Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain.
TIKI
1 other identifier
interventional
770
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Sep 2009
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 21, 2012
September 1, 2012
3 years
September 19, 2012
September 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of days off work
12 months
Secondary Outcomes (1)
Disability
12 months
Study Arms (2)
Multidisciplinary intervention
EXPERIMENTALEarly coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
Usual care
ACTIVE COMPARATORIntervention from physiotherapist, chiropractor, rheumatologist and social worker.
Interventions
Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
Eligibility Criteria
You may qualify if:
- Working age adults 18-65
- Low back pain (longer than 2 weeks)
- Sicklisted or at risk
- Employed or unemployed
You may not qualify if:
- Severe comorbidity
- Pregnancy
- Difficulties in reading Danish language
- Application for early retirement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Back and Rehabilitation Center Copenhagen
Copenhagen, Copenhagen, 2100, Denmark
Related Publications (2)
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.
PMID: 36088313DERIVEDFisker 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.
PMID: 23496897DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Petersen, PT, PhD
Back and Rehabilitaion Center Copenhagen
- PRINCIPAL INVESTIGATOR
Annette Fisker, PT, PhDstud
University of Copenhagen, Department of Public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist
Study Record Dates
First Submitted
September 19, 2012
First Posted
September 21, 2012
Study Start
September 1, 2009
Primary Completion
September 1, 2012
Study Completion
October 1, 2014
Last Updated
September 21, 2012
Record last verified: 2012-09