Looking at chronic pain in adults with severe haemophilia A
Official title: Multidimensional Assessment of Chronic Pain in Severe Haemophilia A Treated With Monoclonal Antibodies: an Observational Study; an Ambispective Cohort Study
Run by Investigación en Hemofilia y Fisioterapia · NCT07096349 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 109 (estimated) |
| Sponsor | Investigación en Hemofilia y Fisioterapia Research network |
| Locations | 1 site (Oviedo, Principality of Asturias) |
| Status | Recruiting |
| Started | July 30, 2025 |
| Main results expected | October 3, 2025 |
| Study ends | October 26, 2025 |
| Registry record updated | August 1, 2025 |
| Trial ID | NCT07096349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.