IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT): Cluster randomised controlled trial study protocol Intensive group training versus cognitive intervention in sub-acute low back pain: short-term results of a single-blind randomized controlled trial. Integrating Mobile health and Physical Activity to reduce the burden of Chronic low back pain Trial (IMPACT): a pilot trial protocol A fitness programme for patients with chronic low back pain: 2-year follow-up of a randomised controlled trial Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial Evaluation of a specific home exercise program for low back pain. Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): A cluster randomised trial protocol Motor Control Exercise for Chronic Low Back Pain: A Randomized Placebo-Controlled Trial Implementation of a multidisciplinary program for active duty personnel seeking care for low back pain in a U.S. Navy Medical Center: a feasibility study. Spinal segmental stabilisation exercises for chronic low back pain: programme adherence and its influence on clinical outcome Efficacy of graded activity versus supervised exercises in patients with chronic non-specific low back pain: protocol of a randomised controlled trial Preventing chronic back pain: evaluation of a theory-based cognitive-behavioural training programme for patients with subacute back pain. Randomised controlled trial for evaluation of fitness programme for patients with chronic low back pain. Active Exercise, Education, and Cognitive Behavioral Therapy for Persistent Disabling Low Back Pain: A Randomized Controlled Trial Enhanced implementation of low back pain guidelines in general practice: study protocol of a cluster randomised controlled trial A randomized trial of behavioral physical therapy interventions for acute and sub-acute low back pain (NCT00373867)
Background Evidence generated from reliable research is not frequently implemented into clinical practice . Evidence -based clinical practice guidelines are a potential vehicle to achieve this . A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines . Recommendations from this review , and other studies , have suggested the use of interventions that are theoretically based because these may be more effective than those that are not . An evidence -based clinical practice guideline for the management of acute low back pain was recently developed in Australia . This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common , has a high burden , and for which there is an evidence - practice gap in the primary care setting . Aim This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria , Australia . Specifically , our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray  , and improving mean level of disability for patients three months post-consultation . Methods / Design This study protocol describes the details of a cluster r and omised controlled trial . Ninety-two general practice s ( clusters ) , which include at least one consenting general practitioner , will be r and omised to an intervention or control arm using restricted r and omisation . Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion . An average of twenty-five patients per general practice will be recruited , providing a total of 2,300 patient participants . General practitioners in the control arm will receive access to the guideline using the existing dissemination strategy . Practitioners in the intervention arm will be invited to participate in facilitated face-to-face workshops that have been underpinned by behavioural theory . Investigators ( not involved in the delivery of the intervention ) , patients , outcome assessors and the study statistician will be blinded to group allocation . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN012606000098538 ( date registered 14/03/2006 ) OBJECTIVE To evaluate the short-term effect of physical exercise and a cognitive intervention in low back pain . DESIGN R and omized controlled trial . SUBJECTS Ninety-three patients sick-listed for 8 - 12 weeks for sub-acute low back pain were r and omized to an exercise regime ( n = 30 ) , a cognitive intervention ( n = 34 ) or a control group ( n = 29 ) . METHODS Primary outcome measures were pain , disability , sick-listing and satisfaction with care . Secondary outcome measures were self-efficacy for pain and for function , fear-avoidance beliefs , emotional distress , generic health status and life satisfaction . RESULTS Eighteen percent of subjects dropped out . Drop-out was most frequent in the exercise group . At 18 weeks after inclusion fear-avoidance beliefs were reduced in both intervention groups . The cognitive group demonstrated significant improvement in disability , self-efficacy for pain , emotional distress , general health and life satisfaction . Patients in the exercise group were significantly more satisfied with the treatment , and patients following the exercise protocol reduced pain significantly . No effect on sick-listing was seen . CONCLUSION Cognitive intervention improved disability and may be feasible for most patients sick-listed in the sub-acute phase .  Physical exercise reduced patients ' symptoms , but requires high motivation by patients . Despite positive effects in intervention groups on variables considered as negative prognostic factors for long-term disability and sickness absence , interventions had no effect on sick-listing Background It is well recognised that low back pain is a significant public health problem and engagement in moderate levels of physical activity is associated with positive outcomes .Conservative active care , such as exercise , is effective in reducing pain and disability associated with chronic low back pain . However , a rapid decline in clinical outcomes is commonly seen after discharge from treatment . Methods / Design We will conduct a r and omised controlled trial to investigate the effectiveness of a mobile health supported physical activity intervention ( compared to st and ard care ) in care-seeking , pain and disability in people with chronic low back pain after discharge from treatment . We will recruit 68 patients with chronic low back pain following discharge from an outpatient hospital program , who will be r and omly allocated to the physical activity intervention ( n = 34 ) or the st and ard care group ( n = 34 ) and monitored for 6 months . The physical activity intervention will involve a physical activity advice booklet , a face-to-face health coaching session and 12 fortnightly follow-up telephone-based health coaching sessions . This intervention will be supported by provision of a specifically design ed web app and a physical activity monitoring device ( FitBit ) . The st and ard care group will receive the physical activity advice booklet only . Discussion This pilot trial will investigate a new model to prevent clinical decline in people following conservative treatment for chronic low back pain . If proven to be effective , this approach will constitute a major advance in the management of low back pain . Chronic patients who experience recurrent pain and disability after treatment are prone to seek additional care in the form of physiotherapy , medication , emergency department attendance , specialist consultation or spinal surgery . This model aims to maintain functional levels and reduce care-seeking empowering patients to self-manage their low back pain by offering them a contemporary patient-centred physical activity program with the support of mobile health technology . The outcomes of this trial will have immediate implication s for clinical practice .Trial registration ACTRN12615000189527 ( 26 - 02 - 2015 ) & NA ; The aim of this study was to assess the long‐term effect of a supervised fitness programme on patients with chronic low back pain . The design of the study was a single blind r and omised controlled trial with follow‐up , by postal question naire , 2 years after intervention . The Oswestry Low Back Pain Disability Index was used as the outcome measure to assess daily activity affected by back pain . Eighty‐one patients with chronic low back pain , who were referred to the physiotherapy department of a National Health Service orthopaedic hospital , were r and omised to either a supervised fitness programme or a control group . Patients in the intervention group and control group were taught specific exercises to be continued at home and referred to a backschool for back care education . In addition , the intervention group attended eight sessions of a supervised fitness programme .  Sixty‐two patients ( 76 % ) with a mean age of 37 years , returned the Oswestry Low Back Pain Disability Index question naire . Of these , 29 were in the intervention group and 31 in the control group . Patients in the intervention group demonstrated a mean reduction of 7.7 % in the Oswestry Low Back Pain Disability Index score ( 95 % confidence interval of mean paired difference 3.9 , 11.6 P<0.001 ) , compared with only 2.4 % in the control group ( 95 % confidence interval of mean paired difference −2.0 , 6.9 P>0.05 ) . Between group comparisons demonstrated a statistically significant difference in disability scores between the treatment and control group ( mean difference 5.8 , 95 % confidence interval 0.3 , 11.4 P<0.04 ) . This study supports the current trend towards a more active treatment approach to low back pain . We have demonstrated clinical effectiveness of a fitness programme 2 years after treatment but this needs to be replicated in a larger study which should include a cost effectiveness analysis , further analysis of objective functional status and a placebo intervention group Abstract Objective : To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities . Design : R and omised controlled trial of progressive exercise programme compared with usual primary care management . Patients ' preferences for type of management were elicited independently of r and omisation . Participants : 187 patients aged 18 - 60 years with mechanical low back pain of 4 weeks to 6 months ' duration . Interventions : Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups , stretching exercises , relaxation session , and brief education on back care . A cognitive-behavioural approach was used . Main outcome measures : Assessment s of debilitating effects of back pain before and after intervention and at 6 months and 1 year later . Measures included Rol and disability question naire , Aberdeen back pain scale , pain diaries , and use of healthcare services . Results : At 6 weeks after r and omisation , the intervention group improved marginally more than the control group on the disability question naire and reported less distressing pain . At 6 months and 1 year , the intervention group showed significantly greater improvement in the disability question naire score ( mean difference in changes 1.35 , 95 % confidence interval 0.13 to 2.57 ) . At 1 year , the intervention group also showed significantly greater improvement in the Aberdeen back pain scale ( 4.44 , 1.01 to 7.87 ) and reported only 378 days off work compared with 607 in the control group . The intervention group used fewer healthcare re sources . Outcome was not influenced by patients ' preferences . Conclusions : The exercise class was more clinical ly effective than traditional general practitioner management , regardless of patient preference , and was cost effective . Key messages Patients with back pain need to return to normal activities as soon as possible but are often afraid that movement or activity may be harmful An exercise programme led by a physiotherapist in the community and based on cognitive-behavioural principles helped patients to cope better with their pain and function better even one year later Patients ' preferences for type of management did not affect outcome Patients in the intervention group tended to use fewer healthcare re sources and took fewer days off work This type of exercise programme should be more widely Background Non-specific low back pain is a common cause for consultation with the general practitioner , generating increased health and social costs . This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability , severity of pain , anxiety and depression , to improve quality of life and to reduce the incidence of chronic  low back pain in the working population with non-specific low back pain , compared to usual clinical care . Methods / Design A Cluster r and omised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona , Spain and its surrounding areas . The centres are r and omly allocated to the multidisciplinary intervention or to usual clinical care .  Patients between 18 and 65 years old ( n = 932 ; 466 per arm ) and with a diagnostic of a non-specific sub-acute low back pain are included .  Patients in the intervention group are receiving the recommendations of clinical practice guidelines , in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours . The main outcome is change in the score in the Rol and Morris disability question naire at three months after onset of pain . Other outcomes are severity of pain , quality of life , duration of current non-specific low back pain episode , work sick leave and duration , Fear Avoidance Beliefs and Goldberg Question naires . Outcomes will be assessed at baseline , 3 , 6 and 12 months . Analysis will be by intention to treat . The intervention effect will be assessed through the st and ard error of measurement and the effect-size . Responsiveness of each scale will be evaluated by st and ardised response mean and receiver-operating characteristic method . Recovery according to the patient will be used as an external criterion . A multilevel regression will be performed on repeated measures . The time until the current episode of low back pain takes to subside will be analysed by Cox regression . Discussion We hope to provide evidence of the effectiveness of the proposed biopsychosocial multidisciplinary intervention in avoiding the chronification of low back pain , and to reduce the duration of non-specific low back pain episodes . If the intervention is effective , it could be applied to Primary Health Care Centres . Trial Registration IS RCT BACKGROUND The prescription of exercise as a conservative treatment for lumbar pain is frequent and seems effective for the chronic cases of nonspecific low back pain . However , there is no evidence favoring one type of exercise over another . Often , exercise programs are prescribed without adequate evaluation of the individual characteristics like posture , muscular force , and extensibility . Patients with totally different causes of low back pain will often be given the same type of exercises . OBJECTIVE Our objective was to compare the effectiveness of 2 home exercise programs in decreasing disability and pain related to subacute and chronic nonspecific low back pain . To do so we compared a specific ( individualized ) exercise program with a program of commonly prescribed exercises for low back pain . METHOD In a control group study , 20 patients with chronic or subacute nonspecific low back pain participated after giving their informed consent . All subjects were evaluated ( physical evaluation of lumbar and pelvic muscles [ 1 ] force and [ 2 ] extensibility , [ 3 ] trunk range of motion ) and then divided in 2 groups : 10 patients received specific exercises ( experimental group ) based on their evaluation , and 10 patients received a commonly prescribed exercise program for low back pain ( control group ) . Six weeks later a second physical evaluation was conducted . Pain ( visual analog pain scale ) and disability ( modified Oswestry ) question naires were also completed by each subject at both evaluations . DESIGN This was a r and omized experimental study . RESULTS Both groups had similar age , weight , and sex characteristics . The experimental group showed significant improvements for some components targeted by the program . The control group significantly had improvement of some physical characteristics not related to their initial deficits . Even if both groups showed some improvements in muscular force and extensibility , only the members of the group who received specific exercises significantly reduced their level of pain and disability . Both groups showed a similar rate of participation in the program . CONCLUSION The results of this study suggest that applying a specific physical evaluation and exercise prescription is an appropriate treatment for people having subacute or chronic nonspecific pain . Thus clinicians should prescribe exercise programs based on individual muscular deficits rather than most commonly prescribed exercise programs Background Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care . A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines . Further , the review recommended the use of theory in the development of implementation interventions . A clinical practice guideline for the management of acute low-back pain has been developed in Australia ( 2003 ) . Acute low-back pain is a common condition , has a high burden , and there is some indication of an evidence - practice gap in the allied health setting . This provides an opportunity to develop and test a theory-based implementation intervention which , if effective , may provide benefits for patients with this condition . Aims This study aims to estimate the effectiveness of a theory-based intervention  to increase allied health practitioners ' ( physiotherapists and chiropractors in Victoria , Australia ) compliance with a clinical practice guideline for acute non-specific low back pain ( LBP ) , compared with providing practitioners with a printed copy of the guideline . Specifically , our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray  , and improving mean level of disability for patients three months post-onset of acute LBP . Methods The design of the study is a cluster r and omised trial . Restricted r and omisation was used to r and omise 210 practice s ( clusters ) to an intervention or control group . Practitioners in the control group received a printed copy of the guideline . Practitioners in the intervention group received a theory-based intervention developed to address prospect ively identified barriers to practitioner compliance with the guideline . The intervention primarily consisted of an educational symposium .  Patients aged 18 years or older who visit a participating practitioner for acute non-specific LBP of less than three months duration over a two-week data collection period , three months post the intervention symposia , are eligible for inclusion . Sample size calculations are based on recruiting between 15 to 40 patients per practice . Outcome assessors will be blinded to group allocation . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN12609001022257 ( date registered 25th November 2009 Background The evidence that exercise intervention is effective for treatment of chronic low back pain comes from trials that are not placebo-controlled . Objective The purpose of this study was to investigate the efficacy of motor control exercise for people with chronic low back pain . Design This was a r and omized , placebo-controlled trial . Setting The study was conducted in an outpatient physical therapy department in Australia . Patients The participants were 154 patients with chronic low back pain of more than 12 weeks ’ duration . Intervention Twelve sessions of motor control exercise ( ie , exercises design ed to improve function of specific muscles of the low back region and the control of posture and movement ) or placebo ( ie , detuned ultrasound therapy and detuned short-wave therapy ) were conducted over 8 weeks . Measurements Primary outcomes were pain intensity , activity ( measured by the Patient-Specific Functional Scale ) , and patient 's global impression of recovery measured at 2 months . Secondary outcomes were pain ; activity ( measured by the Patient-Specific Functional Scale ) ; patient 's global impression of recovery measured at 6 and 12 months ; activity limitation ( measured by the Rol and -Morris Disability Question naire ) at 2 , 6 , and 12 months ; and risk of persistent or recurrent pain at 12 months . Results The exercise intervention  improved activity and patient 's global impression of recovery but did not clearly reduce pain at 2 months . The mean effect of exercise on activity ( measured by the Patient-Specific Functional Scale ) was 1.1 points ( 95 % confidence interval [CI]=0.3 to 1.8 ) , the mean effect on global impression of recovery was 1.5 points ( 95 % CI=0.4 to 2.5 ) , and the mean effect on pain was 0.9 points ( 95 % CI=−0.01 to 1.8 ) , all measured on 11-point scales . Secondary outcomes also favored motor control exercise . Limitation Clinicians could not be blinded to the intervention they provided . Conclusions Motor control exercise produced short-term improvements in global impression of recovery and activity , but not pain , for people with chronic low back pain . Most of the effects observed in the short term were maintained at the 6- and 12-month follow-ups The aim of the pilot study was to evaluate a multidisciplinary program for nonspecific low back pain ( NSLBP ) at a major U.S. Navy base . In this single blinded r and omized clinical trial , subjects were drawn from a larger , prospect i ve cohort of active duty service members seeking care for NSLBP pain at a U.S. Navy Branch Medical Clinic . Outcome measures included return to work , self-reported pain , function , and psychological distress . Subjects were r and omly allocated to one of two study arms : a multidisciplinary reconditioning program or the current st and ard of care for low back pain . The intervention lasted 4 weeks with a 12-week follow-up . Thirty-three subjects were enrolled . Subjects allocated to multidisciplinary care reported significantly lower perceived disability ( p = 0.014 ) and less pain than those allocated to usual care at the end of the intervention period . All subjects returned to their usual duty following the conclusion of the intervention . The implementation of the intervention program was successful . Subjects in the multidisciplinary program showed a clinical ly significant improvement in the perception of disability compared to the usual care group . This is an important finding since perception of disability is associated with long-term functional outcome Exercise rehabilitation is one of the few evidence -based treatments for chronic non-specific low back pain ( cLBP ) , but individual success is notoriously variable and may depend on the patient ’s adherence to the prescribed exercise regime . This prospect i ve study examined factors associated with adherence and the relationship between adherence and outcome after a programme of physiotherapeutic spine stabilisation exercises .  A total of 32/37 patients with cLBP completed the study ( mean age , 44.0 ( SD = 12.3 ) years ; 11/32 ( 34 % ) male ) . Adherence to the 9-week programme was documented as : percent attendance at therapy , percent adherence to daily home exercises ( patient diary ) and percent commitment to rehabilitation ( Sports Injury Rehabilitation Adherence Scale ( SIRAS ) ) . The average of these three measures formed a multidimensional adherence index ( MAI ) . Psychological disturbance , fear-avoidance beliefs , catastrophising , exercise self-efficacy and health locus of control were measured by question naire ; disability in everyday activities was scored with the Rol and –Morris disability scale and back pain intensity with a 0–10 graphic rating scale . Overall , adherence to therapy was very good ( average MAI score , 85 % ; median ( IQR ) , 89 (15)% ) . The only psychological/beliefs variable showing a unique significant association with MAI was exercise self-efficacy ( Rho = 0.36 , P = 0.045 ) . Pain intensity and self-rated disability decreased significantly after therapy ( each P < 0.01 ) .  Adherence to home exercises  showed a moderate , positive correlation with the reduction in average pain ( Rho = 0.54 , P = 0.003 ) and disability ( Rho = 0.38 , P = 0.036 ) ; higher MAI scores were associated with greater reductions in average pain ( Rho = 0.48 , P = 0.008 ) and a ( n.s . ) tendency for greater reductions in disability ( Rho = 0.32 , P = 0.07 ) Neither attendance at therapy nor SIRAS were significantly related to any of the outcomes . The benefits of rehabilitation depended to a large extent on the patient ’s exercise behaviour outside of the formal physiotherapy sessions . Hence , more effort should be invested in finding ways to improve patients ’ motivation to take responsibility for the success of their own therapy , perhaps by increasing exercise self-efficacy . Whether the “ adherence– outcome ” interaction was mediated by improvements in function related to the specific exercises , or by a more “ global ” effect of the programme , remains to be examined Background Low back pain is a relevant public health problem , being an important cause of work absenteeism worldwide , as well as affecting the quality of life of sufferers and their individual functional performances . Supervised active physical routines and of cognitive-behavioral therapies are recommended for the treatment of chronic Low back pain , although evidence to support the effectiveness of different techniques is missing . Accordingly , the aim of this study is to contrast the effectiveness of two types of exercises , grade d activity or supervised , in decreasing symptoms of chronic low back pain . Methods / design Sample will consist of 66 patients , blindly allocated into one of two groups : 1 ) Grade d activity which , based on an operant approach , will use time-contingent methods aim ing to increase participants ’ activity levels ; 2 ) Supervised exercise , where participants will be trained for strengthening , stretching , and motor control targeting different muscle groups . Interventions will last one hour , and will happen twice a week for 6 weeks . Outcomes ( pain , disability , quality of life , global perceived effect , return to work , physical activity , physical capacity , and kinesiophobia ) will be assessed at baseline , at treatment end , and three and six months after treatment end . Data collection will be conducted by an investigator blinded to treatment allocation . Discussion This project describes the r and omisation method that will be used to compare the effectiveness of two different treatments for chronic low back pain : grade d activity and supervised exercises . Since optimal approach for patients with chronic back pain have yet not been defined based on evidence , good quality studies on the subject are necessary . Trial registration OBJECTIVE For long-term treatment effects , patients with subacute back pain need to adhere to treatment recommendations beyond the prescribed exercise treatment . Adherence rates are as low as 30 % , so we developed a cognitive-behavioural training programme to enhance patients ' self-efficacy , maximise severity perceptions and reduce barrier perceptions . METHOD A 2 x 4 ( group x time ) repeated measurement design was applied . Forty-seven patients with non-specific , subacute back pain were r and omly assigned to a training group ( exercise treatment plus cognitive-behavioural training programme ) or a control group ( exercise treatment only ) . RESULTS Repeated measures ANOVA revealed significant main and interaction effects ; the training group reported enhanced self-efficacy and severity perceptions , reduced barrier perceptions , and self-reported that they exercised more often than the control group over time . However , no group differences regarding pain intensity emerged . CONCLUSION Our findings demonstrate that a short and inexpensive cognitive-behavioural training programme is an effective tool to enable back pain patients to follow treatment recommendations on a regular basis . PRACTICE IMPLICATION S The short and simple intervention can easily be conducted by personnel , other than psychologists , i.e. , physiotherapists OBJECTIVE To evaluate a progressive fitness programme for patients with chronic low back pain . DESIGN Single blind r and omised controlled trial . Assessment s were carried out before and after treatment by an observer blinded to the study and included a battery of vali date d measures . All patients were followed up by postal question naire six months after treatment . SETTING Physiotherapy department of orthopaedic hospital . SUBJECTS 81 patients with chronic low back pain referred from orthopaedic consultants for physiotherapy . The patients were r and omly allocated to a fitness programme or control group . INTERVENTION Both groups were taught specific exercises to carry out at home and referred to a back-school for education in back care . Patients allocated to the fitness class attended eight exercise classes over four weeks in addition to the home programme and backschool . RESULTS Significant differences between the groups were shown in the changes before and after treatment in scores on the Oswestry low back pain disability index ( P < 0.005 ) , pain reports ( sensory P < 0.05 and affective P < 0.005 ) , self efficacy reports ( P < 0.05 ) , and walking distance ( P < 0.005 ) . No significant differences between the groups were found by the general health question naire or question naire on pain locus of control . A benefit of about 6 percentage points on the disability index was maintained by patients in the fitness group at six months . CONCLUSION There is a role for supervised fitness programmes in the management of moderately disabled patients with chronic low back pain . Further clinical trials , however , need to be established in other centres to confirm these findings Study Design . A r and omized controlled trial . Objectives . To determine 1 ) whether , among patients with persistent disabling low back pain ( LBP ) , a group program of exercise and education using a cognitive behavioral therapy ( CBT ) approach , reduces pain and disability over a subsequent 12-month period ; 2 ) the cost-effectiveness of the intervention ; and 3 ) whether a priori preference for type of treatment influences outcome . Summary of Background Data . There is evidence that both exercise and CBT delivered in specialist setting s is effective in improving LBP . There is a lack of evidence on whether such interventions , delivered by trained individuals in primary care , result in improved outcomes . Methods . The study was conducted in nine family medical practice s in East Cheshire , UK . Patients 18 to 65 years of age , consulting with LBP , were recruited ; those still reporting LBP 3 months after the initial consultation were r and omized between the two trial arms . The intervention arm received a program of eight 2-hour group exercise session over 6 weeks comprising active exercise and education delivered by physiotherapists using a CBT approach . Both arms received an educational booklet and audio-cassette . The primary outcome measures were pain ( 0–100 Visual Analogue Scale ) and disability ( Rol and and Morris Disability Scale ; score 0–24 ) . Results . A total of 196 subjects ( 84 % ) completed follow-up 12 months after the completion of the intervention program . The intervention showed only a small and nonsignificant effect at reducing pain ( −3.6 mm ; 95 % confidence interval , −8.5 , 1.2 mm ) and disability ( −0.6 score ; 95 % confidence interval , −1.6 , 0.4 ) . The cost of the intervention was low with an incremental cost-effectiveness ratio of £ 5000 ( U.S. $ 8650 ) per quality adjusted life year . In addition , patients allocated to the intervention that had expressed a preference for it had clinical ly important reductions in pain and disability . Conclusions . This intervention program produces only modest effects in reducing LBP and disability over a 1-year period . The observation that patient preference for treatment influences outcome warrants further investigation Background Evidence -based clinical practice guidelines may improve treatment quality , but the uptake of guideline recommendations is often incomplete and slow . Recently new low back pain guidelines are being launched in Denmark . The guidelines are considered to reduce personal and public costs . The aim of this study is to evaluate whether a complex , multifaceted implementation strategy of the low back pain guidelines will reduce secondary care referral and improve patient outcomes compared to the usual simple implementation strategy . Methods / design In a two-armed cluster r and omised trial , 100 general practice s ( clusters ) and 2,700 patients aged 18 to 65 years from the North Denmark region will be included . Practice s are r and omly allocated 1:1 to a simple or a complex implementation strategy . Intervention practice s will receive a complex implementation strategy , including guideline facilitator visits , stratification tools , and quality reports on low back pain treatment . Primary outcome is referral to secondary care . Secondary outcomes are pain , physical function , health-related quality of life , patient satisfaction with care and treatment outcome , employment status , and sick leave . Primary and secondary outcomes pertain to the patient level . Assessment s of outcomes are blinded and follow the intention-to-treat principle . Additionally , a process assessment will evaluate the degree to which the intervention elements will be delivered as planned , as well as measure changes in beliefs and behaviours among general practitioners and patients . Discussion This study provides knowledge concerning the process and effect of an intervention to implement low back pain guidelines in general practice , and will provide insight on essential elements to include in future implementation strategies in general practice .Trial registration Registered as NCT01699256 on Clinical Trials.gov Abstract Psychological factors consistent with fear‐avoidance models are associated with the development of chronic low back pain ( LBP ) . As a result , grade d activity ( GA ) and grade d exposure ( GX ) have been suggested as behavioral treatment options . This clinical trial compared the effectiveness of treatment‐based classification ( TBC ) physical therapy alone to TBC augmented with GA or GX for patients with acute and sub‐acute LBP . Our primary hypothesis was that GX would be most effective for those with elevated pain‐related fear . In total , 108 patients enrolled in this clinical trial and were r and omly assigned to receive TBC , GA , or GX . Outcomes were assessed by a blinded evaluator at 4 weeks and by mail at 6 months . The primary outcomes for this trial were disability and pain intensity , and the secondary outcomes were fear‐avoidance beliefs , pain catastrophizing , and physical impairment . There were no differences in 4‐week and 6‐month outcomes for reduction of disability , pain intensity , pain catastrophizing , and physical impairment . GX and TBC were associated with larger reductions in fear‐avoidance beliefs at 6 months only . Six‐month reduction in disability was associated with reduction in pain intensity , while 6‐month reduction in pain intensity was associated with reductions in fear‐avoidance beliefs and pain catastrophizing . This trial suggests that supplementing TBC with GA or GX was not effective for improving important outcomes related to the development of chronic LBP
Participants believed that there were distinctions between general activity , real/fitness exercise , and medical exercise .
People participating in exercise classes and group work may be more comfortable when matched for abilities and experience .
When an intervention interferes with everyday life and appears to be ineffective or too difficult to implement , people make a reasoned decision to discontinue .
DISCUSSION People are likely to prefer and participate in exercise or training programs and activities that are design ed with consideration of their preferences , circumstances , fitness levels , and exercise experiences
OBJECTIVES The global burden of low back pain is the highest ranked condition contributing to years of living with disability .
Exercise is moderately effective , and adherence to exercise may improve if participants are engaged .
Identification of elements that enhance engagement would enable clinicians to prescribe appropriate interventions .
The review objective was to identify and synthesize qualitative empirical studies that have explored beliefs about exercise therapy of people with nonspecific chronic low back pain .