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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sykehuset i Vestfold HF
Helse Sor-Ost
Information provided by (Responsible Party):
Uni Research
ClinicalTrials.gov Identifier:
NCT00741650
First received: August 25, 2008
Last updated: January 10, 2012
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Neck Pain Musculoskeletal
Back Pain Lower Back
 Behavioral: Information and Peer advisor
Behavioral: Information, peer advisor and fast referral
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ibedrift- Health Related Coping. A Randomized Controlled Trial Comparing a Worksite Educational Intervention With or Without Referral to Treatment as Usual.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uni Research:

Primary Outcome Measures:
  • Sick Leave [ Time Frame: 1 year and 2 year after start of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Low Back pain [ Time Frame: 1 year and 2 years after intervention ] [ Designated as safety issue: No ]
  • Subjective Health complaints [ Time Frame: 1 year and 2 years after intervention ] [ Designated as safety issue: No ]

Enrollment: 2097
Study Start Date: September 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Information and peer advisor
 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.
Experimental: 2
Information, peer advisor and referral to further treatment
 Behavioral: 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,
No Intervention: 3
Treatment as usual

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All employees above 18 years

Exclusion Criteria:

  • Cancer
  • Known congenital musculoskeletal disease
  • Cauda equina syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741650

Locations
Norway
Spesialsykehuset for Rehabilitering
Stavern, Norway, 3294
Sponsors and Collaborators
Uni Research
Sykehuset i Vestfold HF
Helse Sor-Ost
Investigators
Principal Investigator: Aage Indahl, Ph.d The Hospital of Vestfold
  More Information

No publications provided

Responsible Party: Uni Research
ClinicalTrials.gov Identifier: NCT00741650     History of Changes
Other Study ID Numbers: 801622-611704, 18997, S-08054b
Study First Received: August 25, 2008
Last Updated: January 10, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Uni Research:
Musculoskeletal pain
Brief cognitive intervention
Cognitive behavior therapy
 Intervention Study
Health prevention
workplace intervention

Additional relevant MeSH terms:
Back Pain
Neck Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013