Actively Recruiting

Age: 18Years +
MALE
NCT07096349

Multidimensional Assessment of Chronic Pain in Severe Haemophilia A

Led by Investigación en Hemofilia y Fisioterapia · Updated on 2025-08-01

109

Participants Needed

1

Research Sites

12 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Multidimensional Assessment of Chronic Pain in Severe Haemophilia A

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age.
  • Diagnosed with severe haemophilia A (factor VIII less than 1%).
  • No inhibitors to factor VIII concentrates at the time of the study.
  • Treated with bispecific monoclonal antibodies for at least 3 months.
  • Diagnosed with haemophilic arthropathy in at least two lower limb joints with a Haemophilia Joint Health Score of 5 or more.
  • Able to understand and complete self-administered questionnaires.
Not Eligible

You will not qualify if you...

  • Diagnosed with severe musculoskeletal or neurological conditions causing chronic pain.
  • Have neurological or cognitive impairments that prevent understanding of questionnaires.
  • Participated in an interventional clinical study within 6 months prior to this study.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universidad de Oviedo

Oviedo, Principality of Asturias, Spain, 33006

Actively Recruiting

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Research Team

R

Rubén Cuesta-Barriuso, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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