Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Diseases
• Intervention / Treatment: Other: ICF entities assessment

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 385

Contacts and Locations

• Study Contact: Name: Héctor Hernández Lázaro, PhD; Phone Number: 38229 +34976645480; Email: hhernandezl@saludcastillayleon.es

Study Locations

• Spain
  • Soria
    • Ólvega, Soria, Spain, 42110
      • Recruiting
      • Ólvega Primary Care Physiotherapy service
      • Contact: Héctor Hernández Lázaro, PhD; Phone Number: 38229 +34976645480; Email: hhernandezl@saludcastillayleon.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Musculoskeletal patients; Patients suffering from musculoskeletal problems referred by a family physician for management in primary care physiotherapy services.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Valladolid
• Collaborators: Castilla-León Health Service
• Investigators: Study Chair: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): September 26, 2025

Study Registration Dates

• First Submitted: March 16, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Musculoskeletal Diseases, ICF, Primary Health Care, Physical Therapy Modalities
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: CEIm 3096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The authors confirm that the data supporting the findings of this study will be available within the article and/or its supplementary materials.
• IPD Sharing Time Frame: From the publication of the study, with no time limit.
• IPD Sharing Access Criteria: Access to this data will be conditioned by the type of publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No