Musculoskeletal DiseasesNCT06326229
Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy
An observational study of Musculoskeletal Diseases, run by University of Valladolid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- ICF entities assessment
- How many people
- 385 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jun 2024to 26 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years of age or older
- Patients diagnosed with a musculoskeletal condition by a general practitioner
- Patients with adequate knowledge of the Spanish language
Who cannot join
- Patients referred for a non-musculoskeletal problem
- Patients referred from hospital services
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Ólvega Primary Care Physiotherapy service
Ólvega, Soria, 42110
Héctor Hernández Lázaro, PhD, +34976645480 ext. 38229, hhernandezl@saludcastillayleon.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Diseases
- Being tested
- ICF entities assessment
- Keywords
- Musculoskeletal Diseases, ICF, Primary Health Care, Physical Therapy Modalities
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICF entities assessmentOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Musculoskeletal patients | Patients suffering from musculoskeletal problems referred by a family physician for management in primary care physiotherapy services. Receives: Other: ICF entities assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2024-05/2024-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start17 Jun 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion26 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service
- Responsible party
- Principal investigator, Héctor Hernández Lázaro, University of Valladolid
- Investigators
- Sandra Jiménez del Barrio, PhD, Study chair, University of ValladolidLuis Ceballos Laita, PhD, Study chair, University of ValladolidMaría Teresa Mingo Gómez, PhD, Study chair, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326229
- Sponsor's protocol ID
- CEIm 3096
- Status last verified
- Jun 2024
- First submitted
- 16 Mar 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The authors confirm that the data supporting the findings of this study will be available within the article and/or its supplementary materials.
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.
PubMed 35830343Hernandez-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.
PubMed 36830831Hernandez-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.
PubMed 37667886Hernandez-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.
PubMed 37974517
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Content of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services
- ClinicalTrials.gov ID
- NCT06326229
- Acronym / sponsor ID
- CEIm 3096
- Conditions
- Musculoskeletal Diseases
- Keywords
- Musculoskeletal Diseases, ICF, Primary Health Care, Physical Therapy Modalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Castilla-León Health Service
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 26 Sep 2025 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Musculoskeletal patients | – | Other: ICF entities assessmentPatients suffering from musculoskeletal problems referred by a family physician for management in primary care physiotherapy services. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Patients diagnosed with a musculoskeletal condition by a general practitioner
- Patients with adequate knowledge of the Spanish language
Key exclusion criteria (2 listed)
- Patients referred for a non-musculoskeletal problem
- Patients referred from hospital services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICF entities assessmentA 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). | Other | Musculoskeletal patients |
Primary outcome
ICF core set for post-acute musculoskeletal conditions (adapted version for primary care physiotherapy services)
Time frame: 2024-05/2024-12
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 35830343Hernandez-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.
- Background: PubMed 36830831Hernandez-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.
- Background: PubMed 37667886Hernandez-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.
- Background: PubMed 37974517Hernandez-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.
- Individual participant dataSharing planned: Yes. The authors confirm that the data supporting the findings of this study will be available within the article and/or its supplementary materials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Jiménez del Barrio, PhD study chair
University of Valladolid
Luis Ceballos Laita, PhD study chair
University of Valladolid
María Teresa Mingo Gómez, PhD study chair
University of Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Héctor Hernández Lázaro, PhD (+34976645480 ext. 38229, hhernandezl@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICF core set for post-acute musculoskeletal conditions (adapted version for primary care physiotherapy services) (time frame: 2024-05/2024-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326229, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.