Comparison of Two Multidisciplinary Rehabilitation Interventions in Patients With Chronic Low Back Pain - A Randomised Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 165
- Primary Endpoint
- The Oswestry Disability Index
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
The Oswestry Disability Index
Time Frame: 28 months
Secondary Outcomes
- Numerical Rating Scale(28 months)
- The Pain Self-Efficacy Questionnaire(28 months)
- Major Depression Inventory(28 months)
- Three questions on physical activity(28 months)
- EQ-5D(28 months)
- Aastrands cycle test(28 months)