Multidimensional Assessment of Chronic Pain in Severe Haemophilia A

NCT ID: NCT07096349

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2025-10-26

Brief Summary

Introduction: Haemophilia is a congenital coagulopathy characterised by haemarthrosis, mainly in the knees, ankles and elbows. Prophylactic treatment is the most effective therapeutic option for preventing or minimising these bleeds. Bispecific monoclonal antibodies have been shown to be effective in reducing bleeding in patients with haemophilia.

Objectives: To investigate the associations between chronic residual pain and pain catastrophising, perceived self-efficacy regarding the disease and treatment, and body image and perception of visible disability.

Methods. Multicentre cross-sectional cohort studies. 109 patients with severe haemophilia A from different regions of Spain will be included in the study. The primary variable will be chronic residual pain and its functional interference (Brief Pain Inventory-Short Form). Secondary variables will be pain catastrophising (Pain Catastrophising Scale), perceived self-efficacy regarding the disease and treatment (Pain Self-Efficacy Questionnaire), and body image and perception of visible disability (Body Image Scale). Potential confounding variables will include sociodemographic variables (age and educational level), clinical variables (time on monoclonal antibody treatment and number of previous bleeds in the last 12 months) and anthropometric variables (body mass index).

Expected results: It is expected that residual chronic pain will persist in patients with severe haemophilia A treated with monoclonal antibodies and that it will be associated with greater catastrophising, lower self-efficacy and poorer body image, modulating the experience of pain beyond bleeding control.

Conditions

Hemophilia A Without Inhibitor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Observational group

Patients with severe haemophilia A from different regions of Spain will be included in the study. Patients who meet the selection criteria will be informed of the characteristics and objectives of the study. They will be provided with an information and informed consent document. After confirming that they do not meet any of the exclusion criteria, the primary and secondary dependent variables and confounding factors will be assessed

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years of age.
• With a medical diagnosis of severe haemophilia A (FVIII < 1%).
• No inhibitors to FVIII concentrates at the time of the study.
• At least 3 months of treatment with bispecific monoclonal antibodies.
• Medical diagnosis of haemophilic arthropathy in at least two lower limb joints and ≥5 points on the Haemophilia Joint Health Score.
• Ability to understand and respond to self-administered questionnaires.

Exclusion Criteria

• Patients diagnosed with severe musculoskeletal or neurological comorbidities causing chronic pain.
• Individuals with neurological or cognitive impairments that prevent them from understanding the questionnaires.
• Patients who have participated in an interventional clinical study in the 6 months prior to the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Investigación en Hemofilia y Fisioterapia

NETWORK

Sponsor Role: lead

Responsible Party

Rubén Cuesta-Barriuso

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Oviedo

Locations

Universidad de Oviedo

Oviedo, Principality of Asturias, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Rubén Cuesta-Barriuso, PhD

Role: CONTACT

cuestaruben@uniovi.es

0034 985103386

Facility Contacts

Rubén Cuesta-Barriuso

Role: primary

cuestaruben@uniovi.es

607547274

Other Identifiers

He-MoN

Identifier Type: -

Identifier Source: org_study_id