Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT06461312
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060545', 'term': 'Pudendal Neuralgia'}], 'ancestors': [{'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2024-06-06', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Global Impression of Change', 'timeFrame': '1month', 'description': '0 -100%#0=no change,100%= complete relief of pain symptoms.'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': '2months', 'description': '0 -100%#0=no change,100%= complete relief of pain symptoms.'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': '3months', 'description': '0 -100%#0=no change,100%= complete relief of pain symptoms.'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': '6months', 'description': '0 -100%#0=no change,100%= complete relief of pain symptoms.'}], 'secondaryOutcomes': [{'measure': 'Numeric Rating Scale', 'timeFrame': '1month', 'description': '0-10#0 =no pain, 10 = the most severe pain.'}, {'measure': 'Numeric Rating Scale', 'timeFrame': '2months', 'description': '0-10#0 =no pain, 10 = the most severe pain.'}, {'measure': 'Numeric Rating Scale', 'timeFrame': '3months', 'description': '0-10#0 =no pain, 10 = the most severe pain.'}, {'measure': 'Numeric Rating Scale', 'timeFrame': '6months', 'description': '0-10#0 =no pain, 10 = the most severe pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pudendal Neuralgia', 'Pulsed Radiofrequency']}, 'descriptionModule': {'briefSummary': 'Patients with pudendal neuralgia suffer from long-term pain, which severely affects their quality of life. Due to unclear etiology, there is a lack of specific treatment methods. The aim of this study is to evaluate the efficacy of combined pulsed radiofrequency with ganglion impar block therapy helps evaluate the effectiveness of this treatment method for pudendal neuralgia, comparing it with traditional treatments or single interventions, and providing guidance for clinical practice.', 'detailedDescription': 'We plan to enroll patients with pudendal neuralgia .Pre-treatment, we collected data including pain assessment, anxiety, depression, catastrophizing, and pain sensitivity scales. Treatment involved ultrasound-guided pudendal nerve pulsed radiofrequency and X-ray-guided ganglion impar block. The Patient Global Impression of Change (PGIC) and Numeric Rating Scale (NRS) were used as the main observation indicators to evaluate the treatment effect at 1, 2, 3, and 6 months postoperatively, followed by correlation analysis with the scores of relevant scales.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 80 years old;\n2. Diagnosis of pudendal neuralgia meets the Nantes criteria. essential criteria include the following：1）Pain in the territory of the pudendal nerve；2） Pain is predominantly experienced while sitting；3) The pain does not wake the patient at night；4）Pain with no objective sensory impairment；5）Pain relieved by diagnostic pudendal nerve block；\n3. Received conservative treatment for more than 3 months, and either had poor response to conservative treatment or intolerable medication side effects.\n4. Capable of signing informed consent form.\n\nExclusion Criteria:\n\n1. Pain caused by pelvic malignant diseases or autoimmune diseases;\n2. Pain caused by pelvic surgery;\n3. Taking anticoagulant drugs or having abnormal coagulation function;\n4. Pregnancy;\n5. Systemic infectious diseases;\n6. Inability to complete scale assessments.'}, 'identificationModule': {'nctId': 'NCT06461312', 'acronym': 'PRF', 'briefTitle': 'Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Combined Pulsed Radiofrequency of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia', 'orgStudyIdInfo': {'id': '2024PHB200-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'enrolled patients', 'description': 'Enrolled patients underwent pulsed radiofrequency of the pudendal nerve combined with ganglion impar block after pudendal nerve diagnostic block', 'interventionNames': ['Procedure: Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block']}], 'interventions': [{'name': 'Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block', 'type': 'PROCEDURE', 'description': 'Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block', 'armGroupLabels': ['enrolled patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yiming Liu, MD', 'role': 'CONTACT', 'email': 'enayanyan0227@126.com', 'phone': '88325206'}], 'facility': "People's Hospital of Peking University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yifan Yang, MD', 'role': 'CONTACT', 'email': 'enayanyan0227@126.com', 'phone': '18701545165'}], 'overallOfficials': [{'name': 'Yiming Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of department of Anesthesiology and Pain medicine', 'investigatorFullName': 'Yi Feng, MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}