Multidimensional Assessment of Chronic Pain in Severe Haemophilia A

NCT07096349 | Recruiting

• 1 other identifier: He-MoN
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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

Keywords

Hemophilia; Bispecific monoclonal antibodies; Chronic pain; Catastrophising; Self-efficacy; Body image

Outcome Measures

Primary Outcomes (1)

• Assessment of residual chronic pain and its functional interference at the time of the study.

  Chronic residual pain and its functional interference will be assessed using the Spanish version of the Brief Pain Inventory-Short Form (BPI-SF). This multidimensional self-administered questionnaire explores pain intensity using four items: maximum, minimum, average and current pain, on a scale of 0-10. The degree of interference of pain in daily life is assessed using seven items: mood, activity, work, relationships, sleep, enjoyment of life, and walking, on a scale of 0-10. An average score is calculated for each dimension (intensity and interference). This instrument has shown excellent reliability and validity

  Screening visit

Secondary Outcomes (3)

• Assessment of catastrophising at the time of the study.

  Screening visit

• Assessment of perceived self-efficacy for managing chronic pain at the time of the study.

  Screening visit

• Assessment of body image perception at the time of the study.

  Screening visit

Other Outcomes (5)

• Assessment of the sociodemographic variable age at the time of the study.

  Screening visit

• Assessment of the sociodemographic variable educational level at the time of the study.

  Screening visit

• Assessment of the clinical variable time with prophylactic treatment with bispecific monoclonal antibodies at the time of the study.

  Screening visit

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with haemophilia who meet the selection criteria will be informed of the characteristics of the study and the objectives to be achieved. Subjects included in the study will be required to complete a workbook containing a series of questionnaires designed to assess chronic residual pain and pain catastrophising, perceived self-efficacy in relation to the disease and treatment, and body image and perception of visible disability in patients with haemophilia.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

Universidad de Oviedo

Oviedo, Principality of Asturias, 33006, Spain

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Chronic Pain

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad de Oviedo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

0034 985103386; cuestaruben@uniovi.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: July 30, 2025
• Primary Completion: October 3, 2025
• Study Completion: October 26, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)