Musculoskeletal Diseases or ConditionsNCT04135976
Applicability of the ICF in Primary Care Physiotherapy Units in the Health Service of Castille and Leon (Spain)
An observational study of Musculoskeletal Diseases or Conditions, run by University of Valladolid at 1 site in Spain.
Trial summary
The primary care physiotherapy units of the Spanish health service in Castille and Leon (SACYL) are responsible for providing physiotherapy treatments to the general population. Being part of the primary health care system, the actions of these units are aimed at the treatment of common conditions that do not involve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases or Conditions
- How many people
- 401 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 30 Jun 2023
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General population over 18 years of age that has been treated in a physiotherapy unit in primary care during the last year, or is going to be treated in these units during the development of this research project.
Who may be able to join
- Primary care studies over adult general population in developed Western countries
- Published in a peer-review journal
- Published since 2009
- Type of publication: random controlled trials, controlled clinical trial, cross-sectional study, observational study and qualitative study
- Physiotherapists with at least two years of professional experience in primary health care.
- Qualitative study
Show all 9Show fewer
- Treated in a physiotherapy unit during the past year.
- Over 18 years old
- Patients over 18 years referred to a primary care physiotherapy unit
Who cannot join
- Studies based solely in specific health problems
- Studies not conducted over general population (some kind of selection based on ethnicity, sex, social class, etc. have been made).
- Studies with hospitalized participants
- Studies published in a language other than English or Spanish
- Expert survey:
- Inability to concentrate for 30 minutes.
Show all 10Show fewer
- Insufficient knowledge of the Spanish language.
- Empirical multicenter study:
- Inability to concentrate for 30 minutes.
- Insufficient knowledge of the Spanish language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applicability of the International Classification of Functioning, Disability and Health (ICF) in Primary Care Physiotherapy Units in the Health Service of Castille and Leon (Spain)
The primary care physiotherapy units of the Spanish health service in Castille and Leon (SACYL) are responsible for providing physiotherapy treatments to the general population. Being part of the primary health care system, the actions of these units are aimed at the treatment of common conditions that do not involve severity, frequently musculoskeletal disorders.
The work of physiotherapists is closely related to the functionality of patients and, in this sense, the World Health Organization (WHO) has proposed the International Classification of Functioning, Disability and Health (ICF) as a conceptual framework to characterize the functional status of individuals.
Read more
The use of ICF in the clinical setting is not sufficiently widespread due to the the difficulties that the use of such an exhaustive classification implies in practice. In an attempt to address this problem, the WHO has encouraged the development of reduced versions aimed at responding to specific conditions or care contexts.
The idea behind the development of core sets is that it is possible to select a number of categories so as to capture the essence of a given clinical process, allowing an agile use of the ICF. However, in order to put these core sets into practice, it is necessary to check that the selected categories are valid from the perspective of the participants in the clinical processes.
The purpose of this research project is to determine whether the musculoskeletal core sets of the ICF are applicable in SACYL primary care physiotherapy units. This implies knowing if the categories already selected in these sets are representative of the health aspects considered as most relevant in the clinical context of physiotherapy in primary care.
To achieve this, four studies will be conducted to capture the perspective of patients, physiotherapists, researchers and clinical practice. This information will be translated into the language of the ICF to obtain comparable categories with those present in the core sets.
In this way, this research project will make possible to validate or adapt the core sets of the ICF for musculoskeletal conditions, in a specific clinical context of physiotherapy in primary care.
Read the detailed description
Preliminary studies will attempt to capture the perspectives of all agents involved in the SACYL primary care physiotherapy clinical processes.
The perspective of the patients will be collected by means of a qualitative study through focal groups of people who have been attended in physiotherapy units in primary care. Each focus group will be made up of five patients who will be provided with information about the ICF and will be encouraged to express themselves on the aspects that they consider most relevant when they are attended in primary care physiotherapy units. The duration of these focus groups will be 30 minutes and as many groups as necessary will be conducted to reach 100% saturation. The information obtained will be translated into second level categories of the ICF, so that it can be compared with those present in the already existing core sets.
The perspective of the physiotherapists will be gathered through a Delphi study. Physiotherapists with experience in the care context under study will be selected and the information will be collected through online surveys. Three rounds will be carried out, translating the information obtained into second level categories of the ICF, and providing feedback in each round to the participants.
The research perspective will be studied through a systematic review of the scientific literature. To this end, the main databases will be scrutinized and studies that investigate musculoskeletal conditions will be selected in a context compatible with that of physiotherapy in primary care. The data will be obtained through the outcome measures used in these studies, including those with an agreement level equal to or greater than 5%. This information will be translated into second level categories of the ICF, allowing us to know which of them are more relevant.
The clinical point of view will be captured in a transversal study in which a sample of patients receiving physiotherapy services in primary care will be taken. These patients must make an assessment of the categories present in the ICF checklist. This list will be complemented with the categories of the core sets for musculoskeletal conditions and with those detected in the previous studies. The participants will assign a qualifier to each category, depending on the importance they attach to it. In this study, patients will also be assessed using a generic test that measures the degree of functionality. Aspects such as the presence of cognitive deficit, depression and quality of life will also be considered. The measurement instruments will be selected from the results obtained in the bibliographic review described above. The number of patients required is estimated at 50 individuals belonging to different basic health areas. The data obtained will be analysed and translated into the language of the ICF (second level categories).
The categories derived from the set of previous studies will be compared with those present in the core sets of the ICF for musculoskeletal conditions. Three types of results are expected to be obtained: categories coincident in both groups of data, categories detected in the studies carried out but absent in the core sets; and categories not detected but present in the core sets.
In this way, it will be possible to determine the best way to establish the use of the ICF in the primary care physiotherapy units of SACYL.
- Conditions
- Musculoskeletal Diseases or Conditions
- Keywords
- physiotherapy, primary health care, ICF, core set validation, musculoskeletal conditions
- Medical subject headings
- Musculoskeletal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Most important issues related to functional status, disability and health in the treatment of musculoskeletal conditions in primary care, according to the ICF, reported in the scientific literature.
The measurement instruments used by primary care researchers will be broken down into units of meaning and converted into ICF categories using the conversion rules proposed by Cieza et al. The primary result is the achievement of the categories considered most relevant by primary care researchers.
Measured: 2022/05 - 2022/09
Most important issues related to functional status, disability and health in general population treated in physical therapy units for musculoskeletal conditions reported by physiotherapists in an online survey (expert survey).
The primary outcome will be a set of ICF categories that will be representative of the physiotherapists' perspective. The Delphy study will gather information from physioterapists working in a primary care set. This information will be converted into ICF categories using the conversion rules.
Measured: 2020/06 - 2021/03
Most important issues related to functional status, disability and health in general population treated in physical therapy units for musculoskeletal conditions reported by these patients in focus groups (qualitative study).
The primary outcome will be a set of ICF categories that will be representative of the patients' perspective. The focus groups will provide information about the point of view of the patients treated in primary care physioterapy units. Using the conversion rules, the information will be translated into ICF categories.
Measured: 2022/05 - 2022/12
Most important issues related to functional status, disability and health in patients treated in physical therapy units for musculoskeletal conditions, assessed by the comprehensive musculoskeletal ICF core set (empirical multicenter study).
Physiotherapists will evaluate a group of patients using the comprehensive ICF core set for post-acute musculoskeletal conditions. These patients will be asked to assess the relevance of the categories included in the ICF core set, according to their health problem. A 0-100 mm visual analog scale (VAS) will be used to rate each ICF category (a score of 5 or higher would validate the ICF category). The primary outcome will be the percentage of validated categories included in the ICF core set.
Measured: 2022/05 - 2023/03
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Jun 2020
- Primary completion1 Feb 2023
- Study completion30 Jun 2023
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 Diseases or ConditionsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 401 participants (actual)
- Target duration
- 6 Months
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
- María Teresa Mingo Gómez, Study director, University of ValladolidHéctor Hernández Lázaro, Principal investigator, University of ValladolidSandra Jiménez del Barrio, Study director, University of ValladolidLuis Ceballos Laita, Study director, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135976
- Sponsor's protocol ID
- CEIC 2231
- Status last verified
- Dec 2023
- First submitted
- 17 Oct 2019
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of the International Classification of Functioning, Disability and Health (ICF) in Primary Care Physiotherapy Units in the Health Service of Castille and Leon (Spain)
- ClinicalTrials.gov ID
- NCT04135976
- Acronym / sponsor ID
- CEIC 2231
- Conditions
- Musculoskeletal Diseases or Conditions
- Keywords
- physiotherapy, primary health care, ICF, core set validation, musculoskeletal conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Sanidad de Castilla y León
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Oct 2019 (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 primary care physiotherapy units of the Spanish health service in Castille and Leon (SACYL) are responsible for providing physiotherapy treatments to the general population. Being part of the primary health care system, the actions of these units are aimed at the treatment of common conditions that do not involve severity, frequently musculoskeletal disorders.
The work of physiotherapists is closely related to the functionality of patients and, in this sense, the World Health Organization (WHO) has proposed the International Classification of Functioning, Disability and Health (ICF) as a conceptual framework to characterize the functional status of individuals.
The use of ICF in the clinical setting is not sufficiently widespread due to the the difficulties that the use of such an exhaustive classification implies in practice. In an attempt to address this problem, the WHO has encouraged the development of reduced versions aimed at responding to specific conditions or care contexts.
The idea behind the development of core sets is that it is possible to select a number of categories so as to capture the essence of a given clinical process, allowing an agile use of the ICF. However, in order to put these core sets into practice, it is necessary to check that the selected categories are valid from the perspective of the participants in the clinical processes.
The purpose of this research project is to determine whether the musculoskeletal core sets of the ICF are applicable in SACYL primary care physiotherapy units. This implies knowing if the categories already selected in these sets are representative of the health aspects considered as most relevant in the clinical context of physiotherapy in primary care.
To achieve this, four studies will be conducted to capture the perspective of patients, physiotherapists, researchers and clinical practice. This information will be translated into the language of the ICF to obtain comparable categories with those present in the core sets.
In this way, this research project will make possible to validate or adapt the core sets of the ICF for musculoskeletal conditions, in a specific clinical context of physiotherapy in primary care.
Detailed description
Preliminary studies will attempt to capture the perspectives of all agents involved in the SACYL primary care physiotherapy clinical processes.
The perspective of the patients will be collected by means of a qualitative study through focal groups of people who have been attended in physiotherapy units in primary care. Each focus group will be made up of five patients who will be provided with information about the ICF and will be encouraged to express themselves on the aspects that they consider most relevant when they are attended in primary care physiotherapy units. The duration of these focus groups will be 30 minutes and as many groups as necessary will be conducted to reach 100% saturation. The information obtained will be translated into second level categories of the ICF, so that it can be compared with those present in the already existing core sets.
The perspective of the physiotherapists will be gathered through a Delphi study. Physiotherapists with experience in the care context under study will be selected and the information will be collected through online surveys. Three rounds will be carried out, translating the information obtained into second level categories of the ICF, and providing feedback in each round to the participants.
The research perspective will be studied through a systematic review of the scientific literature. To this end, the main databases will be scrutinized and studies that investigate musculoskeletal conditions will be selected in a context compatible with that of physiotherapy in primary care. The data will be obtained through the outcome measures used in these studies, including those with an agreement level equal to or greater than 5%. This information will be translated into second level categories of the ICF, allowing us to know which of them are more relevant.
The clinical point of view will be captured in a transversal study in which a sample of patients receiving physiotherapy services in primary care will be taken. These patients must make an assessment of the categories present in the ICF checklist. This list will be complemented with the categories of the core sets for musculoskeletal conditions and with those detected in the previous studies. The participants will assign a qualifier to each category, depending on the importance they attach to it. In this study, patients will also be assessed using a generic test that measures the degree of functionality. Aspects such as the presence of cognitive deficit, depression and quality of life will also be considered. The measurement instruments will be selected from the results obtained in the bibliographic review described above. The number of patients required is estimated at 50 individuals belonging to different basic health areas. The data obtained will be analysed and translated into the language of the ICF (second level categories).
The categories derived from the set of previous studies will be compared with those present in the core sets of the ICF for musculoskeletal conditions. Three types of results are expected to be obtained: categories coincident in both groups of data, categories detected in the studies carried out but absent in the core sets; and categories not detected but present in the core sets.
In this way, it will be possible to determine the best way to establish the use of the ICF in the primary care physiotherapy units of SACYL.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population over 18 years of age that has been treated in a physiotherapy unit in primary care during the last year, or is going to be treated in these units during the development of this research project.
Key inclusion criteria (9 listed)
- Primary care studies over adult general population in developed Western countries
- Published in a peer-review journal
- Published since 2009
- Type of publication: random controlled trials, controlled clinical trial, cross-sectional study, observational study and qualitative study
- Physiotherapists with at least two years of professional experience in primary health care.
Key exclusion criteria (10 listed)
- Studies based solely in specific health problems
- Studies not conducted over general population (some kind of selection based on ethnicity, sex, social class, etc. have been made).
- Studies with hospitalized participants
- Studies published in a language other than English or Spanish
- Inability to concentrate for 30 minutes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Most important issues related to functional status, disability and health in the treatment of musculoskeletal conditions in primary care, according to the ICF, reported in the scientific literature.
Time frame: 2022/05 - 2022/09
The measurement instruments used by primary care researchers will be broken down into units of meaning and converted into ICF categories using the conversion rules proposed by Cieza et al. The primary result is the achievement of the categories considered most relevant by primary care researchers.
Most important issues related to functional status, disability and health in general population treated in physical therapy units for musculoskeletal conditions reported by physiotherapists in an online survey (expert survey).
Time frame: 2020/06 - 2021/03
The primary outcome will be a set of ICF categories that will be representative of the physiotherapists' perspective. The Delphy study will gather information from physioterapists working in a primary care set. This information will be converted into ICF categories using the conversion rules.
Most important issues related to functional status, disability and health in general population treated in physical therapy units for musculoskeletal conditions reported by these patients in focus groups (qualitative study).
Time frame: 2022/05 - 2022/12
The primary outcome will be a set of ICF categories that will be representative of the patients' perspective. The focus groups will provide information about the point of view of the patients treated in primary care physioterapy units. Using the conversion rules, the information will be translated into ICF categories.
Most important issues related to functional status, disability and health in patients treated in physical therapy units for musculoskeletal conditions, assessed by the comprehensive musculoskeletal ICF core set (empirical multicenter study).
Time frame: 2022/05 - 2023/03
Physiotherapists will evaluate a group of patients using the comprehensive ICF core set for post-acute musculoskeletal conditions. These patients will be asked to assess the relevance of the categories included in the ICF core set, according to their health problem. A 0-100 mm visual analog scale (VAS) will be used to rate each ICF category (a score of 5 or higher would validate the ICF category). The primary outcome will be the percentage of validated categories included in the ICF core set.
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 12 Dec 2023.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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: No
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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.
María Teresa Mingo Gómez study director
University of Valladolid
Héctor Hernández Lázaro principal investigator
University of Valladolid
Sandra Jiménez del Barrio study director
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 or Conditions, 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 9 inclusion and 10 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 12 Dec 2023. 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?
Most important issues related to functional status, disability and health in the treatment of musculoskeletal conditions in primary care, according to the ICF, reported in the scientific literature. (time frame: 2022/05 - 2022/09). The study lists 4 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 NCT04135976, 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 12 Dec 2023.