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

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.

Study Overview

• Status: Unknown
• Conditions: Musculoskeletal Diseases
• Intervention / Treatment: Other: Functional Capacity Evaluation

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work related physical capacity: max weight safely lifted from floor to waist (kg)	This measure is reliable, safe and valid as it is related to physical work capacity.	one day (one measurement only, cross sectional study)
Work related physical capacity: distance walked in 6 minutes (meters)	This measure is reliable, safe and valid as it is related to physical work capacity.	one day (one measurement only, cross sectional study)
Work related physical capacity: grip strength (kg)	This measure is reliable, safe and valid as it is related to physical work capacity.	one day (one measurement only, cross sectional study)

Collaborators and Investigators

• Sponsor: Klinik Valens

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Estimate): July 24, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: disability evaluation; psychosocial factors
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: EKSG15/079