Pain and Joint Status With Psychosocial Factors in Patients With Hemophilia

NCT04715100 | Unknown

• 1 other identifier: He-Perception
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemophilia Arthropathy

Keywords

Hemophilic arthropathy; Educational intervention; Joint pain; Quality of life; Anxiety; Stress

Outcome Measures

Primary Outcomes (2)

• Assess the perception of joint pain with numerical scale of pain

  Measurement with numerical scale of pain. The patient must assign pain to a numerical value between two extreme points (0 to 10). Although the subject is asked to use numerical values to indicate the level of pain, the use of keywords, as well as previous instructions, are necessary if we expect the patient to conceptualize their pain in numerical terms. The scale is discrete, not continuous, but to perform statistical analyzes, equal intervals can be assumed between categories (score 0-10; higher scores mean a worse joint pain).

  Screening visit

• Assess the joint status with Hemophilia Joint Health Score

  Measurement the joint status with the instrument: Haemophilia Joint Health Score (score 0-120; higher scores mean a worse joint status).

  Screening visit

Secondary Outcomes (4)

• Assess the perception of quality of life with the questtionaire Short Form 36 Health Survey

  Screening visit

• Assess the list of roles with Oakley scale

  Screening visit

• Assess the carrying out activities of daily living

  Screening visit

• Assess the instrumental activities of daily living

  Screening visit

Study Arms (1)

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.

Other: Observational group

Interventions

Observational group 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).

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hemophilia attending in hemophilia Associations into Spanish Federation of Hemophilia (Fedhemo).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

University of Murcia

Murcia, 30006, Spain

Location

Related Publications (1)

• Seoane-Martin ME, Cuesta-Barriuso R, Rodriguez-Martinez MC. Performance of instrumental activities of daily living in patients with haemophilic arthropathy. A cross-sectional cohort study. Haemophilia. 2024 Nov;30(6):1406-1413. doi: 10.1111/hae.15114. Epub 2024 Oct 24.

  PMID: 39447049 DERIVED

MeSH Terms

Conditions

Arthralgia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: April 5, 2022
• Primary Completion: June 30, 2022
• Study Completion: November 1, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)