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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lars L. Andersen, National Research Centre for the Working Environment, Denmark
ClinicalTrials.gov Identifier:
NCT01671267
First received: August 20, 2012
Last updated: January 26, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Musculoskeletal Disorders
Behavioral: Strength training
Behavioral: Ergonomic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers

Resource links provided by NLM:


Further study details as provided by National Research Centre for the Working Environment, Denmark:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: change from baseline to week 10 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • DASH [ Time Frame: change from baseline to week 10 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • PPT [ Time Frame: change from baseline to week 10 ] [ Designated as safety issue: No ]
    Pressure pain threshold of the muscle of the forearm, external rotators of the shoulder, and tibialis anterior of the leg (reference muscle).

  • WAI [ Time Frame: change from baseline to week 10 ] [ Designated as safety issue: No ]
    Work ability index questionnaire

  • Total tenderness score [ Time Frame: change from baseline to week 10 ] [ Designated as safety issue: No ]
    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)


Enrollment: 66
Study Start Date: August 2012
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strength training
Strength training of the shoulder, arm and hand muscles for 3 x 10 minutes a week.
Behavioral: Strength training
Active Comparator: Ergonomic
Receives counseling on workstation adjustment and optimal use of the work tools.
Behavioral: Ergonomic

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671267

Locations
Denmark
National Research Centre for the Working Environment
Copenhagen, Denmark, 2100
Sponsors and Collaborators
National Research Centre for the Working Environment, Denmark
Investigators
Principal Investigator: Lars L Andersen, PhD National Research Centre for the Working Environment, Denmark
  More Information

No publications provided by National Research Centre for the Working Environment, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lars L. Andersen, Professor, PhD, National Research Centre for the Working Environment, Denmark
ClinicalTrials.gov Identifier: NCT01671267     History of Changes
Other Study ID Numbers: IRMA06
Study First Received: August 20, 2012
Last Updated: January 26, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014