NCT06283407

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

February 21, 2024

Last Update Submit

February 28, 2024

Conditions

Keywords

International Classification of Functioning, Disability and Health; Musculoskeletal Diseases;Disability EvaluationMusculoskeletal Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sociodemographic data of the sample (nationality, age, sex, education level, work status, number of comorbidities)

    2024-01/2024-07

Study Arms (2)

Poland

People with musculoskeletal conditions from the general population in Poland

Other: ICF-based cross-country comparative analysis

Spain

People with musculoskeletal conditions from the general population in Spain

Other: ICF-based cross-country comparative analysis

Interventions

ICF-based cross-country comparative analysis

PolandSpain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People with musculoskeletal conditions from the general population in Poland and Spain will be the potential participants in this study.

You may qualify if:

  • 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.

You may not qualify if:

  • mental disorders - depression or personality disorders confirmed by a medical diagnosis,
  • referral for a non-musculoskeletal problem,
  • referral from hospital services.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rzeszow

Rzeszów, 35-959, Poland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Agnieszka Wiśniowska-Szurlej, PhD

    University of Rzeszow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Wiśniowska-Szurlej, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 28, 2024

Study Start

March 4, 2024

Primary Completion

June 3, 2024

Study Completion

November 4, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations