- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06283407
ICF-based Comparison on Musculoskeletal Health in Poland and Spain
Comparative Analysis of the Musculoskeletal Health of General Population in Poland and Spain: a Cross-sectional Study Using the International Classification of Functioning, Disability and Health for Chronic Musculoskeletal Conditions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Musculoskeletal conditions are a major cause of disability worldwide. These conditions are often associated with chronicity, which is a challenge for healthcare systems to address. Health care must be person-centred and take into account the individual perspective from which the disease is experienced. The lived experience of health conditions depends to a large extent on contextual factors.
The ICF is the framework proposed by the World Health Organization to describe the organic changes caused by a condition and the modulating effect of contextual factors on the resulting disability. The ICF core sets are tools that facilitate the use of this classification in clinical practice. The ICF core sets have been developed for a wide range of health conditions, but there has traditionally been a lack of validation studies. In recent years, studies have been developed using ICF core sets for musculoskeletal conditions in different populations. In particular, the musculoskeletal health of the Polish and Spanish populations has been assessed using the brief ICF core set for post-acute musculoskeletal conditions. This availability of data allows comparisons to be made of the health status of these populations using the ICF as a frame of reference. This possibility of using ICF for this purpose is unknown in the scientific literature and could contribute to the identification of the aspects that are most relevant in the experience of the health condition.
The aim of this study is to identify differences in musculoskeletal health between the Polish and Spanish populations using the ICF as a frame of reference. The development of this study also has the aim of providing the methodological basis for the development of transnational comparisons on the basis of the ICF.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Agnieszka Wiśniowska-Szurlej, PhD
- Phone Number: + 48 604 181 162
- Email: agwisniowska@ur.edu.pl
Study Locations
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-
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Rzeszów, Poland, 35-959
- University of Rzeszow
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Contact:
- Agnieszka Wiśniowska-Szurlej
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age between 18 and 65 years,
- diagnosed musculoskeletal disorder according to ICD-10,
- normal cognitive status to perform reliable study (The Abbreviated Mental Test Score >6),
- informed and voluntary consent to participate in the study,
- sufficient knowledge of the Spanish or Polish language.
Exclusion Criteria:
- mental disorders - depression or personality disorders confirmed by a medical diagnosis,
- referral for a non-musculoskeletal problem,
- referral from hospital services.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Poland
People with musculoskeletal conditions from the general population in Poland
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ICF-based cross-country comparative analysis
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|
Spain
People with musculoskeletal conditions from the general population in Spain
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ICF-based cross-country comparative analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief International Classification of Functioning, Disability and Health (ICF) core set for post-acute musculoskeletal conditions
Time Frame: 2024-01/2024-07
|
The core set of codes cover categories, including Body Functions, Activities and Participation and Environment Factors.
All codes from each category are quantitatively assessed with qualifiers using the same scale denoting the severity of the problem or the magnitude of the impairment on a scale of 0 to 4 (xxx.0
NO problem; xxx.1 MILD problem; xxx.2 MODERATE problem; xxx.3 SEVERE problem; xxx.4 COMPLETE problem; xxx.8 not specified and xxx.9 not applicable).
|
2024-01/2024-07
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sociodemographic data of the sample (nationality, age, sex, education level, work status, number of comorbidities)
Time Frame: 2024-01/2024-07
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2024-01/2024-07
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Agnieszka Wiśniowska-Szurlej, PhD, University of Rzeszow
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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