Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-01 @ 5:30 AM
Study NCT ID:
NCT05196503
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2021-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity of Residual Post-surgical Neuropathic Pain After a Surgery for Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2022-01-18', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the effectiveness of periricular intraoperative application of Platelet- and Fibrin-enriched plasma (PRF) on the intensity of residual neuropathic pain postoperatively with primary herniated disc surgery.', 'timeFrame': '6 months', 'description': 'Average intensity, over 24 hours, of a sequellar radicular neuropathic painy an EVA and affirmed by a DN4 score greater than or equal to 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuropathic pain', 'Chronic postsurgical pain prevention', 'Intraoperative platelet rich fibrin', 'Disc herniation surgery'], 'conditions': ['Neuropathic Pain', 'Chronic Postsurgical Pain']}, 'referencesModule': {'references': [{'pmid': '37337269', 'type': 'DERIVED', 'citation': 'Todeschi J, Dannhoff G, Coca AH, Timbolschi DI, Proust F, Lefebvre F, Lelievre V, Poisbeau P, Vallat L, Salvat E, Bohren Y. Effect of an intraoperative periradicular application of platelet-rich fibrin (PRF) on residual post-surgical neuropathic pain after disc herniation surgery: study protocol for NeuroPRF, a randomized controlled trial. Trials. 2023 Jun 19;24(1):418. doi: 10.1186/s13063-023-07420-y.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of post-surgical lumbar neuropathic radiculopathy is approximately 30%. Poor response to the treatments recommended for neuropathic pain, namely antidepressants and/or gabapentinoids, requires the development of new techniques to prevent this chronic pain. Certain well-tolerated techniques, such as the administration of plasma enriched with platelets and fibrin (PRF), are increasingly used in regenerative medicine for their anti-inflammatory and analgesic properties. Thus, a periradicular intraoperative application of PRF may have an analgesic effect on the intensity of residual postsurgical neuropathic pain after disc herniation surgery.', 'detailedDescription': 'A superiority study, phase III, prospective, single-center, randomized in parallel groups and conducted in a single-blind manner, with evaluation by a blind outcome assessor. Patients will be randomized to one of two treatment groups: Experimental group (surgery and periradicular administration of PRF) or Control group (reference treatment, surgery alone).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient, male or female, \\>18 years old at the time of signing informed consent;\n* Patient for whom a diagnosis of radiculopathy on lumbar disc herniation has been made, and for whom surgery has been scheduled in the Neurosurgery department;\n* Patient affiliated to a social security health insurance scheme;\n* Patient able to understand the objectives and risks of research and to give informed, dated and signed consent;\n* Patient having been informed of the results of the prior medical examination;\n* Women of childbearing age provided that a negative blood pregnancy test is recorded at the inclusion visit and effective contraception used throughout the study.\n\nExclusion criteria:\n\n* Patient with a history of lumbar spinal surgery (multiple herniated discs, herniated disc other than lumbar);\n* Patient with HIV, active cancer, HBV, HCV (verified by interview);\n* Patient on long-term systemic corticosteroid therapy;\n* Patient with an ASA score \\> 3 during the consultation with the anesthesiologist;\n* Inability to give the patient informed information (patient in an emergency or life-threatening situation, difficulties in understanding);\n* Patient in exclusion period (determined by a previous or ongoing study);\n* Subject under safeguard of justice;\n* Subject under curatorship;\n* Pregnancy;\n* Breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05196503', 'acronym': 'NeuroPRF', 'briefTitle': 'Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity of Residual Post-surgical Neuropathic Pain After a Surgery for Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery', 'orgStudyIdInfo': {'id': '8363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental group', 'description': 'Surgery for disc herniation and intraoperative periradicular administration of PRF', 'interventionNames': ['Biological: Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Surgery for disc herniation alone (i.e. reference treatment).', 'interventionNames': ['Biological: Treatment']}], 'interventions': [{'name': 'Treatment', 'type': 'BIOLOGICAL', 'description': 'Experimental product: product derived from autologous blood, obtained after centrifugation.\n\nTreatment modalities: intraoperative periradicular administration of autologous PRF.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'state': 'Bas-Rhin', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric SALVAT', 'role': 'CONTACT', 'email': 'eric.salvat@chru-strasbourg.fr', 'phone': '+33 3 88 12 85 02'}, {'name': 'Daniel TIMBOLSCHI IONUT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lauriane JOGANAH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'André MULLER', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yohann BOHREN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François PROUST', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hugo Andres COCA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Les Hôpitaux Universitaires', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Erci SALVAT', 'role': 'CONTACT', 'email': 'eric.salvat@chru-strasbourg.fr', 'phone': '+33 3 88 12 85 02'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}