Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT05202951
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2022-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Pain and Hemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of chronic pain disorders', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Questionnaire "Brief Pain Inventory" (BPI) + History of chronic pain (≥ 3 months, Yes or No)'}], 'secondaryOutcomes': [{'measure': 'Impact of chronic pain in daily life', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Specific questions + Western Ontario and McMaster University Osteoarthritis (WOMAC)'}, {'measure': 'Analgesic consumption', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Type and quantity of analgesic used for treating chronic pain'}, {'measure': 'Anxiodepressive disorders', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Sleep disorders', 'timeFrame': 'through study completion, an average of 1 year', 'description': "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."}, {'measure': 'Perceived injustice of chronic pain', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Injustice Experience Questionnaire (IEQ)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Pain', 'Hemophilia'], 'conditions': ['Chronic Pain', 'Hemophilia']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.', 'detailedDescription': '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.\n\nThese data will be retrieved using several questionnaires in the RedCap web plateform (eCRF).\n\nThe study will include 6 investigator centres and a minimum of 350 patients during 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hemophilia', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with haemophilia of any severity,\n* Carrier female with low levels haemophilia (\\< 40%),\n* ≥ 18 years of age and capable of giving informed consent to participate in research.\n\nExclusion Criteria:\n\n* Patient's refusal to participate in the survey,\n* Patient does not understand enough French (written and spoken) to complete the survey,\n* Patient unable to complete the survey for logistical reasons (lack of internet access),\n* Patient under protective measures (guardianship),\n* Patients with known addictive comorbidities and/or cognitive disorders."}, 'identificationModule': {'nctId': 'NCT05202951', 'acronym': 'HEMODOL', 'briefTitle': 'Chronic Pain and Hemophilia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Status of Chronic Pain in Patients With Hemophilia.', 'orgStudyIdInfo': {'id': 'RNI 2021 LEBRETON 2'}, 'secondaryIdInfos': [{'id': '2021-A01217-34', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with hemophilia', 'description': 'all adult patients follow-upin Hospital for hemophilia', 'interventionNames': ['Other: questionnaires']}], 'interventions': [{'name': 'questionnaires', 'type': 'OTHER', 'otherNames': ['RedCap web platform'], 'description': 'Electronic case report form integrating questionnaires on chronic pain related to haemophilia, associated-comorbidities, sociodemographic characteristics and analgesic treatments used.', 'armGroupLabels': ['Patients with hemophilia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT'}, {'name': 'Sabine CASTET, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT'}, {'name': 'Yohann REPESSE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Benjamin GILLET, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jérémy PEROTTET, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Caen Normandie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Chambéry', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT'}, {'name': 'Valérie GAY, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pascal MEYER, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Romain JAILLER, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CH Métropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '+33473754963'}, {'name': 'Aurélien LEBRETON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT'}, {'name': 'Claire BARRO, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raphaël MARLU, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT'}, {'name': 'Mélanie DANIEL, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sophie SUSEN, Pr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antoine RAUCH, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bénédicte WIBAUT-PEGNEAUX, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de LILLE', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT'}, {'name': 'Anne LIENHART, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yesim DARGAUD, Pr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stéphanie DESAGE, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT'}, {'name': 'Marc TROSSAERT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marc FOUASSIER, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicolas DRILLAUD, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antoine BABUTY, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT'}, {'name': 'Brigitte TARDY, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT'}, {'name': 'Caroline OUDOT CHALLARD, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marie-Léa PIEL-JULIAN, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de TOULOUSE', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '+33473754963'}], 'overallOfficials': [{'name': 'Aurélien LEBRETON', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}