Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-04-18 @ 5:42 AM
Study NCT ID:
NCT03131466
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2017-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}], 'ancestors': [{'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-24', 'studyFirstSubmitDate': '2017-04-22', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective rate of Primary Trigeminal Neuralgia treatment', 'timeFrame': '1 year after operation', 'description': 'The Barrow Neurological Institute (BNI) pain intensity score will be used to assess pain degree. Pain relief degree will be evaluated as "excellent" (BNI pain score I-II), "good" (BNI pain score III), and "poor" (BNI pain score IV-V). The effective rate=excellent and good pain relief (BNI I - III)/total number of cases \\* 100%.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation', 'description': 'Patient satisfaction score (PSS) score will be used to evaluate patient satisfaction: 0 point indicates unsatisfactory, while 10 points indicates very satisfactory.'}, {'measure': 'Dosage of adjuvant antiepileptic drugs', 'timeFrame': '1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation'}, {'measure': 'Data regarding patients with a BNI of IV or V who switch to other treatments', 'timeFrame': '1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation'}, {'measure': 'Adverse events', 'timeFrame': '1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion', 'description': 'Data regarding intraoperative and postoperative adverse events.'}, {'measure': 'The postoperative response rate', 'timeFrame': '1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion', 'description': 'The Barrow Neurological Institute (BNI) pain intensity score will be used to assess pain degree. Pain relief degree will be evaluated as "excellent" (BNI pain score I-II), "good" (BNI pain score III), and "poor" (BNI pain score IV-V). The effective rate=excellent and good pain relief (BNI I - III)/total number of cases \\* 100%.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trigeminal Neuralgia', 'Pulsed Radiofrequency', 'Gasserian Ganglion'], 'conditions': ['Idiopathic Trigeminal Neuralgia']}, 'referencesModule': {'references': [{'pmid': '24077204', 'type': 'BACKGROUND', 'citation': 'Nader A, Kendall MC, De Oliveria GS, Chen JQ, Vanderby B, Rosenow JM, Bendok BR. Ultrasound-guided trigeminal nerve block via the pterygopalatine fossa: an effective treatment for trigeminal neuralgia and atypical facial pain. Pain Physician. 2013 Sep-Oct;16(5):E537-45.'}, {'pmid': '26000688', 'type': 'BACKGROUND', 'citation': 'Nader A, Bendok BR, Prine JJ, Kendall MC. Ultrasound-Guided Pulsed Radiofrequency Application via the Pterygopalatine Fossa: A Practical Approach to Treat Refractory Trigeminal Neuralgia. Pain Physician. 2015 May-Jun;18(3):E411-5.'}, {'pmid': '27676662', 'type': 'BACKGROUND', 'citation': 'Elsheikh NA, Amr YM. Calcitonin as an Additive to Local Anesthetic and Steroid Injection Using a Modified Coronoid Approach in Trigeminal Neuralgia. Pain Physician. 2016 Sep-Oct;19(7):457-64.'}, {'pmid': '20121355', 'type': 'BACKGROUND', 'citation': 'Tsou HK, Chao SC, Wang CJ, Chen HT, Shen CC, Lee HT, Tsuei YS. Percutaneous pulsed radiofrequency applied to the L-2 dorsal root ganglion for treatment of chronic low-back pain: 3-year experience. J Neurosurg Spine. 2010 Feb;12(2):190-6. doi: 10.3171/2009.9.SPINE08946.'}, {'pmid': '23433058', 'type': 'BACKGROUND', 'citation': 'Fang L, Ying S, Tao W, Lan M, Xiaotong Y, Nan J. 3D CT-guided pulsed radiofrequency treatment for trigeminal neuralgia. Pain Pract. 2014 Jan;14(1):16-21. doi: 10.1111/papr.12041. Epub 2013 Feb 21.'}, {'pmid': '23322665', 'type': 'BACKGROUND', 'citation': 'Luo F, Meng L, Wang T, Yu X, Shen Y, Ji N. Pulsed radiofrequency treatment for idiopathic trigeminal neuralgia: a retrospective analysis of the causes for ineffective pain relief. Eur J Pain. 2013 Sep;17(8):1189-92. doi: 10.1002/j.1532-2149.2012.00278.x. Epub 2013 Jan 16.'}, {'pmid': '24954016', 'type': 'BACKGROUND', 'citation': 'Fang L, Tao W, Jingjing L, Nan J. Comparison of High-voltage- with Standard-voltage Pulsed Radiofrequency of Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia. Pain Pract. 2015 Sep;15(7):595-603. doi: 10.1111/papr.12227. Epub 2014 Jun 23.'}, {'pmid': '28076964', 'type': 'BACKGROUND', 'citation': 'Maarbjerg S, Di Stefano G, Bendtsen L, Cruccu G. Trigeminal neuralgia - diagnosis and treatment. Cephalalgia. 2017 Jun;37(7):648-657. doi: 10.1177/0333102416687280. Epub 2017 Jan 11.'}, {'pmid': '37464283', 'type': 'DERIVED', 'citation': 'Jia Y, Cheng H, Shrestha N, Ren H, Zhao C, Feng K, Luo F. Effectiveness and safety of high-voltage pulsed radiofrequency to treat patients with primary trigeminal neuralgia: a multicenter, randomized, double-blind, controlled study. J Headache Pain. 2023 Jul 18;24(1):91. doi: 10.1186/s10194-023-01629-7.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to compare the effectiveness and safety of high-voltage Pulsed radiofrequency and nerve block for the treatment of primary Trigeminal Neuralgia patients with ineffective conservative treatment and explore better non-surgical treatment methods for Trigeminal Neuralgia patients.', 'detailedDescription': 'Trigeminal neuralgia (TN) is a paroxysmal, lightning-like, severe pain in the facial area innervated by trigeminal nerve. Patients who have failed to achieve benefits from drug treatment could try to undergo nerve block, a traditional conservative treatment. Pulsed radiofrequency (PRF) is a noninvasive pain intervention technique for the treatment of TN. However, its treatment effectiveness has rarely been reported and remains controversial among scholars. A recent single-center preliminary clinical study showed that high-voltage PRF had significant effectiveness in the treatment of TN. However, whether high-voltage PRF treatment can become an optional treatment for TN patients who have failed to achieve benefits from drug treatment still needs to be confirmed with standardized clinical studies by utilizing conservative nerve block treatment as a control. The study is designed to compare the effectiveness and safety of high-voltage PRF and nerve block for the treatment of primary TN patients with ineffective conservative treatment and explore better non-surgical treatment methods for TN patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.\n* 18-75 years old.\n* Response to drug treatment poorly or unable to tolerate the side effects of drugs.\n* A BNI pain intensity scale score of IV-V.\n* Supposed to undergo neurosurgical intervention according to Trigeminal Neuralgia treatment guidelines.\n* Agree to participate in this trial and have signed the informed consent.\n\nExclusion Criteria:\n\n* Abnormal routine blood, liver or kidney functions, abnormal blood biochemistry test, or coagulation disorders.\n* Abnormal electrocardiogram or chest X-ray results.\n* Severe cardiopulmonary dysfunction.\n* Infection at the puncture site.\n* History of mental illness, or history of narcotic drug abuse.\n* Allergy to local anesthetic drugs or steroids.\n* Cannot cooperate with the treatment.\n* History of invasive treatments, such as radiofrequency thermocoagulation, chemical ablation, balloon compression surgery, gamma knife treatment, peripheral denervation or microvascular decompression.'}, 'identificationModule': {'nctId': 'NCT03131466', 'briefTitle': 'High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Effectiveness and Safety of High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia', 'orgStudyIdInfo': {'id': 'KY2017-004-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRF Group', 'description': 'This group will undergo 42°C high-voltage pulsed radiofrequency treatment.', 'interventionNames': ['Device: High-voltage pulsed radiofrequency']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nerve Block Group', 'description': 'This group will undergo nerve block treatment with steroid and local anesthesia.', 'interventionNames': ['Drug: Nerve block']}], 'interventions': [{'name': 'High-voltage pulsed radiofrequency', 'type': 'DEVICE', 'description': 'The manual PRF mode of the pain treatment generator will be turned on, the upper temperature limit will be set at 42°C, the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the patient will be treated for 360 s. After the treatment, 1.4 ml of a mixture of 0.4 mL of normal saline and 1 mL of 1% plain lidocaine will be injected through the needle of the cannula, and before the needle being removed, 0.5 mL of normal saline will be injected.', 'armGroupLabels': ['PRF Group']}, {'name': 'Nerve block', 'type': 'DRUG', 'description': 'The radiofrequency generator will be set at the sensory stimulating mode, and the lowest frequency of 0.2 V will be used for 360s-sham PRF treatment, after which 1.4 mL of a mixture of 2 mg of dexamethasone sodium phosphate and 1 mL of 1% plain lidocaine will be slowly injected through the radiofrequency treatment cannula needle. Before the needle being removed, 0.5 mL of normal saline will be injected.', 'armGroupLabels': ['Nerve Block Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Ditan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Fang Luo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice director of Department of Anesthesiology and Pain Management', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}