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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

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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

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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:BackgroundLow back pain (LBP) is the leading cause of disability worldwide. Physical exercise, as a treatment, is beneficial for the improvement of quality of life in patients with LBP, and it is widely accepted.ObjectiveWe aimed to develop a protocol for a feasibility study that is designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors among patients with chronic LBP after 8 weeks of randomization.MethodsThis is a study protocol for a randomized controlled trial that will consist of individuals with chronic LBP who are aged between 18 and 65 years. Participants will be allocated, through block randomization, to one of the following groups: the motor control exercises (MCEs), pain education, MCEs+pain education, and usual care groups. The primary outcome will be pain intensity, and the secondary outcomes will be the pressure pain threshold, which will be measured with a digital algometer; LBP-related disability; fears and beliefs; the fear of movement; quality of life; mood states; and levels of depression and anxiety. The trial was approved by the ethics committee for research involving human beings of the Federal University of Pelotas (reference number: 5.717.390) in September 2022, and it will be conducted until August 2023.ResultsThe researchers are being trained to apply the questionnaires and carry out the interventions. Patient recruitment will begin at the end of 2022 and results are expected to be achieved by August 2023.ConclusionsOur trial will provide preliminary data regarding the feasibility and safety of MCEs and pain education for patients with LBP. It will also provide preliminary outcome data that can be used to identify the most efficient intervention and the level of health care that should be implemented in public health services.Trial registrationBrazilian Registry of Clinical Trials U1111-1221-4106; https://ensaiosclinicos.gov.br/rg/RBR-2xx2r2/.International registered report identifier (irrid)PRR1-10.2196/31345.

Project description:BackgroundIn 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.Methods/designTo 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.DiscussionThis 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.Trial registrationCurrent controlled trials NCT01666639.

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

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

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