Towards Better Understanding of FCE Performance in Different Societal Contexts

NCT ID: NCT02508025

Last Updated: 2015-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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A considerable amount of research has been made on the safety, reliability and validity of the Functional Capacity Evaluation (FCE). Evidence is accumulating on different aspects of validity of FCE in healthy workers and in different patient groups, which has indicated that we are measuring a complex construct consisting of biological, psychological and social variables. However, this knowledge is still unstable as the majority of studies stem from a limited amount of countries. The present project focuses on the biopsychosocial factors that influence FCE performance. Participants undergoing an FCE perform differently depending on biological, psychological and social variables, although the latter has been under-researched. Clinicians are currently unable to predict which factors determine the differences in patient's FCE results. In this project, in addition to biological and psychological variables, investigators include a variety of social variables from different countries, jurisdictions, and evaluators, which may help investigators to identify important determinants of FCE performance. Knowing which characteristics and behaviors are associated with better or poorer participant performances may help clinicians to deliver improved FCE services.

Conditions

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Musculoskeletal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Functional Capacity Evaluation

Assessment of work related physical capacity

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinik Valens

OTHER

Sponsor Role lead

Responsible Party

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Jan Kool

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jan Kool, PhD

Role: CONTACT

Peter Oesch, PhD

Role: CONTACT

Other Identifiers

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EKSG15/079

Identifier Type: -

Identifier Source: org_study_id

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