Chronic Pain and Hemophilia

Recruiting

• Conditions: Hemophilia; Chronic Pain
• Interventions: Other: questionnaires

• Registration Number: NCT05202951
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

This first French assessment of chronic pain in patients with haemophilia will permit to improve and generate new data about chronic pain related to haemophilia, associated-comorbidities, sociodemographic characteristics and analgesic treatments used.

These data will be retrieved using several questionnaires in the RedCap web plateform (eCRF).

The study will include 6 investigator centres and a minimum of 350 patients during 12 months.

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Study Start: 2022-02-28
• Status Verified: 2024-06
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-02-28
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with hemophilia	questionnaires	all adult patients follow-upin Hospital for hemophilia

Primary Outcome Measures

Name	Time	Method
Prevalence of chronic pain disorders	through study completion, an average of 1 year	Questionnaire "Brief Pain Inventory" (BPI) + History of chronic pain (≥ 3 months, Yes or No)

Secondary Outcome Measures

Name	Time	Method
Impact of chronic pain in daily life	through study completion, an average of 1 year	Specific questions + Western Ontario and McMaster University Osteoarthritis (WOMAC)
Analgesic consumption	through study completion, an average of 1 year	Type and quantity of analgesic used for treating chronic pain
Anxiodepressive disorders	through study completion, an average of 1 year	Hospital Anxiety and Depression scale (HADS): this questionnaire makes it possible to detect anxiety and depressive disorders. It has 14 items sided from 0 to 3. Seven questions relate to anxiety and the 7 to the depressive dimension, thus obtaining two scores of up to 21.
Sleep disorders	through study completion, an average of 1 year	MOS-Sleep scale (MOS-SS) questionnaire: this questionnaire deals with daytime sleepiness. It also looks at a person's ability to stay and fall asleep, how often they sleep and for how long, whether the sleep they get is adequate for their lifestyle, and any existing breathing factors that can affect sleep like sleep apnea.
Perceived injustice of chronic pain	through study completion, an average of 1 year	Injustice Experience Questionnaire (IEQ)

Trial Locations

Locations (10)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Centre Hospitalier Universitaire de Caen Normandie; 🇫🇷 Caen, France

CH Métropole Savoie; 🇫🇷 Chambéry, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de LILLE; 🇫🇷 Lille, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Centre Hospitalier Universitaire de Nantes; 🇫🇷 Nantes, France

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France

CHU de TOULOUSE; 🇫🇷 Toulouse, France