NCT00741650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,097

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

3.1 years

First QC Date

August 25, 2008

Last Update Submit

February 25, 2015

Conditions

Neck Pain MusculoskeletalBack Pain Lower Back

Keywords

Musculoskeletal painBrief cognitive interventionCognitive behavior therapyIntervention StudyHealth preventionworkplace intervention

Outcome Measures

Primary Outcomes (1)

  • Sick Leave

    1 year and 2 year after start of intervention

Secondary Outcomes (2)

  • Low Back pain

    1 year and 2 years after intervention

  • Subjective Health complaints

    1 year and 2 years after intervention

Study Arms (3)

1

EXPERIMENTAL

Information and peer advisor

Behavioral: Information and Peer advisor

2

EXPERIMENTAL

Information, peer advisor and referral to further treatment

Behavioral: Information, peer advisor and fast referral

3

NO INTERVENTION

Treatment as usual

Interventions

Information and Peer advisorBEHAVIORAL

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.

1
Information, peer advisor and fast referralBEHAVIORAL

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,

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All employees above 18 years

You may not qualify if:

  • Cancer
  • Known congenital musculoskeletal disease
  • Cauda equina syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spesialsykehuset for Rehabilitering

Stavern, 3294, Norway

Location

Related Publications (2)

  • 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.

    PMID: 23657490BACKGROUND

  • 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.

    PMID: 23868103BACKGROUND

MeSH Terms

Conditions

Low Back PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Aage Indahl, Ph.d

    The Hospital of Vestfold

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 26, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2011

Study Completion

December 1, 2012

Last Updated

February 26, 2015

Record last verified: 2015-02

Locations

NO(1)