Chronic Pain and Hemophilia

NCT05202951 | Active Not Recruiting

• 2 other identifiers: RNI 2021 LEBRETON 22021-A01217-34
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 10

Brief Summary

Hemophilia (A and B) are X-linked hereditary bleeding disorders whose severity depends on the level of coagulation factor (FVIII or FIX respectively). Bleeding is mainly from joints (hemarthrosis) and muscles (hematoma). Nowadays, treatment is based on preventive or curative intravenous infusion of coagulation factor concentrates. Despite these treatments, there is joint deterioration that can be responsible for hemophilic arthropathy and chronic pain. This pain may be related to excess nociception during acute bleeding, but it may also be neuropathic. There are only a few studies that have looked at pain in hemophilia, but it is accepted that the vast majority of patients (especially those with severe forms) suffer from chronic pain. Because patients have become accustomed to this pain and physicians are still not very aware of how to assess it, this pain is not treated effectively. In order to better manage pain in hemophilia, it is therefore necessary to characterize their pain and to know the nociceptive or neuropathic component. The aim of our study is therefore to study the prevalence, the nociceptive or neuropathic profile, the chronic aspect of pain and the main locations of pain in hemophilia. In addition to raising the awareness of physicians in the centers about pain management using specific questionnaires, this survey will help to better define chronic pain in hemophilia of all severities.

Conditions

Chronic Pain; Hemophilia

Keywords

Chronic Pain; Hemophilia

Outcome Measures

Primary Outcomes (1)

• Prevalence of chronic pain disorders

  Questionnaire "Brief Pain Inventory" (BPI) + History of chronic pain (≥ 3 months, Yes or No)

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Impact of chronic pain in daily life

  through study completion, an average of 1 year

• Analgesic consumption

  through study completion, an average of 1 year

• Anxiodepressive disorders

  through study completion, an average of 1 year

• Sleep disorders

  through study completion, an average of 1 year

• Perceived injustice of chronic pain

  through study completion, an average of 1 year

Study Arms (1)

Patients with hemophilia

all adult patients follow-upin Hospital for hemophilia

Other: questionnaires

Interventions

questionnaires OTHER

Electronic case report form integrating questionnaires on chronic pain related to haemophilia, associated-comorbidities, sociodemographic characteristics and analgesic treatments used.

Also known as: RedCap web platform

Patients with hemophilia

Eligibility Criteria

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

Study Population

Patients with hemophilia

You may qualify if:

• Patient with haemophilia of any severity,
• Carrier female with low levels haemophilia (\< 40%),
• ≥ 18 years of age and capable of giving informed consent to participate in research.

You may not qualify if:

• Patient's refusal to participate in the survey,
• Patient does not understand enough French (written and spoken) to complete the survey,
• Patient unable to complete the survey for logistical reasons (lack of internet access),
• Patient under protective measures (guardianship),
• Patients with known addictive comorbidities and/or cognitive disorders.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (10)

CHU de Bordeaux

Bordeaux, France

Location

Centre Hospitalier Universitaire de Caen Normandie

Caen, France

Location

CH Métropole Savoie

Chambéry, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU de Grenoble

Grenoble, France

Location

CHU de LILLE

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, France

Location

CHU de Saint-Etienne

Saint-Etienne, France

Location

CHU de TOULOUSE

Toulouse, France

Location

MeSH Terms

Conditions

Chronic Pain; Hemophilia A

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Aurélien LEBRETON

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: February 28, 2022
• Primary Completion: December 18, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

FR (10)