Musculoskeletal DiseasesNCT06168721
ICF Core Set for Primary Care Physiotherapy
An observational study of Musculoskeletal Diseases, run by University of Valladolid at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 26 to 67 years
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Expert survey
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2024to 25 Jan 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 26 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The potential participants in this study should be physical therapists working in a primary care clinical setting. The resulting panel of experts would have sufficient expertise in this area. The study will focus on the Spanish region of 'Castilla and Leon', but efforts will be made to extend the scope to a national level.
Who may be able to join
- Be physiotherapists working in a primary care setting for the duration of the study.
- Have more than 5 years of experience in this clinical setting.
- Evidence of completion of at least 200 hours of additional training, teaching, research, and/or administrative activities related to the clinical setting.
Who cannot join
- Work in a rehabilitation center or hospital context.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services
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. The development of these tools follows a scientific process that combines the perspectives of researchers, patients, professionals, and the care setting. Our research team has conducted preliminary studies and identified candidate ICF categories with good potential for inclusion in a preliminary version of an ICF Core Set for the treatment of musculoskeletal conditions in community physical therapy settings. The aim of this study is to confirm the relevance of the candidate categories and to develop a final version of this ICF Core Set.
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 have been carried out, taking as a reference the physiotherapy services in primary care, where most of these conditions are treated.
These preparatory studies have made it possible to draw up a list of ICF categories that are candidates for being part of an ICF core set specific to these services. To confirm the relevance of these categories, a cross-sectional observational study will be developed by recruiting a group of experts. The experts will carry out two rounds of the survey according to the Delphi method. To be part of this group, sufficient expertise in the field of primary care physiotherapy will be required. The categories that reach consensus among these experts will be proposed in the development of a tailored ICF Core Set for primary care physiotherapy services.
The aim of this study is to confirm the relevance of the candidate categories and to develop a final version of an ICF Core Set for the management of musculoskeletal conditions in a primary care physiotherapy clinical setting. The availability of this tool would allow guiding physical therapy assessments, selecting optimal outcome measures, implementing person-centered care, and systematically recording clinical data.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Expert survey
- Keywords
- ICF, Musculoskeletal Diseases, Physical Therapy Modalities, Primary Health Care, Community Health Services
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert surveyOther
The expert group will participate in a two-round survey using the Delphi method. The first round aims to assess the relevance of the proposed ICF categories and to identify missing concepts. The second round will aim to confirm the appropriateness of including the selected categories in the ICF core set. Each round will last 3 weeks and the experts will be provided with feedback on the results obtained.
| Study group | Role | What they receive |
|---|---|---|
| Expert panel | This group will be composed of experts in primary care physiotherapy. Receives: Other: Expert survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relevance of candidate ICF categories (First Delphi Round)
The relevance of the categories will be measured on a 5-point Likert scale: "not relevant" (score 1), "hardly relevant" (score 2), "somewhat relevant" (score 3), "relevant" (score 4) and "very relevant" (score 5).
Measured: 2024-01/2024-06
Judgment on the clinical utility of the selected ICF categories (Second Delphi Round)
Dichotomous question (yes/no) on the appropriateness of including or excluding the most relevant ICF categories in the ICF core set.
Measured: 2024-01/2024-06
Secondary outcomes (1)
Missing functioning concepts (First Delphi Round)
Open-ended question related to ICF
Measured: 2024-01/2024-06
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start22 Jan 2024
- Primary completion24 Sep 2024
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Sanidad de Castilla y León
- 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
- NCT06168721
- Sponsor's protocol ID
- CEIm 2987
- Status last verified
- Feb 2025
- First submitted
- 4 Dec 2023
- Last updated
- 17 Feb 2025
- 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 37974517Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Simarro-Martin A, Wisniowska-Szurlej A, Ceballos-Laita L. Development of an ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services in Spain: a Delphi study. Disabil Rehabil. 2025 Sep;47(18):4759-4768. doi: 10.1080/09638288.2025.2460723. Epub 2025 Feb 11.
PubMed 39931756
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services
- ClinicalTrials.gov ID
- NCT06168721
- Acronym / sponsor ID
- CEIm 2987
- Conditions
- Musculoskeletal Diseases
- Keywords
- ICF, Musculoskeletal Diseases, Physical Therapy Modalities, Primary Health Care, Community Health Services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Sanidad de Castilla y León
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 13 Dec 2023 (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.
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. The development of these tools follows a scientific process that combines the perspectives of researchers, patients, professionals, and the care setting. Our research team has conducted preliminary studies and identified candidate ICF categories with good potential for inclusion in a preliminary version of an ICF Core Set for the treatment of musculoskeletal conditions in community physical therapy settings. The aim of this study is to confirm the relevance of the candidate categories and to develop a final version of this ICF Core Set.
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 have been carried out, taking as a reference the physiotherapy services in primary care, where most of these conditions are treated.
These preparatory studies have made it possible to draw up a list of ICF categories that are candidates for being part of an ICF core set specific to these services. To confirm the relevance of these categories, a cross-sectional observational study will be developed by recruiting a group of experts. The experts will carry out two rounds of the survey according to the Delphi method. To be part of this group, sufficient expertise in the field of primary care physiotherapy will be required. The categories that reach consensus among these experts will be proposed in the development of a tailored ICF Core Set for primary care physiotherapy services.
The aim of this study is to confirm the relevance of the candidate categories and to develop a final version of an ICF Core Set for the management of musculoskeletal conditions in a primary care physiotherapy clinical setting. The availability of this tool would allow guiding physical therapy assessments, selecting optimal outcome measures, implementing person-centered care, and systematically recording clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expert panel | – | Other: Expert surveyThis group will be composed of experts in primary care physiotherapy. |
Who may qualify
- Ages
- 26 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The potential participants in this study should be physical therapists working in a primary care clinical setting. The resulting panel of experts would have sufficient expertise in this area. The study will focus on the Spanish region of 'Castilla and Leon', but efforts will be made to extend the scope to a national level.
Key inclusion criteria (3 listed)
- Be physiotherapists working in a primary care setting for the duration of the study.
- Have more than 5 years of experience in this clinical setting.
- Evidence of completion of at least 200 hours of additional training, teaching, research, and/or administrative activities related to the clinical setting.
Key exclusion criteria (1 listed)
- Work in a rehabilitation center or hospital context.
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 |
|---|---|---|
| Expert surveyThe expert group will participate in a two-round survey using the Delphi method. The first round aims to assess the relevance of the proposed ICF categories and to identify missing concepts. The second round will aim to confirm the appropriateness of including the selected categories in the ICF core set. Each round will last 3 weeks and the experts will be provided with feedback on the results obtained. | Other | Expert panel |
Primary outcome
Relevance of candidate ICF categories (First Delphi Round)
Time frame: 2024-01/2024-06
The relevance of the categories will be measured on a 5-point Likert scale: "not relevant" (score 1), "hardly relevant" (score 2), "somewhat relevant" (score 3), "relevant" (score 4) and "very relevant" (score 5).
Judgment on the clinical utility of the selected ICF categories (Second Delphi Round)
Time frame: 2024-01/2024-06
Dichotomous question (yes/no) on the appropriateness of including or excluding the most relevant ICF categories in the ICF core set.
1 secondary outcome
Missing functioning concepts (First Delphi Round)
Time frame: 2024-01/2024-06
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- 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.
- Results publication: PubMed 39931756Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Simarro-Martin A, Wisniowska-Szurlej A, Ceballos-Laita L. Development of an ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services in Spain: a Delphi study. Disabil Rehabil. 2025 Sep;47(18):4759-4768. doi: 10.1080/09638288.2025.2460723. Epub 2025 Feb 11.
- 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 1 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: finished, as of the sponsor's last update on 17 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relevance of candidate ICF categories (First Delphi Round) (time frame: 2024-01/2024-06). The study lists 2 primary outcomes in all. 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 NCT06168721, which also lists 5 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 17 Feb 2025.