Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-27 @ 2:28 AM
Study NCT ID:
NCT06914193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esketamine Combined With PRF of DRG for Postherpetic Neuralgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}], 'ancestors': [{'id': 'D009437', 'term': 'Neuralgia'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 186}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-05', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary comparison is the difference between the means of the daily mean pain scores over the first 7 days, measured on an 11-point NRS', 'timeFrame': '7-day period', 'description': 'The Numeric Rating Scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain'}], 'secondaryOutcomes': [{'measure': 'average weekly NRS score', 'timeFrame': 'up to 12 weeks', 'description': 'Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain'}, {'measure': 'Averaged weekly analgesic consumption', 'timeFrame': 'up to 12 weeks', 'description': 'Averaged weekly consumption per analgesic of each participant for rescue analgesia'}, {'measure': 'the 12-item Short-Form Health Survey (SF-12) score', 'timeFrame': 'At the end of weeks1, 2, 4, 8, and 12 after treatment', 'description': 'Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status)'}, {'measure': 'the Pittsburgh Sleep Quality Index (PSQI) score', 'timeFrame': 'At the end of weeks 1,2, 4, 8, and 12 after treatment', 'description': 'Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality).'}, {'measure': 'the Patient Global Impression of Change scale (PGIC)', 'timeFrame': 'At the end of weeks 1,2 4, 8, and 12 after treatment', 'description': 'The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC.'}, {'measure': 'The Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'At the end of weeks 1, 2, 4, 8, and 12 after treatment', 'description': 'It consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression.'}, {'measure': 'Safety assessments', 'timeFrame': 'Conducted on Day 0, Day 1, Day 3, and at the end of weeks 1, 2, 4, 8, and 12 after treatment', 'description': 'intraoperative complications, PRF-related complications, Eskatamine-related complications, Pregabaline-related complications'}, {'measure': 'success rate', 'timeFrame': 'At the end of weeks 1, 2, 4, 8, and 12 after treatment', 'description': 'The success rate is defined as more than a 50% reduction in NRS-11 score.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postherpetic Neuralgia', 'Esketamine'], 'conditions': ['Postherpetic Neuralgia']}, 'descriptionModule': {'briefSummary': "This trial's primary objective is to compare the analgesic efficacy of esketamine in combination with pulsed radiofrequency (PRF) of dorsal root ganglion(DRG) against that of PRF monotherapy in patients with postherpetic neuralgia(PHN).", 'detailedDescription': 'This study aims to determine whether the addition of esketamine to the PRF of DRG regimen can relieve pain in PHN patients. By doing so, the research endeavors to identify a rapid, effective, and safe treatment approach for refractory PHN patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages more than 18 years;\n2. Pain persisting for over three months following the onset of the herpes zoster skin rash;\n3. Lesions located in in the unilateral cervical, thoracic, and lumbosacral segments;\n4. Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)； Planned to perform CT-guided PRF treatment of the Dorsal root ganglion（DRG）\n\nExclusion Criteria:\n\n1. Obstructive sleep apnoea syndrome;\n2. Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of DRG.\n3. A history of systemic immune diseases, organ transplantation, or cancers;\n4. A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;\n5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;\n6. Comorbid hyperthyroidism or phaeochromocytoma;\n7. Recent history of drug abuse;\n8. Having contraindications to esketamine;\n9. Communication difficulties.\n10. Women who are preparing for pregnancy, in the pregnancy or lactation period.'}, 'identificationModule': {'nctId': 'NCT06914193', 'briefTitle': 'Esketamine Combined With PRF of DRG for Postherpetic Neuralgia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Intravenous Infusion of Esketamine in Combination With Pulsed Radiofrequency of Dorsal Root Ganglion for Postherpetic Neuralgia', 'orgStudyIdInfo': {'id': 'KY-2024-332-02-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'esketamine group', 'description': 'esketamine+PRF group', 'interventionNames': ['Drug: esketamine+PRF treatment group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'PRF group', 'interventionNames': ['Drug: PRF treatment group']}], 'interventions': [{'name': 'esketamine+PRF treatment group', 'type': 'DRUG', 'otherNames': ['esketamine+PRF treatment+pregabalin'], 'description': 'In the esketamine group, in addition to receiving PRF treatment+pregabalin, patients will also undergo a single intravenous infusion of esketamine.', 'armGroupLabels': ['esketamine group']}, {'name': 'PRF treatment group', 'type': 'DRUG', 'otherNames': ['PRF treatment+pregabalin'], 'description': "In the control group, patients will receive PRF treatment. PRF will be performed on DRG by an designated physician in each participating center. The patients will be treated with PRF (PMG-230, Baylis Medical Inc.) using a 21-gauge sterilized radiofrequency needle (a 10-cm trocar with a 5-mm active tip, PMF-21-100-5, Baylis Medical Inc.), which will be carefully inserted until the needle tip reached the upper edge of the intervertebral foramen under the guidance of three-dimensional (3D) CT. PRF treatment (PMG-230, Baylis Medical Inc.) targeting to DRG will be applied for 900 seconds. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. Regarding pregabalin, the dosage is titrated based on patients'pain intensity and tolerance. This process fully accounts for individual patient differences to optimize treatment outcomes.", 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fang Luo', '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': 'Beijing Xiaotangshan Hospital', 'class': 'OTHER'}, {'name': 'The First Hospital of Fangshan District,Beijing', 'class': 'OTHER'}, {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, {'name': "Hengshui People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Day surgery and Pain Management', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}