- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02508025
Towards Better Understanding of FCE Performance in Different Societal Contexts (FCEinternat)
22. juli 2015 opdateret af: Jan Kool, Klinik Valens
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Persons with non-specific sub-acute or chronic musculoskeletal pain
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Psychological factor: work related fear of movement (minimum 0 - maximum 10)
Tidsramme: one day (one measurement only, cross sectional study)
|
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)
Tidsramme: one day (one measurement only, cross sectional study)
|
one day (one measurement only, cross sectional study)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Work related physical capacity: max weight safely lifted from floor to waist (kg)
Tidsramme: one day (one measurement only, cross sectional study)
|
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)
Tidsramme: one day (one measurement only, cross sectional study)
|
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)
Tidsramme: one day (one measurement only, cross sectional study)
|
This measure is reliable, safe and valid as it is related to physical work capacity.
|
one day (one measurement only, cross sectional study)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2015
Primær færdiggørelse (Forventet)
1. august 2016
Studieafslutning (Forventet)
1. august 2017
Datoer for studieregistrering
Først indsendt
21. juli 2015
Først indsendt, der opfyldte QC-kriterier
22. juli 2015
Først opslået (Skøn)
24. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EKSG15/079
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .