Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians (IRMA)
Primary Purpose
Musculoskeletal Disorders, Stress
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Biopsychosocial
Reference
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Disorders
Eligibility Criteria
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
Sites / Locations
- National Research Centre for the Working Environment
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biopsychosocial
Reference
Arm Description
Biopsychosocial intervention with Individually tailored physical exercises and stress management
Reference group receiving "usual care" in terms of standard workplace ergonomics and physical exercises
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Stress
Cohens perceived stress scale
Full Information
NCT ID
NCT02047669
First Posted
January 26, 2014
Last Updated
September 1, 2015
Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
University of Southern Denmark, University of Southampton
1. Study Identification
Unique Protocol Identification Number
NCT02047669
Brief Title
Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
Acronym
IRMA
Official Title
Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
University of Southern Denmark, University of Southampton
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorders, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biopsychosocial
Arm Type
Experimental
Arm Description
Biopsychosocial intervention with Individually tailored physical exercises and stress management
Arm Title
Reference
Arm Type
Active Comparator
Arm Description
Reference group receiving "usual care" in terms of standard workplace ergonomics and physical exercises
Intervention Type
Behavioral
Intervention Name(s)
Biopsychosocial
Intervention Type
Behavioral
Intervention Name(s)
Reference
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
change from baseline to week 10
Secondary Outcome Measure Information:
Title
Stress
Description
Cohens perceived stress scale
Time Frame
change from baseline to week 10
Other Pre-specified Outcome Measures:
Title
WAI
Description
Work ability index questionnaire
Time Frame
change from baseline to week 10
Title
Fear Avoidance
Description
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).
Time Frame
change from baseline to week 10
Title
Muscle function
Description
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).
Time Frame
change from baseline to week 10
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars L Andersen, PhD
Organizational Affiliation
National Research Centre for the Working Environment, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Centre for the Working Environment
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
26431123
Citation
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.
Results Reference
derived
PubMed Identifier
25519844
Citation
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.
Results Reference
derived
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Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
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