Clinical trial NCT05202951: Chronic Pain and Hemophilia
Official title: Status of Chronic Pain in Patients With Hemophilia.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Hemophilia
Keywords: Chronic Pain
Hemophilia
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hemophilia

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of chronic pain disorders
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Impact of chronic pain in daily life
timeFrame: through study completion, an average of 1 year
measure: Analgesic consumption
timeFrame: through study completion, an average of 1 year
measure: Anxiodepressive disorders
timeFrame: through study completion, an average of 1 year
measure: Sleep disorders
timeFrame: through study completion, an average of 1 year
measure: Perceived injustice of chronic pain
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen Normandie
city: Chambéry
country: France
facility: CH Métropole Savoie
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHU de LILLE
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Toulouse
country: France
facility: CHU de TOULOUSE
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Aurélien LEBRETON
role: PRINCIPAL_INVESTIGATOR
References: