High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
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|ClinicalTrials.gov Identifier: NCT03131466|
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Trigeminal Neuralgia||Device: High-voltage pulsed radiofrequency Drug: Nerve block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effectiveness and Safety of High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia|
|Actual Study Start Date :||April 28, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: PRF Group
This group will undergo 42°C high-voltage pulsed radiofrequency treatment.
Device: High-voltage pulsed radiofrequency
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.
Active Comparator: Nerve Block Group
This group will undergo nerve block treatment with steroid and local anesthesia.
Drug: Nerve block
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.
- Effective rate of Primary Trigeminal Neuralgia treatment [ Time Frame: 1 year after operation ]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%.
- Patient satisfaction [ Time Frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year after operation ]Patient satisfaction score (PSS) score will be used to evaluate patient satisfaction: 0 point indicates unsatisfactory, while 10 points indicates very satisfactory.
- Dosage of adjuvant antiepileptic drugs [ Time Frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year after operation ]
- Data regarding patients with a BNI of IV or V who switch to other treatments [ Time Frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year after operation ]
- Adverse events [ Time Frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year after opeartion ]Data regarding intraoperative and postoperative adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131466
|Contact: Fang Luo, M.D.||+86 email@example.com|
|Beijing Ditan Hospital||Recruiting|
|Beijing, Beijing, China, 100015|
|Contact: Hao Cheng, M.D. +86 13801312117 firstname.lastname@example.org|
|Principal Investigator: Hao Cheng, M.D.|
|Beijing Friendship Hospital||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Yanping Li, M.D. +86 13701197818 email@example.com|
|Principal Investigator: Yanping Li, M.D.|
|Beijing Tiantan Hospital||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Fang Luo, M.D. +86 13611326978 firstname.lastname@example.org|
|Principal Investigator: Fang Luo, M.D.|
|Principal Investigator:||Fang Luo, M.D.||Beijing Tiantan Hospital|