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

January 26, 2014 updated by: Lars L. Andersen, National Research Centre for the Working Environment, Denmark

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 2100
        • National Research Centre for the Working Environment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strength training
Strength training of the shoulder, arm and hand muscles for 3 x 10 minutes a week.
Active Comparator: Ergonomic
Receives counseling on workstation adjustment and optimal use of the work tools.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: change from baseline to week 10
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH
Time Frame: change from baseline to week 10
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPT
Time Frame: change from baseline to week 10
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
WAI
Time Frame: change from baseline to week 10
Work ability index questionnaire
change from baseline to week 10
Total tenderness score
Time Frame: change from baseline to week 10
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lars L Andersen, PhD, National Research Centre for the Working Environment, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

August 20, 2012

First Submitted That Met QC Criteria

August 20, 2012

First Posted (Estimate)

August 23, 2012

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 26, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRMA06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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