Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians

Sponsor
National Research Centre for the Working Environment, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT02047669
Collaborator
University of Southern Denmark (Other), University of Southampton (Other)
112
1
2
4
27.9

Study Details

Study Description

Brief Summary

Musculoskeletal disorders and stress of employees remain a major problem in many occupations. The aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical exercises (reference group) on musculoskeletal pain, work disability, and stress in lab technicians with a history of work-related musculoskeletal pain.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Biopsychosocial
  • Behavioral: Reference
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biopsychosocial

Biopsychosocial intervention with Individually tailored physical exercises and stress management

Behavioral: Biopsychosocial

Active Comparator: Reference

Reference group receiving "usual care" in terms of standard workplace ergonomics and physical exercises

Behavioral: Reference

Outcome Measures

Primary Outcome Measures

  1. Pain intensity [change from baseline to week 10]

    The change in "pain intensity during the last week" (average value of back, neck, shoulder, elbow and hand) from baseline to 10 week follow-up between the individually tailored biopsychosocial group and reference group. 2-way analysis of variance with repeated measures will be used, with time, group and time x group as fixed factors and subject as random factor. Analyses will be controlled for pain intensity at baseline.

Secondary Outcome Measures

  1. Stress [change from baseline to week 10]

    Cohens perceived stress scale

Other Outcome Measures

  1. WAI [change from baseline to week 10]

    Work ability index questionnaire

  2. Fear Avoidance [change from baseline to week 10]

    Fear avoidance is evaluated by the Fear Avoidance Beliefs questionnaire (FABQ) by Waddell et al. at baseline and follow-up. Briefly, the FABQ is a two-part questionnaire. The first part consists of five questions/statements about pain and physical activity and the second part consists of 11 questions/statements about how work affects the participants' perception of pain. Each question is scored from 0-5 ranging from completely disagree (0) to completely agree (5).

  3. Muscle function [change from baseline to week 10]

    Muscle strength, function and tenderness of the shoulder, arm, wrist/hand is assessed by maximal isometric voluntary contractions in a custom-built dynamometer (Bofors Elektronik, Karlskoga, Sweden) setting and by pressure-pain threshold testing (PPT). Also rate of force development (RFD), force steadiness (FS), force precision (FP) and fatigue (F) are measured by using custom-made MATLAB programs. The strength tests are a part of an extensive physical examination by trained (and blinded) medical professionals at baseline and follow-up. Muscle activation level is measured by surface electromyography (EMG) (Nexus Mark 10, Mindmedia, Netherlands) on the forearm extensors, shoulder external rotator (Infraspinatus Mm.) and descending part of the trapezius muscle. Further, surface EEG (Nexus Mark 10, Mindmedia, Netherlands) will measure global brain activity during pre- and post testing by using a single a single sensor placement on the forehead (Fpz).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 67 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Laboratory technician

  • Pain intensity >= 3 (scale of 0-10)

  • Pain duration >= 3 months

  • Pain frequency >= 3 days per week

Exclusion Criteria:
  • life threatening disease

  • pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Research Centre for the Working Environment Copenhagen Denmark 2100

Sponsors and Collaborators

  • National Research Centre for the Working Environment, Denmark
  • University of Southern Denmark
  • University of Southampton

Investigators

  • Principal Investigator: Lars L Andersen, PhD, National Research Centre for the Working Environment, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lars L. Andersen, Professor, PhD, National Research Centre for the Working Environment, Denmark
ClinicalTrials.gov Identifier:
NCT02047669
Other Study ID Numbers:
  • IRMA09
First Posted:
Jan 28, 2014
Last Update Posted:
Sep 2, 2015
Last Verified:
Sep 1, 2015
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2015