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Completed

NCT Number: NCT02047669

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

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.

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Key information

Age range

18 year–67 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre for the Working Environment

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsychosocial

Behavioral

Reference

Behavioral

Primary outcomes

  1. Pain intensity

    Time frame: 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 outcomes

  1. Stress

    Time frame: change from baseline to week 10

    Cohens perceived stress scale

Other outcomes

  1. WAI

    Time frame: change from baseline to week 10

    Work ability index questionnaire

  2. Fear Avoidance

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

National Research Centre for the Working Environment, Denmark

Other Gov

Collaborators

  • University of Southampton
  • University of Southern Denmark

Registry information

Acronym: IRMA

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 28, 2014
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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