Musculoskeletal DiseasesFCEinternatNCT02508025
Towards Better Understanding of FCE Performance in Different Societal Contexts
An observational study of Musculoskeletal Diseases, run by Klinik Valens.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Functional Capacity Evaluation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with non-specific sub-acute or chronic musculoskeletal pain
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
Jan Kool, PhD contact
Peter Oesch, PhD contact
About this study
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.
Read the 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.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Functional Capacity Evaluation
- Keywords
- disability evaluation, psychosocial factors
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Capacity EvaluationOther
Assessment of work related physical capacity
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological factor: work related fear of movement (minimum 0 - maximum 10)
The fear avoidance beliefs questionnaire has been validated for this purpose
Measured: one day (one measurement only, cross sectional study)
Financial compensation in case of work related disability (% of previous income)
Measured: one day (one measurement only, cross sectional study)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: one day (one measurement only, cross sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Kool, Klinik Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508025
- Sponsor's protocol ID
- EKSG15/079
- Acronym
- FCEinternat
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Better Understanding of FCE Performance in Different Societal Contexts
- ClinicalTrials.gov ID
- NCT02508025
- Acronym / sponsor ID
- FCEinternat / EKSG15/079
- Conditions
- Musculoskeletal Diseases
- Keywords
- disability evaluation, psychosocial factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with non-specific sub-acute or chronic musculoskeletal pain
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnancy
- Tumours
- Fractures
- Radicular syndromes
- Spondylolisthesis grade 3 or 4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Capacity EvaluationAssessment of work related physical capacity | Other | – |
Primary outcome
Psychological factor: work related fear of movement (minimum 0 - maximum 10)
Time frame: one day (one measurement only, cross sectional study)
The fear avoidance beliefs questionnaire has been validated for this purpose
Financial compensation in case of work related disability (% of previous income)
Time frame: one day (one measurement only, cross sectional study)
3 secondary outcomes
Work related physical capacity: max weight safely lifted from floor to waist (kg)
Time frame: one day (one measurement only, cross sectional study)
Work related physical capacity: distance walked in 6 minutes (meters)
Time frame: one day (one measurement only, cross sectional study)
Work related physical capacity: grip strength (kg)
Time frame: one day (one measurement only, cross sectional study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
Related trials for Musculoskeletal Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Kool, PhD contact
Peter Oesch, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases, run by Klinik Valens.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Kool, PhD (jan.kool@kliniken-valens.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological factor: work related fear of movement (minimum 0 - maximum 10) (time frame: one day (one measurement only, cross sectional study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.