Ibedrift- A Trial Comparing a New Approach to Musculoskeletal Pain Consisting of Education and Peer Involvement to Treatment as Usual (Ibedrift)
Primary Purpose
Neck Pain Musculoskeletal, Back Pain Lower Back
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Information and Peer advisor
Information, peer advisor and fast referral
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain Musculoskeletal focused on measuring Musculoskeletal pain, Brief cognitive intervention, Cognitive behavior therapy, Intervention Study, Health prevention, workplace intervention
Eligibility Criteria
Inclusion Criteria:
- All employees above 18 years
Exclusion Criteria:
- Cancer
- Known congenital musculoskeletal disease
- Cauda equina syndrome
Sites / Locations
- Spesialsykehuset for Rehabilitering
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
1
2
3
Arm Description
Information and peer advisor
Information, peer advisor and referral to further treatment
Treatment as usual
Outcomes
Primary Outcome Measures
Sick Leave
Secondary Outcome Measures
Low Back pain
Subjective Health complaints
Full Information
NCT ID
NCT00741650
First Posted
August 25, 2008
Last Updated
February 25, 2015
Sponsor
NORCE Norwegian Research Centre AS
Collaborators
Sykehuset i Vestfold HF, Helse Sor-Ost
1. Study Identification
Unique Protocol Identification Number
NCT00741650
Brief Title
Ibedrift- A Trial Comparing a New Approach to Musculoskeletal Pain Consisting of Education and Peer Involvement to Treatment as Usual
Acronym
Ibedrift
Official Title
Ibedrift- Health Related Coping. A Randomized Controlled Trial Comparing a Worksite Educational Intervention With or Without Referral to Treatment as Usual.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS
Collaborators
Sykehuset i Vestfold HF, Helse Sor-Ost
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized controlled trial comparing a new approach to musculoskeletal pain consisting of education and peer involvement to treatment as usual. All local government employees in 1-3 Norwegian municipalities will be invited to participate.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain Musculoskeletal, Back Pain Lower Back
Keywords
Musculoskeletal pain, Brief cognitive intervention, Cognitive behavior therapy, Intervention Study, Health prevention, workplace intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2097 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Information and peer advisor
Arm Title
2
Arm Type
Experimental
Arm Description
Information, peer advisor and referral to further treatment
Arm Title
3
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Information and Peer advisor
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Information, peer advisor and fast referral
Intervention Description
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,
Primary Outcome Measure Information:
Title
Sick Leave
Time Frame
1 year and 2 year after start of intervention
Secondary Outcome Measure Information:
Title
Low Back pain
Time Frame
1 year and 2 years after intervention
Title
Subjective Health complaints
Time Frame
1 year and 2 years after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All employees above 18 years
Exclusion Criteria:
Cancer
Known congenital musculoskeletal disease
Cauda equina syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aage Indahl, Ph.d
Organizational Affiliation
The Hospital of Vestfold
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spesialsykehuset for Rehabilitering
City
Stavern
ZIP/Postal Code
3294
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
23657490
Citation
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.
Results Reference
background
PubMed Identifier
23868103
Citation
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.
Results Reference
background
Learn more about this trial
Ibedrift- A Trial Comparing a New Approach to Musculoskeletal Pain Consisting of Education and Peer Involvement to Treatment as Usual
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