Comparison of Two Multidisciplinary Rehabilitation Interventions in Patients With Chronic Low Back Pain

January 27, 2020 updated by: Sano

Comparison of Two Multidisciplinary Rehabilitation Interventions in Patients With Chronic Low Back Pain - A Randomised Controlled Clinical Trial

Introduction Chronic low back pain (CLBP) is a highly prevalent health condition, and the leading cause of years lived with disability. The high prevalence causes a substantial impact on patients, communities and health-care systems. There is a continuing challenge to offer evidence-based rehabilitation for patients with CLBP. There is a lack of studies on adequate follow-up approaches to maintain successful treatment. No earlier study has assessed if the positive treatment effects of a multidisciplinary rehabilitation intervention can be maintained with an intervention alternating between inpatient interventions and home-based activities.

Aim To assess if a novel multidisciplinary rehabilitation intervention is more effective in maintaining successful treatment after 6 months, than a usual multidisciplinary rehabilitation intervention in patients with CLBP.

The novel intervention is a 14-week program alternating between in total three weeks of inpatient intervention and home-based activities. This alternation allows the participants time and opportunity to adapt and transfer inpatient learning to activities and participation in their own environment in interaction with everyday life situations and surroundings. Usual care is a four-week inpatient intervention. It is hypothesized that the intervention will be superior to usual care.

Method The study will be conducted at The Danish Rheumatism Associations' rehabilitation centre Sano Aarhus. 160 participants with CLBP will be randomly allocated to one of two groups. The novel intervention consists of: 1) a pre-admission day, 2) two weeks of home-based activities, 3) two-week inpatient period, 4) four weeks of home-based activities, 5) 1st two-days inpatient follow-up, 6) six weeks of home-based activities and 7) 2nd two-days inpatient follow-up. Usual care consists of a four-week inpatient intervention.

The two groups will be compared according to disability, pain, pain self-efficacy, quality of life, depression and exercise capacity.

Relevance The present study has emerged out of the fields where patients, clinicians and researchers intersect and is consequently highly clinically relevant. If positive treatment effects can be maintained or even improved in the long term, the results may serve as inspiration for the design of multidisciplinary rehabilitation interventions in clinical practice; this will be valuable for future patients with CLBP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Chronic low back pain (CLBP) is a highly prevalent health condition, and the leading cause of years lived with disability both globally and in Denmark. In the majority of patients with CLBP, no underlying pathology or cause can be identified and CLBP is acknowledged to be multifactorial.

CLBP is defined by symptoms lasting for a period longer than three months. The high prevalence of CLBP causes a substantial impact on patients and their families, communities and health-care systems, as well as a financial burden. Besides pain and disability people with CLBP often experience psychosocial consequences with signs of anxiety and depression and effects on social, leisure, and work life. Recognition of the physical, psychological and social consequences of CLBP led to the development of the widely accepted biopsychosocial model in the understanding and managing of CLBP.

The World Health Organization's (WHO) International Classification of Functioning, Disability and Health (ICF) provides a framework for applying the biopsychosocial model into clinical practice, especially into rehabilitation. By emphasizing, that disability is a dynamic interaction between the dimensions of body function, activity, participation, and environmental and personal factors, ICF helps treating the patients rather than only their low back pain by addressing all the biopsychosocial dimensions of their disability.

Disability itself arises through complex and multi-factorial mechanisms and therefore, rehabilitation processes are defined as complex health interventions undertaken in a complex environment. Rehabilitation is rather a process than a treatment or specific action, and a multidisciplinary team most effectively manages the complex problems seen in rehabilitation. Rehabilitation has many potential active ingredients, and combining the different components in a whole is more than the sum of its parts.

There is a continuing challenge to offer evidence-based rehabilitation for patients with CLBP. A systematic review by Kamper identified and assessed risk of bias in 12 randomized controlled trials (RCT's) comparing two multidisciplinary rehabilitation interventions. In March 2016 we performed an updated literature search in PubMed identical to that of the review and identified one additional RCT comparing two multidisciplinary interventions. Risk of bias in the additional study was assessed using Cochrane risk of bias tool (The Cochrane Collaboration ) identical to the review.

Nine of the 13 studies had disability and pain as primary or secondary outcome. The multidisciplinary interventions being compared varied across the nine studies in content and/or time frame. As the studies were very heterogenic, a pooled comparison and description was not possible. Overall the nine studies showed that multidisciplinary rehabilitation had a positive effect on disability and pain in the short and medium term, but there were discrepancy in the studies whether the effect can be maintained in the long term. A literature search identified two studies on follow-up care. One study tested the effect of multidisciplinary rehabilitation with subsequent booster sessions conducted by telephone within 12 months after discharge, and found only slight advantages, but no statistical significance of the booster sessions. The other study compared a 3-month exercise follow-up program and routine follow-up on patients with CLBP who had completed a 3-week outpatient multidisciplinary rehabilitation program. Favourable outcomes after one year were observed in both groups, but only patients attending the exercise follow-up program improved in disability.

There is a lack of studies on adequate follow-up approaches to maintain successful treatment. No earlier study has assessed if the positive treatment effects of a multidisciplinary rehabilitation intervention can be maintained with an intervention alternating between inpatient interventions and home-based activities.

Aim To assess if a novel multidisciplinary rehabilitation intervention is more effective in maintaining successful treatment after 6 months, than a usual multidisciplinary rehabilitation intervention in patients with chronic low back pain.

The novel intervention is a 14-week program alternating between in total three weeks of inpatient intervention and home-based activities. This alternation will allow the participants time and opportunity to adapt and transfer inpatient learning to activities and participation in their own environment in interaction with everyday life situations and surroundings. Furthermore, the novel intervention will consist of a higher degree of patient involvement than the usual intervention. Usual care is a four-week inpatient intervention.

Objectives (i) To compare changes in the two multidisciplinary rehabilitation groups on disability, pain, pain self-efficacy, quality of life, anxiety/depression and exercise capacity.

(ii) To examine the association between changes in disability versus changes in pain, pain self-efficacy, quality of life, anxiety/depression and exercise capacity.

Hypotheses (i) The intervention group will experience a five points larger improvement in Oswestry Disability Index compared to usual care. Furthermore, the intervention group will experience a larger improvement in pain, pain self-efficacy, quality of life, anxiety/depression and exercise capacity compared to usual care.

(ii) There is negative association between changes in disability and quality of life, pain self-efficacy and exercise capacity, respectively. There is a positive association between disability and pain and anxiety/depression, respectively. The strongest association will be between disability and pain self-efficacy.

Materials and methods Study setting All participants will be recruited from, treated and tested at Sano Aarhus, Denmark. A rheumatologist will perform the selection of participants based on the clinical problem of referral.

Randomization An independent administrative assistant will perform a randomly allocated computer-generated randomization of participants into either intervention or control group. Stratified randomization on the basis of Oswestry Disability Index score below and above 40 will be used in order to achieve approximate balance of disability in the two groups. 1:1 allocation in blocks of 6 will be used. Due to waiting time, randomization will take place in average 5-6 months before study start.

Blinding As both interventions will be performed in the same physical setting at the same time, blinding of participants and intervening clinicians will not be possible due to knowledge of content and duration of the intervention the participants are allocated to. Intervening clinicians involved in the treatment of both groups will assess physical status of the participants. In order to raise equal expectations, participants will be blinded to the study hypothesis by telling them the RCT is intended to compare two equal multidisciplinary rehabilitation interventions both meeting current scientific standards and appropriate to improve health status.

The researchers involved in the statistical analyses will be blinded to treatment groups.

Sample size Oswestry Disability Index was used for sample size calculation. Based on data from the literature and a pilot study on 25 patients with CLBP from Sano, mean change is estimated to 10 in the intervention group and 5 in the control group, and the standard deviation on the changes is estimated to 10. Using 80% power and a significance level of 0.05, 64 participants will be required in each group. A dropout rate of 20% is estimated, for what reason it will be planned to recruit a total of 160 participants.

Interventions The content of both interventions will be described in details in a study protocol as recommended for complex interventions.

Both groups will be managed by the same multidisciplinary staff in the same physical setting at the same time. Participants in the two groups will inevitably meet each other, and thus both they and the multidisciplinary staff will have the opportunity to compare and discuss the different rehabilitation interventions. Despite the possible overflow between the two rehabilitation interventions, the present parallel design has been preferred rather than a staggered design where waiting time and external circumstances would have been different between the two groups.

Data collection Demographics and PROMs will be collected before the randomization (baseline), and due to 5-6 months of waiting time again at the beginning of the inpatient rehabilitation intervention (intervention start). Exercise capacity test performed by a trained physiotherapist using a standardized protocol, and clinical and neurological findings collected by an experienced rheumatologist using a standardized examination protocol, will be collected at the first inpatient contact.

Follow-up data will be collected at the end of the inpatient rehabilitation intervention, at each follow-up (intervention group) and at 6 and 12 months. Participants dropping out will be asked to fill in the PROMs at 6 months.

Participants enter data directly in a database via a link. In order to minimize missing data a reminder will be send via email after one week. If participants are unable to fill out the electronic versions, an independent administrative assistant will enter data from a paper copy of the questionnaires.

Perspective The present study has emerged out of the fields where patients, clinicians and researchers intersect and is consequently highly clinically relevant. If positive treatment effects can be maintained or even improved in the long term, the results may serve as inspiration for the design of multidisciplinary rehabilitation interventions in clinical practice; this will be valuable for future patients with CLBP.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • low back pain for more than 12 months with or without sciatica and/or with or without generalized pain identified by ICD-10 codes
  • Oswestry Disability score > 20.

Exclusion Criteria:

  • a rated physical status of > 3 according to the American Society of Anesthesiologists Physical Status Classification System
  • axial spondyloarthritis
  • spinal fracture within the last 3 months
  • severe osteoporosis
  • active cancer
  • active psychiatric pathology assessed by general practitioner before referral
  • pregnancy
  • low Danish language skills.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The intervention group will receive a multidisciplinary rehabilitation intervention consisting of: 1) a pre-admission day, 2) two weeks of home-based activities, 3) two-week inpatient period, 4) four weeks of home-based activities, 5) 1st two-days inpatient follow-up, 6) six weeks of home-based activities and 7) 2nd two-days inpatient follow-up.
Behavioral: Multidisciplinary rehabilitation intervention
Both groups will receive examination and medicine adjustment from a rheumatologist, and treatment from physiotherapist, occupational therapist and nursing staff, respectively. The multidisciplinary rehabilitation intervention in both groups will be based on the biopsychosocial model of illness. The inpatient stays of 8-10 hours per day will consist of 1) group tuition, 2) group and individual treatment and 3) unassisted training sessions.
Active Comparator: Usual care group
The usual care group will receive a four-week inpatient multidisciplinary rehabilitation intervention.
Behavioral: Multidisciplinary rehabilitation intervention
Both groups will receive examination and medicine adjustment from a rheumatologist, and treatment from physiotherapist, occupational therapist and nursing staff, respectively. The multidisciplinary rehabilitation intervention in both groups will be based on the biopsychosocial model of illness. The inpatient stays of 8-10 hours per day will consist of 1) group tuition, 2) group and individual treatment and 3) unassisted training sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Oswestry Disability Index
Time Frame: 28 months
28 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Numerical Rating Scale
Time Frame: 28 months
28 months
The Pain Self-Efficacy Questionnaire
Time Frame: 28 months
28 months
EQ-5D
Time Frame: 28 months
28 months
Major Depression Inventory
Time Frame: 28 months
28 months
Aastrands cycle test
Time Frame: 28 months
28 months
Three questions on physical activity
Time Frame: 28 months
28 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sano

Investigators

  • Principal Investigator: Anne Mette Schmidt, MSc, Sano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (Estimate)

August 31, 2016

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sano 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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