Chronic Pain and Hemophilia

Chronic Pain Clinical Trial

— HEMODOL  

Official title:

Status of Chronic Pain in Patients With Hemophilia.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05202951
• Other study ID #: RNI 2021 LEBRETON 2
• Secondary ID: 2021-A01217-34
• Status: Not yet recruiting
• Start date: January 2022
• Est. completion date: June 2023

Study information

• Verified date: December 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: June 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Hemophilia
• Hemophilia A

Intervention

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

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of chronic pain disorders	Questionnaire "Brief Pain Inventory" (BPI) + History of chronic pain (= 3 months, Yes or No)	Once
Secondary	Impact of chronic pain in daily life	Specific questions + Western Ontario and McMaster University Osteoarthritis (WOMAC)	Once
Secondary	Analgesic consumption	Type and quantity of analgesic used for treating chronic pain	Once
Secondary	Anxiodepressive disorders	Hospital Anxiety and Depression scale (HADS)	Once
Secondary	Sleep disorders	MOS-Sleep scale (MOS-SS) questionnaire	Once
Secondary	Perceived injustice of chronic pain	Injustice Experience Questionnaire (IEQ)	Once