Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. (TIKI)
Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Recruiting
- Back and Rehabilitation Center Copenhagen
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Principal Investigator:
- Tom Petersen, PT, PhD
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Contact:
- Tom Petersen, PT, PhD
- Phone Number: +4535304974
- Email: tom.petersen@suf.kk.dk
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Contact:
- Inge Lis Goethgen, Head
- Phone Number: +4535304950
- Email: MW53@suf.kk.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multidisciplinary intervention
Early coordinated multidisciplinary intervention.
Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
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Early coordinated multidisciplinary intervention.
Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
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Active Comparator: Usual care
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
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Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of days off work
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Disability
Time Frame: 12 months
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12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Tom Petersen, PT, PhD, Back and Rehabilitaion Center Copenhagen
- Principal Investigator: Annette Fisker, PT, PhDstud, University of Copenhagen, Department of Public Health
Publications and helpful links
General Publications
- Fisker A, Langberg H, Petersen T, Mortensen OS. Effects of an early multidisciplinary intervention on sickness absence in patients with persistent low back pain-a randomized controlled trial. BMC Musculoskelet Disord. 2022 Sep 10;23(1):854. doi: 10.1186/s12891-022-05807-7.
- Fisker A, Langberg H, Petersen T, Mortensen OS. Early coordinated multidisciplinary intervention to prevent sickness absence and labour market exclusion in patients with low back pain: study protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2013 Mar 13;14:93. doi: 10.1186/1471-2474-14-93.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-C-2008-112
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