Towards Better Understanding of FCE Performance in Different Societal Contexts

Musculoskeletal Diseases Clinical Trial

— FCEinternat  

Official title:

Towards Better Understanding of FCE Performance in Different Societal Contexts

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02508025
• Other study ID #: EKSG15/079
• Status: Not yet recruiting
• Phase: N/A
• First received: July 21, 2015
• Last updated: July 22, 2015
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: July 2015
• Source: Klinik Valens
• Contact: Jan Kool, PhD
• Email: jan.kool[@]kliniken-valens.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Intervention

Other:
• Functional Capacity Evaluation
Assessment of work related physical capacity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Klinik Valens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Financial compensation in case of work related disability (% of previous income)		one day (one measurement only, cross sectional study)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No