Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy

Musculoskeletal Diseases Clinical Trial

Official title:

Clinical Validation of the Content of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326229
• Other study ID #: CEIm 3096
• Status: Not yet recruiting
• Start date: May 6, 2024
• Est. completion date: September 26, 2025

Study information

• Verified date: April 2024
• Source: University of Valladolid
• Contact: Héctor Hernández Lázaro, PhD
• Phone: +34976645480
• Email: hhernandezl[@]saludcastillayleon.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this observational study is to validate the content of a tailored ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services.

The main question it aims to answer is:

• Are the ICF entities included in the ICF Core Set under evaluation useful from a clinical point of view?

Participants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition.

Description:

Primary care physiotherapy services provide community-based care for musculoskeletal conditions. These conditions are often associated with disability and impact on patients' quality of life. The International Classification of Functioning, Disability and Health (ICF) is the global framework for describing disability. ICF Core Sets are ICF-based tools that facilitate the clinical use of this classification. Some ICF Core Sets are designed to describe the functioning of patients with musculoskeletal problems.

These Core Sets are focused on the acute phase, typical of emergency care, and the post-acute phase, intended for multidisciplinary teams in rehabilitation centers. However, no ICF core set exists for the final stages of these conditions, when the patient has been reintegrated into the community. The development of ICF Core Sets follows a scientific process that integrates the perspectives of researchers, patients, professionals, and the care setting. Therefore, preparatory studies were carried out, taking as a reference the physiotherapy services in primary care, where most of these conditions are treated. A preliminary ICF core set was developed from these studies, the entities of which were agreed upon through a subsequent cross-sectional study involving a group of primary care physiotherapy experts. In order to confirm the usefulness of this ICF core set, a cross-sectional study will be developed to assess the clinical relevance of the ICF entities included in it.

A multicenter cross-sectional observational study will be carried out in primary care physiotherapy services to assess the relevance of various aspects of functioning in patients with musculoskeletal problems. The participants will be people suffering from musculoskeletal problems referred to these services for treatment by a general practitioner. The ICF core set will be used as outcome measure and the relevance of its ICF entities will be assessed by the participants. For this purpose, a 100 mm visual analog scale will be used, where 0 will mean "no problem" and 100 will mean "complete problem". Scores will be converted into ICF qualifiers. The criterion for confirming each ICF entity will be that it represents a problem in at least 5% of the sample. Confirmation of the ICF entities will allow the development of an ICF-based clinical tool for the management of musculoskeletal conditions in primary care physiotherapy services.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 385
• Est. completion date: September 26, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Patients diagnosed with a musculoskeletal condition by a general practitioner

• Patients with adequate knowledge of the Spanish language

Exclusion Criteria:

• Patients referred for a non-musculoskeletal problem

• Patients referred from hospital services

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Intervention

Other:
• ICF entities assessment
A visual analog scale will be used by the participants to evaluate the relevance of the ICF entities in relation to their musculoskeletal condition. The scale will range from 0 (no problem) to 100 (complete problem).

Locations

Country	Name	City	State
Spain	Ólvega Primary Care Physiotherapy service	Ólvega	Soria

Sponsors (2)

Lead Sponsor	Collaborator
University of Valladolid	Castilla-León Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Hernandez-Lazaro H, Jimenez-Del Barrio S, Ceballos-Laita L, Lahuerta-Martin S, Medrano-de-la-Fuente R, Hernando-Garijo I, Mingo-Gomez MT. Multicentre cross-sectional study assessing content validity of the International Classification of Functioning, disability and health core set for post-acute musculoskeletal conditions in primary care physiotherapy services. J Rehabil Med. 2023 Nov 16;55:jrm11950. doi: 10.2340/jrm.v55.11950. — View Citation

Hernandez-Lazaro H, Mingo-Gomez MT, Ceballos-Laita L, Medrano-de-la-Fuente R, Jimenez-Del Barrio S. Validation of the international classification of functioning, disability, and health (ICF) core sets for musculoskeletal conditions in a primary health care setting from physiotherapists' perspective using the Delphi method. Disabil Rehabil. 2023 Jul;45(15):2458-2468. doi: 10.1080/09638288.2022.2096128. Epub 2022 Jul 13. — View Citation

Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Lahuerta-Martin S, Hernando-Garijo I, Medrano-de-la-Fuente R, Ceballos-Laita L. Researcher's Perspective on Musculoskeletal Conditions in Primary Care Physiotherapy Units through the International Classification of Functioning, Disability, and Health (ICF): A Scoping Review. Biomedicines. 2023 Jan 20;11(2):290. doi: 10.3390/biomedicines11020290. — View Citation

Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Rodriguez-Fernandez AI, Areso-Boveda PB, Ceballos-Laita L. Validation of the International Classification of Functioning, Disability, and Health (ICF) core set for post-acute musculoskeletal conditions in a primary care physiotherapy setting from the perspective of patients using focus groups. Disabil Rehabil. 2023 Sep 5:1-8. doi: 10.1080/09638288.2023.2251392. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic data of the sample	Data set for the characterization of the sample (age, gender, education level, job and musculoskeletal diagnosis)	2024-05/2024-12
Primary	ICF core set for post-acute musculoskeletal conditions (adapted version for primary care physiotherapy services)	The ICF entities to be used have been obtained in an observational study with registry number NCT06168721. The list of categories will be available in this registry once the study is published.	2024-05/2024-12