ICF-based Comparison on Musculoskeletal Health in Poland and Spain

Musculoskeletal Diseases or Conditions Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283407
• Other study ID #: ICF
• Status: Not yet recruiting
• Start date: March 4, 2024
• Est. completion date: November 4, 2024

Study information

• Verified date: February 2024
• Source: University of Rzeszow
• Contact: Agnieszka Wisniowska-Szurlej, PhD
• Phone: + 48 604 181 162
• Email: agwisniowska[@]ur.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: November 4, 2024
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Musculoskeletal Diseases
• Musculoskeletal Diseases or Conditions

Intervention

Other:
• ICF-based cross-country comparative analysis
ICF-based cross-country comparative analysis

Locations

Country	Name	City	State
Poland	University of Rzeszow	Rzeszów

Sponsors (2)

Lead Sponsor	Collaborator
University of Rzeszow	Sanidad de Castilla y León

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2024-01/2024-07
Secondary	Sociodemographic data of the sample (nationality, age, sex, education level, work status, number of comorbidities)		2024-01/2024-07