Looking at chronic pain in adults with severe haemophilia A
Multidimensional Assessment of Chronic Pain in Severe Haemophilia A Treated With Monoclonal Antibodies: an Observational Study; an Ambispective Cohort Study
This project will see if chronic pain in adults with severe haemophilia A who have been on bispecific monoclonal antibodies is linked to pain catastrophising, confidence in managing pain, and body image.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 109 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Investigación en Hemofilia y Fisioterapia Research network |
| Locations | 1 site (Oviedo, Principality of Asturias) |
| Trial ID | NCT07096349 on ClinicalTrials.gov |
What this trial studies
This is a multicentre cross-sectional cohort of 109 adults with severe haemophilia A recruited from regions of Spain, with data collected at the Universidad de Oviedo. The primary outcome is chronic residual pain and its functional interference measured with the Brief Pain Inventory-Short Form. Secondary measures include the Pain Catastrophising Scale, a Pain Self-Efficacy questionnaire, and assessments of body image and visible disability. Eligibility requires ≥3 months on bispecific monoclonal antibody therapy, haemophilic arthropathy in at least two lower-limb joints with a Haemophilia Joint Health Score ≥5, no FVIII inhibitors, and ability to complete self-report questionnaires.
Who should consider this trial
Good fit: Adults (≥18 years) with severe haemophilia A (FVIII <1%), no FVIII inhibitors, at least three months of treatment with bispecific monoclonal antibodies, haemophilic arthropathy in two or more lower-limb joints with HJHS ≥5, and the ability to complete questionnaires.
Not a fit: People with severe unrelated musculoskeletal or neurological conditions causing chronic pain, cognitive impairment that prevents questionnaire completion, recent participation in an interventional trial, or those not treated with bispecific monoclonal antibodies are unlikely to benefit from these findings.
Why it matters
Potential benefit: If successful, the findings could help tailor pain-management and psychosocial support strategies to improve daily function and quality of life for people with severe haemophilia A.
How similar studies have performed: Observational work in chronic pain populations and some haemophilia cohorts has shown links between catastrophising, self-efficacy, and pain outcomes, but applying these measures specifically in patients on bispecific monoclonal antibodies is relatively new.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oviedo, Principality of Asturias
- Universidad de Oviedo — Oviedo, Principality of Asturias, Spain (Recruiting)
Study contacts
- Principal investigator: Rubén Cuesta-Barriuso, PhD — Universidad de Oviedo
- Study coordinator: Rubén Cuesta-Barriuso, PhD
- Email: cuestaruben@uniovi.es
- Phone: 0034 985103386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.