NCT02508025

Brief Summary

Purposes of this research:

  • To study similarities and differences in FCE performances between participants from different countries, jurisdictions, and evaluators.
  • To study determinants of FCE performance.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Status
unknown

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

July 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

July 21, 2015

Last Update Submit

July 22, 2015

Conditions

Keywords

disability evaluationpsychosocial factors

Outcome Measures

Primary Outcomes (2)

  • Psychological factor: work related fear of movement (minimum 0 - maximum 10)

    The fear avoidance beliefs questionnaire has been validated for this purpose

    one day (one measurement only, cross sectional study)

  • Financial compensation in case of work related disability (% of previous income)

    one day (one measurement only, cross sectional study)

Secondary Outcomes (3)

  • Work related physical capacity: max weight safely lifted from floor to waist (kg)

    one day (one measurement only, cross sectional study)

  • Work related physical capacity: distance walked in 6 minutes (meters)

    one day (one measurement only, cross sectional study)

  • Work related physical capacity: grip strength (kg)

    one day (one measurement only, cross sectional study)

Interventions

Assessment of work related physical capacity

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Persons with non-specific sub-acute or chronic musculoskeletal pain

You may qualify if:

  • Musculoskeletal pain including: back pain, neck pain (including Whiplash-Associated Syndrome grade I or II), upper extremity pain, lower extremity pain.

You may not qualify if:

  • Complaints' duration \> 6 weeks
  • Employed or self-employed
  • Language skills sufficient to communicate with the FCE-clinician and fill out the required questionnaires
  • Pregnancy
  • Tumours
  • Fractures
  • Radicular syndromes
  • Spondylolisthesis grade 3 or 4)
  • Whiplash-Associated Syndrome grade III or IV
  • Other specific diagnoses related to the musculoskeletal System
  • Unstable cardiovascular conditions and other co-morbidity affecting performance or safety during the FCE (i.e. severe depression needing psychiatric referral).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Jan Kool, PhD

CONTACT

Peter Oesch, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 24, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

July 24, 2015

Record last verified: 2015-07