NCT02047669

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

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
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4 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 2, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

January 26, 2014

Last Update Submit

September 1, 2015

Conditions

Musculoskeletal DisordersStress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Stress

    change from baseline to week 10

Other Outcomes (3)

  • WAI

    change from baseline to week 10

  • Fear Avoidance

    change from baseline to week 10

  • Muscle function

    change from baseline to week 10

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

Related Publications (2)

  • 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.

    PMID: 26431123DERIVED

  • 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.

    PMID: 25519844DERIVED

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
TREATMENT
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

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 2, 2015

Record last verified: 2015-09

Locations

DK(1)