Pain and Joint Status With Psychosocial Factors in Patients With Hemophilia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-05

Study Completion Date

2022-11-01

Brief Summary

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Background. The recurrence of hemarthrosis in patients with congenital coagulopathies favors the development of a progressive, degenerative intra-articular lesion (hemophilic arthropathy) that mainly affects the knees, ankles and elbows. Disability and functional limitations are characteristic sequelae of these patients from an early age.

Objective. To assess the joint status, the perception of quality of life, the performance of roles and the performance of daily life activities, in patients with hemophilic arthropathy.

Study design. Observational, multicenter study. Method. 70 patients with hemophilia A and B will be included in this study. Patients will be recruited from 4 centers in different regions of Spain. The dependent variables will be: pain (measured with the Visual Analogue Scale), joint status (Hemophilia Joint Health Score), perception of quality of life (SF-36 questionnaire), list of roles, performance of daily life activities (Barthel scale), performing the instrumental activities of daily life (Lawton and Brody scale). The evolution of the variables will be analyzed using parametric (t-student or ANOVA) or non-parametric (Wilcoxon or Friedman) tests. A correlation analysis will be carried out between the dependent and independent variables, as well as a linear regression analysis between the observed determining variables.

Expected results. The aim is to observe the relationship of pain and joint status in patients with hemophilic arthropathy, with their perception of quality of life, the development of the roles they play and the performance of basic and instrumental activities of daily living.

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Detailed Description

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Main objective: To analyze the relationship of pain and joint status with psychosocial and functional variables in adult patients with hemophilic arthropathy.

Secondary objectives: i) To detect the relationship between joint damage in psychosocial disorders in patients with hemophilia; ii) Evaluate the performance and perception of roles with the clinical situation of patients with hemophilic arthropathy; iii) Identify the factors that influence the performance of basic and instrumental activities of daily living in adult patients with hemophilia; iv) Observe changes in the perception of quality of life, performance of roles and activities of daily life based on the clinical and sociodemographic characteristics of patients with hemophilia.

Patients who meet the selection criteria will be summoned to a meeting where the principal investigator will present, orally and in writing, the characteristics of the investigator, the intended objectives and the risks of the intervention. At said meeting, the following documentation will be provided: patient information document and informed consent document for patients.

After obtaining the informed consent of the patients, the evaluations will be carried out in the dependencies of the locations included in the study. Six dependent variables will be measured: pain, joint condition, perception of quality of life, list of roles, performance of basic activities of daily life, and performance of instrumental activities of daily life.

All joint state evaluations will be performed by the same physiotherapist, blinded to the objectives of the study. The evaluation of the questionnaires will be analyzed by another evaluator, blinded to the objectives of the study.

Conditions

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Hemophilia Arthropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

The inclusion criteria to participate in the present study are patients: with a diagnosis of hemophilia A and B; adults; and on a prophylactic or on-demand treatment regimen with FVIII / FIX concentrates.

For their part, patients with: neurological or cognitive alterations that impede understanding of the questionnaires will be excluded from the study; Dependent patients who require help from a third person to get around; patients who have developed a hemarthros in the 4 weeks prior to the study; and those who have not signed the informed consent document.

For inclusion in the study, patients will continue to be administered the dose of FVIII / FIX concentrates, following the guidelines of the medical criteria established by their reference hematologist. Throughout this study, the medical criteria for drug treatment, the dosage, and the replacement treatment periods will not be changed.

Observational group

Intervention Type OTHER

The study dependent variables will be: pain (vas scale), joint status (Hemophilia Joint Health Score), perception of quality of life (SF-36 questionnaire), list of roles (Oakley questionnaire), performance of basic activities of daily life (Barthel index) and the performance of instrumental activities of daily living (Lawton and Brody scale).

Interventions

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Observational group

The study dependent variables will be: pain (vas scale), joint status (Hemophilia Joint Health Score), perception of quality of life (SF-36 questionnaire), list of roles (Oakley questionnaire), performance of basic activities of daily life (Barthel index) and the performance of instrumental activities of daily living (Lawton and Brody scale).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with hemophilia A and B
* Patients of legal age
* Patients on prophylactic or on demand treatment with clotting factor concentrates.

Exclusion Criteria

* Patients with neurological or cognitive disorders that impede the understanding of the questionnaires
* Dependent patients who require help from a third person to get around
* Patients who have developed a hemarthros in the 4 weeks prior to the study.
* Patients who have not signed the informed consent document.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes