Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-29 @ 2:38 PM
Study NCT ID:
NCT06931457
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet Rich Plasma to Treat Idiopathic Glossopharyngeal Neuralgia (GPN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020435', 'term': 'Glossopharyngeal Nerve Diseases'}], 'ancestors': [{'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 121}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric rating scale (NRS) score', 'timeFrame': '1day, 3days, 1week, 2weeks, 1month, 3months, 6months, and 1year following the procedure', 'description': 'Numeric rating scale (NRS) score during resting was used to evaluate pain intensity before and after PRF treatment (0=no pain, 10=intolerable pain)'}], 'secondaryOutcomes': [{'measure': 'Barrow Neurological Institute pain scale(BNI score)', 'timeFrame': '1day, 3days, 1week, 2weeks, 1month, 3months, 6months, and 1year following the procedure', 'description': 'BNI score during resting was used to evaluate pain relief'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glossopharyngeal Neuralgia', 'Pulsed Radiofrequency', 'Platelet Rich Plasma']}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of the application of PRF combined PRP to the for the treatment of GPN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Suitable participants will be screened at the pain management center of each hospital to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age \\>18 years;\n2. diagnosed with idiopathic GPN according to the third International Classification of Headache Disorders (ICHD) classification;\n3. patients who failed pharmacotherapy or intolerable side effects of medication;\n4. undergoing PRF for GPN;\n5. at least 1 month of follow-up recordings.\n\nExclusion Criteria:\n\n1. Patients with bilateral GPN;\n2. Abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiography or chest radiography;\n3. Infection at the puncture site;\n4. Previous mental illness;\n5. Previous history of narcotic drug abuse;\n6. Prior anticoagulant or antiplatelet therapy;\n7. An implantable pulse generator;\n8. Current pregnancy or breast feeding.\n9. Patients with incomplete medical records (lack of baseline data or postoperative follow-up data).'}, 'identificationModule': {'nctId': 'NCT06931457', 'briefTitle': 'Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet Rich Plasma to Treat Idiopathic Glossopharyngeal Neuralgia (GPN)', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Platelet Rich Plasma, to the Treatment of Idiopathic Glossopharyngeal Neuralgia (GPN): A Study Protocol for a Multi-Center, Prospective, Open-Label, Propensity Score Match Cohort Study', 'orgStudyIdInfo': {'id': 'KY 2023-263-03-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PRF group', 'description': 'Motor stimulation at 2 Hz, 1.0V will be performed and the negative results indicated that no muscle contraction will be generated. Afterwards, PRF treatment will be performed for 360 seconds. The parameters of PRF application were initiated at the voltage of 45 V, the temperature of 42°C, the pulse rate of 2Hz at the rate of 20 milliseconds.\n\nThe pulse treatment generator will be set to the automatic pulsed radiofrequency mode, with a temperature of 42°C, pulse frequency of 2Hz, pulse width of 20ms and treatment duration of 360s.'}, {'label': 'PRF+PRP group', 'description': "Motor stimulation at 2 Hz, 1.0V will be performed and the negative results indicated that no muscle contraction will be generated. Afterwards, PRF treatment will be performed for 360 seconds. The parameters of PRF application were initiated at the voltage of 45 V, the temperature of 42°C, the pulse rate of 2Hz at the rate of 20 milliseconds.\n\nThe pulse treatment generator will be set to the automatic pulsed radiofrequency mode, with a temperature of 42°C, pulse frequency of 2Hz, pulse width of 20ms and treatment duration of 360s. PRF group will only receive PRF treatment, PRF combined with PRP group, after removing the radiofrequency electrode, 2 ml of LP-PRP mixture will be injected slowly. Additional analgesics will be administered for participants' comfort during and after the procedure. If the patients were not satisfied with the outcome after one month, other treatment options will be available."}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fang Luo, M.D.', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '+86 13611326978'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not yet decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Pain Management', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}