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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01217-34 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with hemophilia | all adult patients follow-upin Hospital for hemophilia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires | Other | Electronic case report form integrating questionnaires on chronic pain related to haemophilia, associated-comorbidities, sociodemographic characteristics and analgesic treatments used. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of chronic pain in daily life | Specific questions + Western Ontario and McMaster University Osteoarthritis (WOMAC) | through study completion, an average of 1 year |
| Analgesic consumption |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with hemophilia
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| Name | Affiliation | Role |
|---|---|---|
| Aurélien LEBRETON | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France | ||||
| Centre Hospitalier Universitaire de Caen Normandie |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
Type and quantity of analgesic used for treating chronic pain
| through study completion, an average of 1 year |
| Anxiodepressive disorders | 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. | through study completion, an average of 1 year |
| Sleep disorders | 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. | through study completion, an average of 1 year |
| Perceived injustice of chronic pain | Injustice Experience Questionnaire (IEQ) | through study completion, an average of 1 year |
| Caen |
| France |
| CH Métropole Savoie | Chambéry | France |
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63000 | 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-Etienne | France |
| CHU de TOULOUSE | Toulouse | France |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |