Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy

NCT06326229 | Recruiting

• 1 other identifier: CEIm 3096
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Musculoskeletal Diseases

Keywords

Musculoskeletal Diseases, ICF, Primary Health Care, Physical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Sociodemographic data of the sample

  2024-05/2024-12

Study Arms (1)

Musculoskeletal patients

Patients suffering from musculoskeletal problems referred by a family physician for management in primary care physiotherapy services.

Other: ICF entities assessment

Interventions

ICF entities assessment OTHER

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).

Musculoskeletal patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be the group of patients referred by a general practitioner to physiotherapy services in primary care for the management of musculoskeletal problems.

You may qualify if:

• years of age or older
• Patients diagnosed with a musculoskeletal condition by a general practitioner
• Patients with adequate knowledge of the Spanish language

You may not qualify if:

• Patients referred for a non-musculoskeletal problem
• Patients referred from hospital services

Sponsors & Collaborators

• University of Valladolid: lead
• Castilla-León Health Service: collaborator

Study Sites (1)

Ólvega Primary Care Physiotherapy service

Ólvega, Soria, 42110, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 35830343 BACKGROUND

• 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.

  PMID: 36830831 BACKGROUND

• 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. 2024 Aug;46(16):3594-3601. doi: 10.1080/09638288.2023.2251392. Epub 2023 Sep 5.

  PMID: 37667886 BACKGROUND

• 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.

  PMID: 37974517 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Sandra Jiménez del Barrio, PhD

  University of Valladolid

  STUDY CHAIR

• Luis Ceballos Laita, PhD

  University of Valladolid

  STUDY CHAIR

• María Teresa Mingo Gómez, PhD

  University of Valladolid

  STUDY CHAIR

Central Study Contacts

Héctor Hernández Lázaro, PhD

CONTACT

+34976645480; hhernandezl@saludcastillayleon.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: June 17, 2024
• Primary Completion: January 31, 2025
• Study Completion: September 26, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From the publication of the study, with no time limit.
• Access Criteria: Access to this data will be conditioned by the type of publication.

Locations

ES (1)