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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Beijing Tiantan Hospital

Current Primary Outcome: 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%.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Beijing Tiantan Hospital

Dates:
Date Received: April 22, 2017
Date Started: May 1, 2017
Date Completion: December 31, 2019
Last Updated: April 26, 2017
Last Verified: April 2017