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The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

ABSTRACT: Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care.This is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care. Secondary GP outcomes include beliefs about pain and impairment, GP confidence, and actual and reported clinical behaviour. Health economic and process evaluations will be conducted.In the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care.Australian New Zealand Clinical Trials Registry, ACTRN12616000888460 . Registered on 6 July 2016.

SUBMITTER: Darlow B

PROVIDER: S-EPMC5646107 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

Darlow Ben B Stanley James J Dean Sarah S Abbott J Haxby JH Garrett Sue S Mathieson Fiona F Dowell Anthony A

Trials 20171017 1

<h4>Background</h4>Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psycho ...[more]

PMID: 29041947

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Project description:BACKGROUND:Effective and cost-effective primary care treatments for low back pain (LBP) are required to reduce the burden of the world's most disabling condition. This study aimed to compare the clinical effectiveness and cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach to LBP (intervention) with usual general practitioner (GP) care (control). METHODS AND FINDINGS:This pragmatic, cluster-randomised controlled trial with process evaluation and parallel economic evaluation was conducted in the Hutt Valley, New Zealand. Eight general practices were randomly assigned (stratified by practice size) with a 1:1 ratio to intervention (4 practices; 34 GPs) or control group (4 practices; 29 GPs). Adults presenting to these GPs with LBP as their primary complaint were recruited. GPs in the intervention practices were trained in the FREE approach, and patients presenting to these practices received care based on the FREE approach. The FREE approach restructures LBP consultations to prioritise early identification and management of barriers to recovery. GPs in control practices did not receive specific training for this study, and patients presenting to these practices received usual care. Between 23 September 2016 and 31 July 2017, 140 eligible patients presented to intervention practices (126 enrolled) and 110 eligible patients presented to control practices (100 enrolled). Patient mean age was 46.1 years (SD 14.4), and 46% were female. The duration of LBP was less than 6 weeks in 88% of patients. Primary outcome was change from baseline in patient participant Roland Morris Disability Questionnaire (RMDQ) score at 6 months. Secondary patient outcomes included pain, satisfaction, and psychosocial indices. GP outcomes included attitudes, knowledge, confidence, and GP LBP management behaviour. There was active and passive surveillance of potential harms. Patients and outcome assessors were blind to group assignment. Analysis followed intention-to-treat principles. A total of 122 (97%) patients from 32 GPs in the intervention group and 99 (99%) patients from 25 GPs in the control group were included in the primary outcome analysis. At 6 months, the groups did not significantly differ on the primary outcome (adjusted mean RMDQ score difference 0.57, 95% CI -0.64 to 1.78; p = 0.354) or secondary patient outcomes. The RMDQ difference met the predefined criterion to indicate noninferiority. One control group participant experienced an activity-related gluteal tear, with no other adverse events recorded. Intervention group GPs had improvements in attitudes, knowledge, and confidence compared with control group GPs. Intervention group GP LBP management behaviour became more guideline concordant than the control group. In cost-effectiveness, the intervention dominated control with lower costs and higher Quality-Adjusted Life Year (QALY) gains. Limitations of this study were that although adequately powered for primary outcome assessment, the study was not powered for evaluating some employment, healthcare use, and economic outcomes. It was also not possible for research nurses (responsible for patient recruitment) to be masked on group allocation for practices. CONCLUSIONS:Findings from this study suggest that the FREE approach improves GP concordance with LBP guideline recommendations but does not improve patient recovery outcomes compared with usual care. The FREE approach may reduce unnecessary healthcare use and produce economic benefits. Work participation or health resource use should be considered for primary outcome assessment in future trials of undifferentiated LBP. TRIAL REGISTRATION:ACTRN12616000888460.

Project description:INTRODUCTION:Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS:The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION:This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER:ACTRN12617001288314.

Project description:IntroductionExercise therapy is the most recommended treatment for chronic low back pain (LBP). Effect sizes for exercises are usually small to moderate and could be due to the heterogeneity of people presenting with LBP. Thus, if patients could be better matched to exercise based on individual factors, then the effects of treatment could be greater. A recently published study provided evidence of better outcomes when patients are matched to the appropriate exercise type. The study demonstrated that a 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to one of the two exercise approaches for LBP (motor control and graded activity). The primary aim of the current study isill be to evaluate whether preidentified baseline characteristics, including the LSIQ, can modify the response to two of the most common exercise therapies for non-specific LBP. Secondary aims include an economic evaluations with a cost-effectiveness analysis.Methods and analysisParticipants (n=414) will be recruited by primary care professionals and randomised (1:1) to receive motor control exercises or graded activity. Participants will undergo 12 sessions of exercise therapy over an 8-week period. The primary outcome will be physical function at 2 months using the Oswestry Disability Index. Secondary outcomes will be pain intensity, function and quality of life measured at 2, 6 and 12 months. Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitisation. We will construct linear mixed models with terms for participants (fixed), treatment group, predictor (potential effect modifier), treatment group×predictor (potential effect modifier), physiotherapists, treatment group×physiotherapists and baseline score for the dependent variable.Ethics and disseminationThis study received ethics approval from the Hamilton Integrate Research Ethics Board. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04283409.

Project description:BACKGROUND:Atraumatic lower limb amputation is a life-changing event for approximately 185,000 persons in the United States each year. A unilateral amputation is associated with rapid changes to the musculoskeletal system including leg and back muscle atrophy, strength loss, gait asymmetries, differential mechanical joint loading and leg length discrepancies. Even with high-quality medical care and prostheses, amputees still develop secondary musculoskeletal conditions such as chronic low back pain (LBP). Resistance training interventions that focus on core stabilization, lumbar strength and dynamic stability during loading have strong potential to reduce LBP and address amputation-related changes to the musculoskeletal system. Home-based resistance exercise programs may be attractive to patients to minimize travel and financial burdens. METHODS/DESIGN:This study will be a single-assessor-blinded, pre-post-test randomised controlled trial involving 40 men and women aged 18-60 years with traumatic, unilateral transtibial amputation. Participants will be randomised to a home-based, resistance exercise group (HBRX) or a wait-list control group (CON). The HBRX will consist of 12 weeks of elastic resistance band and bodyweight training to improve core and lumbopelvic strength. Participants will be monitored via Skype or Facetime on a weekly basis. The primary outcome will be pain severity (11-point Numerical Pain Rating Scale; NRSpain). Secondary outcomes will include pain impact on quality of life (Medical Outcomes Short Form 36, Oswestry Disability Index and Roland Morris Disability Questionnaire), kinematics and kinetics of walking gait on an instrumented treadmill, muscle morphology (muscle thickness of multifidus, transversus abdominis, internal oblique), maximal muscle strength of key lumbar and core muscles, and daily step count. DISCUSSION:The study findings will determine whether a HBRX program can decrease pain severity and positively impact several physiological and mechanical factors that contribute to back pain in unilateral transtibial amputees with chronic LBP. We will determine the relative contribution of the exercise-induced changes in these factors on pain responsiveness in this population. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03300375 . Registered on 2 October 2017.

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The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

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The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

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