drugset / Trial / NCT03131466
High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
Completed
134 enrolled
Beijing Tiantan Hospital
Beijing Ditan Hospital · collabBeijing Friendship Hospital · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2017-04-28
- Primary completion
- 2020-09-03
- Completion
- 2021-09-03
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 2 mg | Other |
| Comparator | Lidocaine | Other / unclassified | 1 ml | Other |
| Comparator | Lidocaine | Other / unclassified | 1 % | Other |