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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Musculoskeletal Disorders
• Intervention / Treatment: Behavioral: Biopsychosocial; Behavioral: Reference

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • National Research Centre for the Working Environment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	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.	change from baseline to week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress	Cohens perceived stress scale	change from baseline to week 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
WAI	Work ability index questionnaire	change from baseline to week 10
Fear Avoidance	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).	change from baseline to week 10
Muscle function	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).	change from baseline to week 10

Collaborators and Investigators

• Sponsor: National Research Centre for the Working Environment, Denmark
• Collaborators: University of Southampton; University of Southern Denmark
• Investigators: Principal Investigator: Lars L Andersen, PhD, National Research Centre for the Working Environment, Denmark

Publications and helpful links

General Publications

• Jay K, Brandt M, Hansen K, Sundstrup E, Jakobsen MD, Schraefel MC, Sjogaard G, Andersen LL. Effect of Individually Tailored Biopsychosocial Workplace Interventions on Chronic Musculoskeletal Pain and Stress Among Laboratory Technicians: Randomized Controlled Trial. Pain Physician. 2015 Sep-Oct;18(5):459-71.
• Jay K, Brandt M, Sundstrup E, Schraefel M, Jakobsen MD, Sjogaard G, Andersen LL. Effect of individually tailored biopsychosocial workplace interventions on chronic musculoskeletal pain, stress and work ability among laboratory technicians: randomized controlled trial protocol. BMC Musculoskelet Disord. 2014 Dec 18;15:444. doi: 10.1186/1471-2474-15-444.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 26, 2014
• First Submitted That Met QC Criteria: January 26, 2014
• First Posted (Estimate): January 28, 2014

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: September 1, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: IRMA09