This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
4Get in touch
More info
You can access this
clinical trial
if you have
Low Back Pain
and you are
over 18
years old
The phase for this study is not defined.
Show me locations

The purpose

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.

Provided treatments

  • Behavioral: Multidisciplinary rehabilitation intervention

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02884466. The sponsor of the trial is Sano and it is looking for 165 volunteers for the current phase.
Official trial title:
Comparison of Two Multidisciplinary Rehabilitation Interventions in Patients With Chronic Low Back Pain - A Randomised Controlled Clinical Trial