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Towards Better Understanding of FCE Performance in Different Societal Contexts (FCEinternat)

K

Klinik Valens

Status

Unknown

Conditions

Musculoskeletal Diseases

Treatments

Other: Functional Capacity Evaluation

Study type

Observational

Funder types

Other

Identifiers

NCT02508025
EKSG15/079

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Musculoskeletal pain including: back pain, neck pain (including Whiplash-Associated Syndrome grade I or II), upper extremity pain, lower extremity pain.
  • Non-specific pain: without specific medical diagnosis, see also 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

Exclusion criteria

  • 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).

Trial contacts and locations

0

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Central trial contact

Jan Kool, PhD; Peter Oesch, PhD

Data sourced from clinicaltrials.gov

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