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Towards better understanding of FCE performance in different societal contexts


- candidate number22882
- NTR NumberNTR5494
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-sep-2015
- Secondary IDsMETc 2015-233 
- Public TitleTowards better understanding of FCE performance in different societal contexts
- Scientific TitleTowards better understanding of FCE performance in different societal contexts
- ACRONYM
- hypothesisDifferences in the healthcare, workplace, legislative, and personal systems (see figure) as well as evaluator and patient characteristics may better explain differences in FCE results
- Healt Condition(s) or Problem(s) studiedMuscoskeletal complaints
- Inclusion criteriaPatients:
- Aged between 18 and 65 years old
- Diagnosed with non-specific sub-acute or chronic pain
- Undergo FCE as part of routine clinical care/evaluation
Clinicians:
- Trained to perform a standardized FCE
- More than 1 year of experience and more than 20 FCEs performed on the target group
- Sufficient understanding of the English language
- Exclusion criteriaPatients:
- Pregnant, retired or on permanent sick-leave
- Presenting specific diagnoses related to the musculoskeletal system, and/or with relevant medical co-morbidity such as unstable cardiovascular conditions
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-feb-2015
- planned closingdate30-jun-2016
- Target number of participants500
- InterventionsThe study is designed as ‘care as usual’ for the patients, and as close as possible to care as usual for clinicians. FCE will be performed according to regular protocols, with a mandatory core set of tests: low lifting (all patients), and walking or handgrip strength (clinician’s decision depending on the affected region or work demands). Other tests can be performed for FCE, but data will not be collected for this study.
- Primary outcomeFCE results:
- Floor to waist lifting (kg)
- Six minute walking test (meters)
- Grip strength (kg)
- Secondary outcome- Patient characteristics: age, gender, BMI (height, weight), country, mother language, educational level, employment characteristics, employment status (currently working and availability of modified duties), diagnosis, compensation status, and self-rated pain intensity, factors associated with pain, work ability, disability.
- Clinician characteristics: age, gender, profession, years of experience as clinician and performing FCE, number of FCEs performed in the last 2 years, pain beliefs.
- System characteristics: country, legislation, insurance characteristics.
- FCE characteristics: type of protocol used, tests performed, purpose of the FCE (i.e. return-to-work testing, pre-rehabilitation), FCE related variables: self-perceived exertion (Borg CR-10 scale), observational criteria for determination of physical effort (during low lifting test).
- TimepointsSeptember 2015 - March 2016: study conduct, including data entry.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Ansuategui Echeita
- CONTACT for SCIENTIFIC QUERIES J. Ansuategui Echeita
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN/A
- Brief summaryA considerable amount of research has been conducted on Functional Capacity Evaluation (FCE) performance. Evidence is accumulating on a bio-psycho-social model influence; differences in age, gender, self-efficacy, motivation, country, and mother language have been found associated with FCE performance. Previous research has focused on biological and psychological factors; however, studies on social factor’s influence are lacking. The present project aims to provide better understanding of the societal variables that affect FCE results.
This is a cross-sectional study, developed as close as possible to ‘care as usual’. Patients enrolled will be between 18 and 65 years of age, diagnosed with non-specific sub-acute or chronic pain, and undergo FCE as part of routine clinical care. Bio-psycho-social data and FCE characteristics will be collected from different countries, institutions and evaluators. Patients are asked to fill a short questionnaire about pain intensity, factors associated with pain, work ability, and disability. Clinicians are asked to complete two data collection forms: one with patient and FCE characteristics; and another one with information about themselves, including an adapted Back Beliefs Questionnaire. A core set of lifting, and walking or handgrip strength test will be measured.
Collected data will be de-identified. It will be sent periodically to country liaisons who will de-identify patients and clinicians, merge data, and send to the principal investigator. The data collection phase will last 6 months. Country liaisons are in charge of adapting the protocol to their country guidelines and regulations, and coordinating data collection.
- Main changes (audit trail)
- RECORD16-sep-2015 - 5-jan-2016


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