Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers

Musculoskeletal Disorders Clinical Trial

— IRMA  

Official title:

Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671267
• Other study ID #: IRMA06
• Status: Completed
• Phase: N/A
• First received: August 20, 2012
• Last updated: January 26, 2014
• Start date: August 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: National Research Centre for the Working Environment, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers, allegedly due to the substantial load of these body regions during work. Work disability is a common consequence of these pains. Lowering the physical exposure through ergonomic intervention may be a strategy to reduce the workload. An alternative strategy could be to increase the physical capacity through strength training of the shoulder-, arm- and hand-muscles. This study investigates the effect of two contrasting interventions, i.e. load reduction (ergonomic intervention) versus training of physical capacity (strength training) on pain and work disability in slaughterhouse workers.

The main hypothesis is that strength training intervention for 10 weeks compared with ergonomic intervention results in reduced pain of the shoulder, arm and hand.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

• Slaughterhouse worker

• the pain should have lasted at least 3 months

• pain intensity during the last three months of >= 3 (scale 0-10) in the shoulder, elbow or hand

• the pain should be frequent (at least 3 days per week)

Exclusion Criteria:

• life threatening disease

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Musculoskeletal Disorders

Intervention

Behavioral:
• Strength training

• Ergonomic

Locations

Country	Name	City	State
Denmark	National Research Centre for the Working Environment	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
National Research Centre for the Working Environment, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PPT	Pressure pain threshold of the muscle of the forearm, external rotators of the shoulder, and tibialis anterior of the leg (reference muscle).	change from baseline to week 10	No
Other	WAI	Work ability index questionnaire	change from baseline to week 10	No
Other	Total tenderness score	change in examiner-verified tenderness of the muscles of the shoulder, arm and hand. Scale of "no", "a little", "moderate" and "severe" tenderness. Summed up to a total tenderness score (Andersen LL 2011, PMID: 21177034)	change from baseline to week 10	No
Primary	Pain intensity	The change in "pain intensity during the last week" (average value of shoulder, elbow and hand) from baseline to 10 week follow-up between the strength training group and ergonomic group. The ergonomic group will be considered the reference group. 2-way analysis of variance (Proc Mixed of SAS) with repeated measures will be used, with time and group as fixed factors and subject as random factor.	change from baseline to week 10	No
Secondary	DASH	Disability of the arm, shoulder and hand questionnaire (DASH). Only the work-module of DASH will be included. Analyzed the same way as the primary outcome.	change from baseline to week 10	No