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

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ClinicalTrials.gov Identifier: NCT01671267
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : January 28, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment
Musculoskeletal Disorders Behavioral: Strength training Behavioral: Ergonomic

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers
Study Start Date : August 2012
Primary Completion Date : December 2012
Study Completion Date : February 2013
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).

  2. WAI [ Time Frame: change from baseline to week 10 ]
    Work ability index questionnaire

  3. 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)


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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