Dataset Information

Resistance training in addition to multidisciplinary rehabilitation for patients with chronic pain in the low back: Study protocol.

ABSTRACT: Introduction:Chronic low back pain (LBP) is a major health problem worldwide. Multidisciplinary rehabilitation and exercise is recommended for the management of chronic LBP. However, there is a need to investigate effective exercise interventions that is available in clinics and as home-based training on a large scale. This article presents the design and rationale of the first randomized clinical trial investigating the effects of progressive resistance training with elastic bands in addition to multidisciplinary rehabilitation for patients with moderate to severe chronic LBP. Methods and analysis:We aim to enroll 100 patients with chronic LBP referred to a specialized outpatient hospital clinic in Norway. Participants will be randomized equally to either; a) 3 tion including whole-body progressive resistance training using elastic bands - followed by home-based progressive resistance training for 9 weeks, or b) 3 weeks of multidisciplinary rehabilitation including general physical exercise - followed by home-based general physical exercise for 9 weeks. Questionnaires and strength tests will be collected at baseline, weeks 3 and 12, and at 6 and 12 months. The primary outcome is between-group changes in pain-related disability at week 12 assessed by the Oswestry disability index. Secondary outcomes include pain, work ability, work status, mental health, health-related quality of life, global rating of change, general health, and muscular strength and pain-related disability up to 12 months of follow-up. Discussion:This study will provide valuable information for clinicians working with patients with chronic LBP. Trial registration:ClinicalTrials.gov, number NCT02420236.

SUBMITTER: Iversen VM

PROVIDER: S-EPMC5936860 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Resistance training in addition to multidisciplinary rehabilitation for patients with chronic pain in the low back: Study protocol.

Iversen Vegard Moe VM Vasseljen Ottar O Mork Paul Jarle PJ Berthelsen Ida Reitan IR Børke Janne-Birgitte Bloch JB Berheussen Gro Falkener GF Tveter Anne Therese AT Salvesen Øyvind Ø Fimland Marius Steiro MS

Contemporary clinical trials communications 20170412

<h4>Introduction</h4>Chronic low back pain (LBP) is a major health problem worldwide. Multidisciplinary rehabilitation and exercise is recommended for the management of chronic LBP. However, there is a need to investigate effective exercise interventions that is available in clinics and as home-based training on a large scale. This article presents the design and rationale of the first randomized clinical trial investigating the effects of progressive resistance training with elastic bands in ad ...[more]

PMID: 29740641

Similar Datasets

Project description:ObjectiveTo assess the long term effects of multidisciplinary biopsychosocial rehabilitation for patients with chronic low back pain.DesignSystematic review and random effects meta-analysis of randomised controlled trials.Data sourcesElectronic searches of Cochrane Back Review Group Trials Register, CENTRAL, Medline, Embase, PsycINFO, and CINAHL databases up to February 2014, supplemented by hand searching of reference lists and forward citation tracking of included trials.Study selection criteriaTrials published in full; participants with low back pain for more than three months; multidisciplinary rehabilitation involved a physical component and one or both of a psychological component or a social or work targeted component; multidisciplinary rehabilitation was delivered by healthcare professionals from at least two different professional backgrounds; multidisciplinary rehabilitation was compared with a non- multidisciplinary intervention.ResultsForty one trials included a total of 6858 participants with a mean duration of pain of more than one year who often had failed previous treatment. Sixteen trials provided moderate quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.21, 95% confidence interval 0.04 to 0.37; equivalent to 0.5 points in a 10 point pain scale) and disability (0.23, 0.06 to 0.40; equivalent to 1.5 points in a 24 point Roland-Morris index) compared with usual care. Nineteen trials provided low quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.51, -0.01 to 1.04) and disability (0.68, 0.16 to 1.19) compared with physical treatments, but significant statistical heterogeneity across trials was present. Eight trials provided moderate quality evidence that multidisciplinary rehabilitation improves the odds of being at work one year after intervention (odds ratio 1.87, 95% confidence interval 1.39 to 2.53) compared with physical treatments. Seven trials provided moderate quality evidence that multidisciplinary rehabilitation does not improve the odds of being at work (odds ratio 1.04, 0.73 to 1.47) compared with usual care. Two trials that compared multidisciplinary rehabilitation with surgery found little difference in outcomes and an increased risk of adverse events with surgery.ConclusionsMultidisciplinary biopsychosocial rehabilitation interventions were more effective than usual care (moderate quality evidence) and physical treatments (low quality evidence) in decreasing pain and disability in people with chronic low back pain. For work outcomes, multidisciplinary rehabilitation seems to be more effective than physical treatment but not more effective than usual care.

Project description:BackgroundThis study investigated the long-term effects (12?months post-rehabilitation) of a standard inpatient multidisciplinary rehabilitation program for patients with chronic low back pain (CLBP), in which a control group (CG) received pain competence training and an intervention group (IG) received combined pain competence and depression prevention training.MethodsIn this prospective control group study with cluster-block randomization, a total of n?=?583 patients were included into per protocol analyses. To examine the effects of rehabilitation on depressive symptoms, pain self-efficacy, and work ability, patients were stratified in repeated-measures analyses of variance by treatment condition (IG vs. CG), level of depressive symptoms (low vs. high), and time of assessment (pre, post, 6, and 12?months after rehabilitation). The impact of each treatment on pain-related days of sick leave (DSL; dichotomized into ? vs. >?2?weeks) was determined separately by conducting non-parametric analyses. Multiple imputations (n?=?1225) confirmed the results. Effects were interpreted if clinical significance was given.ResultsOnly patients with high levels of depressive symptoms showed long-term improvements in depressive symptoms and self-efficacy. Long-term improvements in work ability index and mental work ability item were restricted to the IG. Furthermore, long-term effects on pain-related DSL were ascertained by per protocol and multiple imputation analyses only for the IG.ConclusionsPatients with high levels of depressive symptoms showed improvements in depressive symptoms and self-efficacy, supporting the psychological effectiveness of both interventions. However, the beneficial long-term effects of rehabilitation on work ability and pain-related DSL among the IG support implementation of combined pain competence and depression prevention training.Trial registrationDRKS00015465 (German Clinical Trial Register DRKS); date of registration: 03.09.2018.

Project description:In Germany, a multidisciplinary rehabilitation named "behavioural medical rehabilitation" (BMR) is available for treatment of chronic low back pain (clbp). A central component of BMR is standard exercise therapy (SET), which is directed mainly to improve physical fitness. There is a need to address psychosocial factors within SET and therefore to improve behavior change with a focus on the development of self-management skills in dealing with clbp. Furthermore, short-term effectiveness of BMR with a SET has been proven, but the impact of a behavioural exercise therapy (BET) for improvement of the long-term effectiveness of BMR is unclear.To compare the effectiveness of two exercise programs with different approaches within BMR on the effects of BMR a prospective randomized controlled trial (RCT) in two rehabilitation centres will be performed. 214 patients aged 18-65 with clbp will be, based on an "urn randomisation"-algorithm, randomly assigned to a BMR with SET (function-oriented, n=107) and BMR with BET (behaviour-oriented, n=107). Both exercise programs have a mean duration of 26 hours in three weeks and are delivered by a limited number of not-blinded study therapists in closed groups with six to twelve patients who will be masked regarding study group. The main differences of BET lie in its detailed manualised program with a theory-based, goal-orientated combination of exercise, education and behavioural elements, active participation of patients and consideration of their individual preferences and previous experiences with exercise. The primary outcome is functional ability assessed with the Hannover Functional Ability Questionnaire directly before and after the rehabilitation program, as well as a six and twelve-month follow-up.This RCT is designed to explore the effects of BET on the effectiveness of a BMR compared to a BMR with SET in the management of patients with clbp. Methodological challenges arise from conducting a RCT within routine health care as well as from ensuring high treatment integrity. Findings of this study might contribute to a better understanding of the mechanism of action of BMR and the special effects of BET and may be used to improve the quality of these interventions in routine care, therefore reducing the burden to patients with disabling clbp.Current controlled trials NCT01666639.

Project description:BackgroundThe long-term effects of behavioural medical rehabilitation (BMR), as a type of multidisciplinary rehabilitation, in the treatment of chronic non-specific low back pain (CLBP) have been shown. However, the specific effects of behavioural exercise therapy (BET) compared to standard exercise therapy (SET) within BMR are not well understood. The aim of the study was to assess the effectiveness of BMR + BET compared to BMR + SET in individuals with CLBP in a two-armed, pre-registered, multicentre, parallel, randomised controlled trial (RCT).MethodsA total of 351 adults with CLBP in two rehabilitation centres were online randomised based on an 'urn randomisation' algorithm to either BMR + SET (n = 175) or BMR + BET (n = 176). Participants in both study groups were non-blinded and received BMR, consisting of an multidisciplinary admission, a psychosocial assessment, multidisciplinary case management, psychological treatment, health education and social counselling. The intervention group (BMR + BET) received a manualised, biopsychosocial BET within BMR. The aim of BET was to develop self-management strategies in coping with CLBP. The control group (BMR + SET) received biomedical SET within BMR with the aim to improve mainly physical fitness. Therapists in both study groups were not blinded. The BMR lasted on average 27 days, and both exercise programmes had a mean duration of 26 h. The primary outcome was functional ability at 12 months. Secondary outcomes were e.g. pain, avoidance-endurance, pain management and physical activity. The analysis was by intention-to-treat, blinded to the study group, and used a linear mixed model.ResultsThere were no between-group differences observed in function at the end of the BMR (mean difference, 0.08; 95% CI - 2.82 to 2.99; p = 0.955), at 6 months (mean difference, - 1.80; 95% CI; - 5.57 to 1.97; p = 0.349) and at 12 months (mean difference, - 1.33; 95% CI - 5.57 to 2.92; p = 0.540). Both study groups improved in the primary outcome and most secondary outcomes at 12 months with small to medium effect sizes.ConclusionBMR + BET was not more effective in improving function and other secondary outcomes in individuals with CLBP compared to BMR + SET.Trial registrationCurrent controlled trials NCT01666639 , 16/08/2012.

Dataset Information

Resistance training in addition to multidisciplinary rehabilitation for patients with chronic pain in the low back: Study protocol.

Publications

Resistance training in addition to multidisciplinary rehabilitation for patients with chronic pain in the low back: Study protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure