High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia

Idiopathic Trigeminal Neuralgia Clinical Trial

Official title:

Effectiveness and Safety of High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131466
• Other study ID #: KY2017-004-01
• Status: Completed
• Phase: N/A
• Start date: April 28, 2017
• Est. completion date: September 3, 2021

Study information

• Verified date: October 2021
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: September 3, 2021
• Est. primary completion date: September 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.

• 18-75 years old.

• Response to drug treatment poorly or unable to tolerate the side effects of drugs.

• A BNI pain intensity scale score of IV-V.

• Supposed to undergo neurosurgical intervention according to Trigeminal Neuralgia treatment guidelines.

• Agree to participate in this trial and have signed the informed consent.

Exclusion Criteria:

• Abnormal routine blood, liver or kidney functions, abnormal blood biochemistry test, or coagulation disorders.

• Abnormal electrocardiogram or chest X-ray results.

• Severe cardiopulmonary dysfunction.

• Infection at the puncture site.

• History of mental illness, or history of narcotic drug abuse.

• Allergy to local anesthetic drugs or steroids.

• Cannot cooperate with the treatment.

• History of invasive treatments, such as radiofrequency thermocoagulation, chemical ablation, balloon compression surgery, gamma knife treatment, peripheral denervation or microvascular decompression.

Related Conditions & MeSH terms

• Ganglion Cysts
• Idiopathic Trigeminal Neuralgia
• Neuralgia
• Trigeminal Neuralgia

Intervention

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.

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.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Ditan Hospital, Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective rate of Primary Trigeminal Neuralgia treatment	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%.	1 year after operation
Secondary	Patient satisfaction	Patient satisfaction score (PSS) score will be used to evaluate patient satisfaction: 0 point indicates unsatisfactory, while 10 points indicates very satisfactory.	1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
Secondary	Dosage of adjuvant antiepileptic drugs		1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
Secondary	Data regarding patients with a BNI of IV or V who switch to other treatments		1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
Secondary	Adverse events	Data regarding intraoperative and postoperative adverse events.	1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion
Secondary	The postoperative response rate	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%.	1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion