Clinical trial NCT02508025: Towards Better Understanding of FCE Performance in Different Societal Contexts
Official title: Towards Better Understanding of FCE Performance in Different Societal Contexts
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Diseases
Keywords: disability evaluation
psychosocial factors
Lead sponsor: Klinik Valens
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with non-specific sub-acute or chronic musculoskeletal pain

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Psychological factor: work related fear of movement (minimum 0 - maximum 10)
timeFrame: one day (one measurement only, cross sectional study)
measure: Financial compensation in case of work related disability (% of previous income)
timeFrame: one day (one measurement only, cross sectional study)
Secondary outcomes:
measure: Work related physical capacity: max weight safely lifted from floor to waist (kg)
timeFrame: one day (one measurement only, cross sectional study)
measure: Work related physical capacity: distance walked in 6 minutes (meters)
timeFrame: one day (one measurement only, cross sectional study)
measure: Work related physical capacity: grip strength (kg)
timeFrame: one day (one measurement only, cross sectional study)
Other outcomes:
Locations:
Study officials:
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