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

Low Back Pain Clinical Trial

— TIKI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01690234
• Other study ID #: H-C-2008-112
• Status: Recruiting
• Phase: N/A
• First received: September 19, 2012
• Last updated: September 19, 2012
• Start date: September 2009
• Est. completion date: October 2014

Study information

• Verified date: September 2012
• Source: Back and Rehabilitation Center, Copenhagen
• Contact: Tom Petersen, PT, PhD
• Phone: +4535304974
• Email: tom.petersen[@]suf.kk.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 770
• Est. completion date: October 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• Multidisciplinary intervention
Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
• Usual care
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.

Locations

Country	Name	City	State
Denmark	Back and Rehabilitation Center Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Back and Rehabilitation Center, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days off work		12 months	Yes
Secondary	Disability		12 months	Yes