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

Stress Clinical Trial

— IRMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047669
• Other study ID #: IRMA09
• Status: Completed
• Phase: N/A
• First received: January 26, 2014
• Last updated: September 1, 2015
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: September 2015
• Source: National Research Centre for the Working Environment, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 67 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Musculoskeletal Disorders
• Stress

Intervention

Behavioral:
• Biopsychosocial

• Reference

Locations

Country	Name	City	State
Denmark	National Research Centre for the Working Environment	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
National Research Centre for the Working Environment, Denmark	University of Southampton, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	WAI	Work ability index questionnaire	change from baseline to week 10	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	Stress	Cohens perceived stress scale	change from baseline to week 10	No