Studies chronic pain in adults with severe haemophilia A treated with antibodies
Looks at lasting pain and related thoughts in adults with severe haemophilia A on treatment.
Plain-language title generated from the registry record
Registry title: Multidimensional Assessment of Chronic Pain in Severe Haemophilia A
Key facts
- Where
- Oviedo, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe haemophilia A who have joint damage and have been treated with bispecific monoclonal antibodies for at least 3 months.
- Age
- Over 18 years
- Sex
- Men only
- Disease stage
- Severe haemophilia A (FVIII < 1%) with haemophilic joint disease in at least two lower limb joints and 5 points or more on the Haemophilia Joint Health Score.
- Earlier treatment
- At least 3 months of treatment with bispecific monoclonal antibodies.
- Biomarker or test result
- No inhibitors to FVIII concentrates at the time of the study.
Main reasons for not taking part
- Severe muscle, bone or nerve conditions that cause chronic pain
- Nerve or thinking problems that make it hard to understand the questionnaires
- Took part in an interventional clinical study in the 6 months before this study
Read by machine on 9 November 2026.
Where in Spain
- Universidad de OviedoOviedo, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Investigación en Hemofilia y Fisioterapia
- Trial code
- NCT07096349
- Record updated
- 1 August 2025
- Original description
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.Read full original descriptionShow less
Multidimensional Assessment of Chronic Pain in Severe Haemophilia A Treated With Monoclonal Antibodies: an Observational Study; an Ambispective Cohort Study
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.
Inclusion: 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: Patients who have participated in an interventional clinical study in the 6 months prior to the study; Patients diagnosed with severe musculoskeletal or neurological comorbidities causing chronic pain; Individuals with neurological or cognitive impairments that prevent them from understanding the questionnaires.