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

Primary Purpose

Musculoskeletal Disorders

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Strength training
Ergonomic
Sponsored by
National Research Centre for the Working Environment, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Disorders

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Research Centre for the Working Environment

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strength training

Ergonomic

Arm Description

Strength training of the shoulder, arm and hand muscles for 3 x 10 minutes a week.

Receives counseling on workstation adjustment and optimal use of the work tools.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 20, 2012
Last Updated
January 26, 2014
Sponsor
National Research Centre for the Working Environment, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01671267
Brief Title
Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers
Acronym
IRMA
Official Title
Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre for the Working Environment, Denmark

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength training
Arm Type
Experimental
Arm Description
Strength training of the shoulder, arm and hand muscles for 3 x 10 minutes a week.
Arm Title
Ergonomic
Arm Type
Active Comparator
Arm Description
Receives counseling on workstation adjustment and optimal use of the work tools.
Intervention Type
Behavioral
Intervention Name(s)
Strength training
Intervention Type
Behavioral
Intervention Name(s)
Ergonomic
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
change from baseline to week 10
Secondary Outcome Measure Information:
Title
DASH
Description
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.
Time Frame
change from baseline to week 10
Other Pre-specified Outcome Measures:
Title
PPT
Description
Pressure pain threshold of the muscle of the forearm, external rotators of the shoulder, and tibialis anterior of the leg (reference muscle).
Time Frame
change from baseline to week 10
Title
WAI
Description
Work ability index questionnaire
Time Frame
change from baseline to week 10
Title
Total tenderness score
Description
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)
Time Frame
change from baseline to week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars L Andersen, PhD
Organizational Affiliation
National Research Centre for the Working Environment, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Centre for the Working Environment
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27830144
Citation
Sundstrup E, Jakobsen MD, Brandt M, Jay K, Aagaard P, Andersen LL. Strength Training Improves Fatigue Resistance and Self-Rated Health in Workers with Chronic Pain: A Randomized Controlled Trial. Biomed Res Int. 2016;2016:4137918. doi: 10.1155/2016/4137918. Epub 2016 Oct 17.
Results Reference
derived
PubMed Identifier
24658475
Citation
Sundstrup E, Jakobsen MD, Andersen CH, Jay K, Persson R, Aagaard P, Andersen LL. Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial. Pain Physician. 2014 Mar-Apr;17(2):145-54. Erratum In: Pain Physician. 2014 May-Jun;17(3):E275.
Results Reference
derived
PubMed Identifier
23433448
Citation
Sundstrup E, Jakobsen MD, Andersen CH, Jay K, Persson R, Aagaard P, Andersen LL. Participatory ergonomic intervention versus strength training on chronic pain and work disability in slaughterhouse workers: study protocol for a single-blind, randomized controlled trial. BMC Musculoskelet Disord. 2013 Feb 21;14:67. doi: 10.1186/1471-2474-14-67.
Results Reference
derived

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

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