- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00741650
Ibedrift- A Trial Comparing a New Approach to Musculoskeletal Pain Consisting of Education and Peer Involvement to Treatment as Usual (Ibedrift)
Ibedrift- Health Related Coping. A Randomized Controlled Trial Comparing a Worksite Educational Intervention With or Without Referral to Treatment as Usual.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the study is to systematically test a new treatment method for musculoskeletal pain in Norway. The intervention focuses on attempting to treat musculoskeletal pain outside the traditional medical system as much as possible, to avoid the establishment of a patient identity and passive patient behavior. In addition, participants are given reasons to stay active, and not advice to stay active.
Ibedrift is a randomized controlled trial with the aim of studying the effect of a new treatment regime for musculoskeletal pain, focusing on didactic information about low back pain with peer support. Those participants not in the control group will have the option of contacting a peer advisor, a non health professional trained by the iBedrift crew to give information about back pain and reasons to stay active. For those who have not recovered within a short period of time, and who are randomized to full treatment, the peer advisor can send them directly to health personnel for a brief intervention consisting of a medical examination with screening for conditions that need treatment, counseling and education.
The intervention was done in 2 Norwegian municipalities for all local government employees. Randomization was done at the level of working units (schools, offices etc) which allows for more message containment.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Stavern, Norway, 3294
- Spesialsykehuset for Rehabilitering
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All employees above 18 years
Exclusion Criteria:
- Cancer
- Known congenital musculoskeletal disease
- Cauda equina syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Information and peer advisor
|
Information at work place and recruitment and training of one employee as a peer advisor who help colleagues who experience musculoskeletal pain with reasons to stay active, help with adjustment in the work situation to allow individuals to stay at work.
|
|
Experimental: 2
Information, peer advisor and referral to further treatment
|
Information at work place and recruitment and training of one employee as a peer advisor who help colleagues who experience musculoskeletal pain with reasons to stay active, help with adjustment in the work situation to allow individuals to stay at work. In addition, the peer advisor can refer employees who do not improve to a two day educational program that also includes a medical exam and individual counselling. In addition, |
|
No Intervention: 3
Treatment as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sick Leave
Time Frame: 1 year and 2 year after start of intervention
|
1 year and 2 year after start of intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Low Back pain
Time Frame: 1 year and 2 years after intervention
|
1 year and 2 years after intervention
|
|
Subjective Health complaints
Time Frame: 1 year and 2 years after intervention
|
1 year and 2 years after intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Aage Indahl, Ph.d, The Hospital of Vestfold
Publications and helpful links
General Publications
- Odeen M, Ihlebaek C, Indahl A, Wormgoor ME, Lie SA, Eriksen HR. Effect of peer-based low back pain information and reassurance at the workplace on sick leave: a cluster randomized trial. J Occup Rehabil. 2013 Jun;23(2):209-19. doi: 10.1007/s10926-013-9451-z.
- Ree E, Odeen M, Eriksen HR, Indahl A, Ihlebaek C, Hetland J, Harris A. Subjective health complaints and self-rated health: are expectancies more important than socioeconomic status and workload? Int J Behav Med. 2014 Jun;21(3):411-20. doi: 10.1007/s12529-013-9329-7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
- 801622-611704
- 18997 (Other Identifier: NSD)
- S-08054b (Other Identifier: REK)
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