Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. (TIKI)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Low Back Pain |
Procedure: Multidisciplinary intervention Procedure: Usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial |
- Number of days off work [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Disability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 770 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | October 2014 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Multidisciplinary intervention
Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
|
Procedure: Multidisciplinary intervention
Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
|
|
Active Comparator: Usual care
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
|
Procedure: Usual care
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Tom Petersen, PT, PhD | +4535304974 | tom.petersen@suf.kk.dk |
| Contact: Inge Lis Goethgen, Head | +4535304950 | MW53@suf.kk.dk |
| Denmark | |
| Back and Rehabilitation Center Copenhagen | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Tom Petersen, PT, PhD +4535304974 tom.petersen@suf.kk.dk | |
| Contact: Inge Lis Goethgen, Head +4535304950 MW53@suf.kk.dk | |
| Principal Investigator: Tom Petersen, PT, PhD | |
| Principal Investigator: | Tom Petersen, PT, PhD | Back and Rehabilitaion Center Copenhagen |
| Principal Investigator: | Annette Fisker, PT, PhDstud | University of Copenhagen, Department of Public Health |
More Information
Additional Information:
No publications provided by Back and Rehabilitation Center, Copenhagen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Tom Petersen, Physiotherapist, Back and Rehabilitation Center, Copenhagen |
| ClinicalTrials.gov Identifier: | NCT01690234 History of Changes |
| Other Study ID Numbers: | H-C-2008-112 |
| Study First Received: | September 19, 2012 |
| Last Updated: | September 19, 2012 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Back and Rehabilitation Center, Copenhagen:
|
Low back pain Return to work Sickness absence Rehabilitation Multidisciplinary intervention |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013