Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain.

Study Overview
=================
Brief Summary
-----------------
In Denmark the number of patients, sick listed for more than four weeks is increasing, and patients suffering from musculoskeletal disorders make one third of the total amount of long-term absenteeism. Compared to other diagnoses, patients suffering from musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. The aim of this study is to evaluate the effect of a work oriented multidisciplinary intervention. A randomized controlled trial will include 770 patients with low back pain. The study population consists of patients, who are sick listed or at risk of sick leave due to LBP. The control group is treated with usual care in a team with participation of a physiotherapist, a chiropractor, a rheumatologist and a local employed social worker The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist and a social worker from the local sickness benefit office. The treating physiotherapist will be the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days of work. Secondary outcomes are disability, pain, and quality of life. This large RCT study is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the sickness benefit office participating in team meetings.

Official Title
-----------------
Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Procedure: Multidisciplinary intervention
* Procedure: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Working age adults 18-65 Low back pain (longer than 2 weeks) Sicklisted or at risk Employed or unemployed Exclusion Criteria: Severe comorbidity Pregnancy Difficulties in reading Danish language Application for early retirement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidisciplinary intervention<br>Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager. | Procedure: Multidisciplinary intervention<br>* Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.<br>|
| Active Comparator: Usual care<br>Intervention from physiotherapist, chiropractor, rheumatologist and social worker. | Procedure: Usual care<br>* Intervention from physiotherapist, chiropractor, rheumatologist and social worker.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days off work |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low back pain, Return to work, Sickness absence, Rehabilitation, Multidisciplinary intervention