NCT01671267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

August 20, 2012

Last Update Submit

January 26, 2014

Conditions

Musculoskeletal Disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    change from baseline to week 10

Secondary Outcomes (1)

  • DASH

    change from baseline to week 10

Other Outcomes (3)

  • PPT

    change from baseline to week 10

  • WAI

    change from baseline to week 10

  • Total tenderness score

    change from baseline to week 10

Study Arms (2)

Strength training

EXPERIMENTAL

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

Behavioral: Strength training

Ergonomic

ACTIVE COMPARATOR

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

Behavioral: Ergonomic

Interventions

Strength trainingBEHAVIORAL
Strength training
ErgonomicBEHAVIORAL
Ergonomic

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • life threatening disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Centre for the Working Environment

Copenhagen, 2100, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 27830144DERIVED

  • 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.

    PMID: 24658475DERIVED

  • 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.

    PMID: 23433448DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Resistance TrainingErgonomics

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEngineeringTechnology, Industry, and Agriculture

Study Officials

  • Lars L Andersen, PhD

    National Research Centre for the Working Environment, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 23, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

DK(1)