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The Sano study: justification and detailed description of a multidisciplinary biopsychosocial rehabilitation programme in patients with chronic low back pain.

ABSTRACT: OBJECTIVE::To justify and describe an integrated rehabilitation programme for patients with chronic low back pain prior to evaluation in a randomized controlled trial. METHOD::The Template for Intervention Description and Replication (TIDieR) checklist was used as a structural framework for the description of the integrated rehabilitation programme. As a part of the description, the Medical Research Council guidance, 'Developing and evaluating complex interventions', was used as a framework to justify the integrated rehabilitation programme. INTERVENTION DESCRIPTION::The integrated rehabilitation programme adopts a participatory biopsychosocial approach integrating inpatient activities supported by a multidisciplinary team and learning located within the patient's own environment. The integrated rehabilitation programme comprises 3?weeks of inpatient stay and 11?weeks of home-based activities. The inpatient part of the programme consists of 38 clinical activities, some of them delivered more than once. The 38 clinical activities were described in an activity sheet developed for this purpose, combining five items from the TIDieR. CONCLUSION::An integrated rehabilitation programme for patients with chronic low back pain has been justified and described. The intervention description is currently being used for successful structuring and standardization of the content and delivery of the integrated rehabilitation programme in a randomized controlled trial. TRAIL REGISTRATION::ClinicalTrials.gov: NCT02884466.

SUBMITTER: Schmidt AM

PROVIDER: S-EPMC6204649 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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The Sano study: justification and detailed description of a multidisciplinary biopsychosocial rehabilitation programme in patients with chronic low back pain.

Schmidt Anne Mette AM Terkildsen Maindal Helle H Laurberg Trine Bay TB Schiøttz-Christensen Berit B Ibsen Charlotte C Bak Gulstad Kirstine K Maribo Thomas T

Clinical rehabilitation 20180608 11

<h4>Objective:</h4>To justify and describe an integrated rehabilitation programme for patients with chronic low back pain prior to evaluation in a randomized controlled trial.<h4>Method:</h4>The Template for Intervention Description and Replication (TIDieR) checklist was used as a structural framework for the description of the integrated rehabilitation programme. As a part of the description, the Medical Research Council guidance, 'Developing and evaluating complex interventions', was used as a ...[more]

PMID: 29879847

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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:BACKGROUND:Chronic low back pain (LBP) is a leading cause of disability worldwide. Biopsychosocial rehabilitation programs have been advocated for its management, especially since the widespread acceptance of the biopsychosocial model of chronic pain. Despite extensive evidence of its short-term benefits, few studies have reported on its long-term effect and more specifically on indirect outcomes such as return to work and quality of life (QoL). The present study evaluated the long-term effect of a multidisciplinary biopsychosocial rehabilitation (MBR) program for patients with chronic LBP, for which short- and intermediate-term efficacy had been established, with an emphasis on recovering work capability. METHODS:This prospective cohort study enrolled 201 patients on a four-week MBR program incorporating physical and occupational therapies and psychological counselling. Assessments occurred at program admission and discharge and at 6 and 18 months. Work capability, Oswestry Disability Index, Tampa Scale for Kinesiophobia, Core Outcome Measures Index (COMI), and Hospital Anxiety and Depression Scale were assessed. Multiple mixed models were used to detect changes in each outcome. Logistic regressions were calculated to identify predictors of recovery of work capability. RESULTS:Of the 201 patients who fulfilled the eligibility criteria, 160 (79.8%) attended the discharge assessment, 127 (63.2%) attended the 6-month follow-up, and 107 (53.3%) continued to the 18-month follow-up. Initially, 128 patients (71.5%) had been on sick leave. At 6 and 18 months, 72 (56.7%) and 84 (78.5%) participants had recovered their work capability, respectively. There were significant improvements in pain, disability, kinesiophobia, and anxiety and depression scores over time. Patients who recovered work capability showed significantly greater improvements in their total COMI score, general QoL, and disability, which were the best three predictors of recovering work capability. CONCLUSIONS:This study extends previous results confirming the program's contribution to recovering work capability among chronic LBP patients.

Project description:Improvement of the long-term effectiveness of multidisciplinary ortho-paedic rehabilitation (MOR) in the management of chronic non-specific low back pain (CLBP) remains a central issue for health care in Germany. We developed an interprofessional and interdisciplinary, biopsychosocial rehabilitation concept named "PASTOR" to promote self-management in adults with CLBP and compared its effectiveness with the current model of MOR.A multicentre quasi-experimental study with three measurement time points was implemented. 680 adults aged 18 to 65 with CLBP were assed for eligibil-ity in three inpatient rehabilitation centres in Germany. At first the effects of the MOR, with a total extent of 48 hours (control group), were assessed. Thereafter, PASTOR was implemented and evaluated in the same centres (intervention group). It consisted of six interprofessional modules, which were provided on 12 days in fixed groups, with a total extent of 48 hours. Participants were assessed with self-report measures at baseline, discharge, and 12 months for functional ability (primary outcome) using the Hannover Functional Ability Questionnaire (FFbH-R) and vari-ous secondary outcomes (e.g. pain, health status, physical activity, pain coping, pain-related cognitions).In total 536 participants were consecutively assigned to PASTOR (n=266) or MOR (n=270). At 12 months, complete data of 368 participants was available. The adjusted between-group difference in the FFbH-R at 12 months was 6.58 (95% CI 3.38 to 9.78) using complete data and 3.56 (95% CI 0.45 to 6.67) using available da-ta, corresponding to significant small-to-medium effect sizes of d=0.42 (p<0.001) and d=0.10 (p=0.025) in favour of PASTOR. Further improvements in secondary out-comes were also observed in favour of PASTOR.The interprofessional and interdisciplinary, biopsychosocial rehabilita-tion program PASTOR shows some improvements of the long-term effectiveness of inpatient rehabilitation in the management of adults with CLBP. Further insights into mechanisms of action of complex intervention programs are required.ClinicalTrials.gov NCT02056951.

Dataset Information

The Sano study: justification and detailed description of a multidisciplinary biopsychosocial rehabilitation programme in patients with chronic low back pain.

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The Sano study: justification and detailed description of a multidisciplinary biopsychosocial rehabilitation programme in patients with chronic low back pain.

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