- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01671267
Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers (IRMA)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- National Research Centre for the Working Environment
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Lars L Andersen, PhD, National Research Centre for the Working Environment, Denmark
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Musculoskeletal Disorders
-
Al-Baha UniversityNot yet recruitingMusculoskeletal Disorders | Work-Related Musculoskeletal Disorders | Occupational Musculoskeletal Disorders
-
Fondazione Policlinico Universitario Campus Bio-MedicoRecruiting
-
Aalborg UniversityDagrofa Logistics A/SCompletedWork-related Musculoskeletal DisordersDenmark
-
Eastern Washington UniversityUniversity of Oregon; Oregon State University; St. Luke's Rehabilitation InstituteUnknownWork Related Musculoskeletal DisordersUnited States
-
Imam Abdulrahman Bin Faisal UniversityCompletedWork Related Musculoskeletal DisordersSaudi Arabia
-
Singapore General HospitalSengkang General Hospital; Servo DynamicsCompletedWork-related Musculoskeletal DisordersSingapore
-
Vanderbilt UniversityCompletedScapular and Cervical Neuromuscular Control Deficits in Musicians With and Without Playing Injuries.Playing Related Musculoskeletal DisordersUnited States
-
Sheba Medical CenterUnknownWork Related Musculoskeletal DisordersIsrael
-
ErgosolCompletedDescribe Musculoskeletal Disorders of WorkersArgentina
-
Assistance Publique - Hôpitaux de ParisCompletedBack Musculoskeletal DisordersFrance
Clinical Trials on Strength training
-
University of FloridaCompleted
-
University of AarhusUnknownOsteoarthritis, KneeDenmark
-
Universidad Autónoma de Manizales, ColombiaCompletedFemale | Volleyball | PlayerColombia
-
Norwegian University of Science and TechnologyCompleted
-
Lislei Jorge PatrizziCompleted
-
Eunice Kennedy Shriver National Institute of Child...Shriners Hospitals for Children; University of DelawareUnknownSpastic Diplegic Cerebral PalsyUnited States
-
University of VigoNot yet recruitingPatients | Cancer Survivors | NeoplamsSpain
-
Christian DallCompletedHeart Failure | Ischemic Heart Disease | Heart Transplant RecipientsDenmark
-
Isra UniversityCompleted
-
Cardenal Herrera UniversityNot yet recruiting