Musculoskeletal Diseases or ConditionsNCT06283407
ICF-based Comparison on Musculoskeletal Health in Poland and Spain
An observational study of Musculoskeletal Diseases or Conditions, run by University of Rzeszow at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Diseases or Conditions
- What is being tested?
- ICF-based cross-country comparative analysis
- How many people
- 800 participants
- Where
- 1 sitePoland
- Study dates
- 4 Mar 2024to 4 Nov 2024
- 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: People with musculoskeletal conditions from the general population in Poland and Spain will be the potential participants in this study.
Who may be able to join
- 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.
Who cannot join
- mental disorders - depression or personality disorders confirmed by a medical diagnosis,
- referral for a non-musculoskeletal problem,
- referral from hospital services.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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. Comparison between different contexts helps to identify which aspects are most relevant in the experience of the disease. The International Classification of Functioning, Disability and Health (ICF) provides a unified language that allows such comparisons to be made. 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.
Read the 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.
- Conditions
- Musculoskeletal Diseases or Conditions
- Being tested
- ICF-based cross-country comparative analysis
- Keywords
- International Classification of Functioning, Disability and Health; Musculoskeletal Diseases;, Disability Evaluation, Musculoskeletal Diseases
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICF-based cross-country comparative analysisOther
ICF-based cross-country comparative analysis
| Study group | Role | What they receive |
|---|---|---|
| Poland | People with musculoskeletal conditions from the general population in Poland Receives: Other: ICF-based cross-country comparative analysis | |
| Spain | People with musculoskeletal conditions from the general population in Spain Receives: Other: ICF-based cross-country comparative analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief International Classification of Functioning, Disability and Health (ICF) core set for post-acute musculoskeletal conditions
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).
Measured: 2024-01/2024-07
Secondary outcomes (1)
Sociodemographic data of the sample (nationality, age, sex, education level, work status, number of comorbidities)
Measured: 2024-01/2024-07
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start4 Mar 2024 (estimated)
- Primary completion3 Jun 2024 (estimated)
- Study completion4 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal Diseases or ConditionsStudies 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
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Collaborators
- Sanidad de Castilla y León
- Responsible party
- Principal investigator, Agnieszka Wiśniowska-Szurlej, University of Rzeszow
- Investigators
- Agnieszka Wiśniowska-Szurlej, PhD, Principal investigator, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283407
- Sponsor's protocol ID
- ICF
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wisniowska-Szurlej A, Sozanska A, Barrio SJ, Sozanski B, Ceballos-Laita L, Hernandez-Lazaro H. ICF based comparison of musculoskeletal health in regions of Poland and Spain. Sci Rep. 2024 Nov 12;14(1):27671. doi: 10.1038/s41598-024-77450-2.
PubMed 39532934
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06283407
- Acronym / sponsor ID
- ICF
- Conditions
- Musculoskeletal Diseases or Conditions
- Keywords
- International Classification of Functioning, Disability and Health; Musculoskeletal Diseases;, Disability Evaluation, Musculoskeletal Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Collaborators
- Sanidad de Castilla y León
- Study start
- 4 Mar 2024 (estimated)
- Primary completion
- 3 Jun 2024 (estimated)
- Study completion
- 4 Nov 2024 (estimated)
- First posted
- 28 Feb 2024 (actual)
- 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.
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. Comparison between different contexts helps to identify which aspects are most relevant in the experience of the disease. The International Classification of Functioning, Disability and Health (ICF) provides a unified language that allows such comparisons to be made. 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poland | – | Other: ICF-based cross-country comparative analysisPeople with musculoskeletal conditions from the general population in Poland |
| Spain | – | Other: ICF-based cross-country comparative analysisPeople with musculoskeletal conditions from the general population in Spain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with musculoskeletal conditions from the general population in Poland and Spain will be the potential participants in this study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- mental disorders - depression or personality disorders confirmed by a medical diagnosis,
- referral for a non-musculoskeletal problem,
- referral from hospital services.
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 |
|---|---|---|
| ICF-based cross-country comparative analysisICF-based cross-country comparative analysis | Other | Poland, Spain |
Primary outcome
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).
1 secondary outcome
Sociodemographic data of the sample (nationality, age, sex, education level, work status, number of comorbidities)
Time frame: 2024-01/2024-07
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 39532934Wisniowska-Szurlej A, Sozanska A, Barrio SJ, Sozanski B, Ceballos-Laita L, Hernandez-Lazaro H. ICF based comparison of musculoskeletal health in regions of Poland and Spain. Sci Rep. 2024 Nov 12;14(1):27671. doi: 10.1038/s41598-024-77450-2.
- Individual participant dataSharing planned: No
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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.
Agnieszka Wiśniowska-Szurlej, PhD principal investigator
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases or Conditions, run by University of Rzeszow at 1 site in Poland.
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 3 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Agnieszka Wiśniowska-Szurlej, PhD (+ 48 604 181 162, agwisniowska@ur.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief International Classification of Functioning, Disability and Health (ICF) core set for post-acute musculoskeletal conditions (time frame: 2024-01/2024-07). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06283407, which also lists 1 linked publication.
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 1 Mar 2024.