An observational study in Musculoskeletal Diseases, sponsored by University of Valladolid. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by University of Valladolid · Observational
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:
Participants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition.
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.
752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.
This study's planned enrollment of 385 is above the median of 120 across 207 observational studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →University of Valladolid is the lead sponsor of 34 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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).
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.
Time frame: 2024-05/2024-12
Sociodemographic data of the sample
Data set for the characterization of the sample (age, gender, education level, job and musculoskeletal diagnosis)
Time frame: 2024-05/2024-12
Plan to share: Yes — The authors confirm that the data supporting the findings of this study will be available within the article and/or its supplementary materials.
Supporting information: Study protocol, Statistical analysis plan
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.
Started Jun 2024 (actual). Primary completion is estimated for Jan 2025, 7 months after the start.
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University of Valladolid