Ibedrift- A Trial Comparing a New Approach to Musculoskeletal Pain Consisting of Education and Peer Involvement to Treatment as Usual

Neck Pain Musculoskeletal Clinical Trial

— Ibedrift  

Official title:

Ibedrift- Health Related Coping. A Randomized Controlled Trial Comparing a Worksite Educational Intervention With or Without Referral to Treatment as Usual.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741650
• Other study ID #: 801622-611704
• Secondary ID: 18997S-08054b
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 25, 2008
• Last updated: February 25, 2015
• Start date: September 2008
• Est. completion date: December 2012

Study information

• Verified date: February 2015
• Source: Uni Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2097
• Est. completion date: December 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All employees above 18 years

Exclusion Criteria:

• Cancer

• Known congenital musculoskeletal disease

• Cauda equina syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain Lower Back
• Musculoskeletal Pain
• Neck Pain Musculoskeletal

Intervention

Behavioral:
• 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.
• Information, peer advisor and fast referral
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,

Locations

Country	Name	City	State
Norway	Spesialsykehuset for Rehabilitering	Stavern

Sponsors (3)

Lead Sponsor	Collaborator
Uni Research	Helse Sor-Ost, Sykehuset i Vestfold HF

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Odeen M, Ihlebæk 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. — View Citation

Ree E, Odeen M, Eriksen HR, Indahl A, Ihlebæk 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sick Leave		1 year and 2 year after start of intervention	No
Secondary	Low Back pain		1 year and 2 years after intervention	No
Secondary	Subjective Health complaints		1 year and 2 years after intervention	No