NCT02047682

Brief Summary

Static postures, repetitive work tasks, and work stress increase the risk for musculoskeletal disorders and sickness absence. Objective measurements of occupational loadings - EMG for muscular activity, EEG for cognitive activity, ECG for cardiovascular activity and heart rate variability, actigraphy for bodily movements - may provide useful early indicators of muscular, cognitive and cardiovascular overload. 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 these risk factors in lab technicians with a history of work-related musculoskeletal pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

January 26, 2014

Last Update Submit

September 29, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • EMG gaps

    Electromyography (EMG) is measured in the neck and shoulder muscles throughout a normal workday before and after the intervention. EMG gaps is defined as periods with muscular inactivity. Actigraphs are used to measure bodily movements, and only period with sitting or standing work are included in the analysis (i.e. walking activities are excluded from the analyses)

    change from baseline to week 10

Secondary Outcomes (2)

  • EEG

    change from baseline to week 10

  • HRV

    change from baseline til 10 week followup

Study Arms (2)

Biopsychosocial

EXPERIMENTAL

Biopsychosocial intervention with Individually tailored physical exercises and stress management

Behavioral: Biopsychosocial

Reference

ACTIVE COMPARATOR

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

Behavioral: Reference

Interventions

BiopsychosocialBEHAVIORAL
Biopsychosocial
ReferenceBEHAVIORAL
Reference

Eligibility Criteria

Age18 Years - 67 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laboratory technician
  • Pain intensity \>= 3 (scale of 0-10)
  • Pain duration \>= 3 months
  • Pain frequency \>= 3 days per week

You may not qualify if:

  • life threatening disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Centre for the Working Environment

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Models, Biopsychosocial

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative Techniques

Study Officials

  • Lars L Andersen, PhD

    National Research Centre for the Working Environment, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

January 26, 2014

First Posted

January 28, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 30, 2014

Record last verified: 2014-09

Locations