic low back pain status was measured by modified-modified Schober , Cybex Liftask , and Oswestry procedures . Results revealed that : 1 ) only low-tech and high-tech exercise produced significant improvements ( p < .05 ) in CLBP , 2 ) the mean period of CLBP relief ranged from 1.6 weeks ( control ) to 91.4 weeks ( low-tech exercise ) , and 3 ) low-tech exercise was most cost-effective . It was concluded that : 1 ) low-tech and high-tech exercise were the only effective treatments for CLBP , 2 ) low-tech exercise produced the longest period of CLBP relief , and 3 ) low-tech exercise was the most cost-effective form of treatment . Clinical ly , low-tech exercise may be the treatment method of choice for the effective management of chronic low back pain Acupuncture treatment of chronic low back pain was studied in a placebo-controlled double-blind crossover trial completed by 77 patients . The patients had significantly increased depression , neuroticism , and hypochondriasis scores . Initial pain levels correlated with state-anxiety , depression , pain duration , and abnormal illness behavior measures , as well as with the intake of psychotropic but not analgesic medication . Overall reduction in pain score was 26 percent for acupuncture and 22 percent for placebo treatment ; the difference was not significant ( p greater than 0.6 ) .  Analgesic drug intake was reduced to a similar extent in both groups . During the first phase of treatment , patients receiving acupuncture had a greater but not significantly different reduction in pain rating scores compared with those receiving placebo ( t = 0.52 ; p greater than 0.6 ) . This group showed significantly lower pain scores ( p less than 0.05 ) in the second phase of the trial while receiving placebo treatment . Overall reduction in individual patient 's pain score was best predicted by initial pain severity ( r = 0.43 ; p less than 0.001 ) and psychotropic drug intake ( r = 0.37 ; p less than 0.001 ) . None of the variables tested predicted which patients would specifically respond to acupuncture or placebo BACKGROUND The efficacy of acupuncture treatment for chronic low-back pain has not been reliably proven because of a lack of good quality studies , leading to the necessity of developing the German Acupuncture Trial for Chronic Low-Back Pain ( GERAC-cLBP ) study . OBJECTIVE The aim is to assess the effectiveness of traditional Chinese acupuncture for chronic low-back pain compared to sham acupuncture and with a conventional st and ard therapy . METHODS This trial is a nationwide , multicenter , r and omized , prospect i ve , partially blinded study . The primary endpoint is the success rate after 6 months . Success is defined as an improvement of 33 % or more of three pain-related items on the Van-Korff Pain Score or an improvement of 12 % or more in the disability measured by the Hanover Functional Ability Question naire . Assessment of the effectiveness of the blinding of patients to the form of acupuncture they received will be conducted . All clinical endpoints are assessed central ly by blinded independent observers . The sample size , with a total of 1062 patients to be enrolled , is based on power calculations . Independent central r and omization , data collection , data processing , and statistical analysis are provided . Success rates will be tested for differences using two-sided Fisher exact tests . In the primary analysis , all tests will be carried out on the basis of the intention-to-treat principle . Secondary analyses will be conducted according to protocol approaches . TRIAL STATUS The pilot phase of the trial started in February 2002 , the estimated duration of the study is 2.5 years . Enrollment is anticipated to be completed in the winter of 2003 . CONCLUSION The GERAC-cLBP study is currently the world 's largest controlled trial of the effectiveness of acupuncture treatment  for low-back pain . It will contribute to the evaluation of efficacy by means of evidence based medicine Study Design . A prospect i ve , r and omized controlled trial . Objective . To examine long-term effects and costs of combined manipulative treatment , stabilizing exercises , and physician consultation compared with physician consultation alone for chronic low back pain ( cLBP ) . Summary of Background Data . An obvious gap exists in knowledge concerning long-term efficacy and cost-effectiveness of manipulative treatment methods . Methods . Of 204 patients with cLBP whose Oswestry Disability Index ( ODI ) was at least 16 % , 102 were r and omized into a combined manipulative treatment , exercise , and physician consultation group ( i.e. , a combination group ) , and 102 to a consultation alone group . All patients were clinical ly examined , informed about their back pain , and encouraged to stay active and exercise according to specific instructions based on clinical evaluation . Treatment included 4 sessions of manual therapy and stabilizing exercises aim ed at correcting the lumbopelvic rhythm . Question naires inquired about pain ( visual analog scale [ VAS ] ) , disability ( ODI ) , health-related quality of life ( 15D Quality of Life Instrument ) , satisfaction with care , and costs . Results . Significant improvement occurred in both groups on every self-rated outcome measurement . Within 2 years , the combination group showed only a slightly more significant reduction in VAS ( P = 0.01 , analysis of variance ) but clearly higher patient satisfaction ( P = 0.001 , Pearson & khgr;2 ) as compared to the consultation group . Incremental analysis showed that for combined group compared to consultation group , a one-point change in VAS scale cost $ 512 . Conclusions . Physician consultation alone was more cost-effective for both health care use and work absenteeism , and led to equal improvement in disability and health-related quality of life . It seems obvious that encouraging information and advice are major elements for the treatment of patients with cLBP Preliminary findings are presented of a double-blind , crossover trial comparing the effects of traditional with placebo acupuncture in relieving  chronic low back pain . 77 patients completed the study . Following initial assessment and baseline readings , patients had a 4-week course of active or placebo treatment given twice weekly . After a 4 week rest period patients received the alternate treatment , using the same time schedule . A 4 week follow-up period completed the trial . Using visual analogue scale readings as a measure of pain there was no cumulative difference in pain reduction achieved by traditional as compared with placebo acupuncture treatment . Both groups achieved a 55 % overall reduction in pain level at the end of the trial , compared with initial baseline readings
The purpose of this systematic review was to assess the effects of spinal manipulative therapy ( SMT ) , acupuncture and herbal medicine for chronic non-specific LBP .