NCT02427074

Comparison Between Radiofrequency and Balloon Compression in the Treatment of Idiopathic Trigeminal Neuralgia

Comparative Study Between Radiofrequency and Balloon Compression of the Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Two percutaneous procedures used in the treatment of idiopathic trigeminal neuralgia are analysed. The effects on pain relief, alterations in cutaneous sensibility and olfactory and salivatory functions are analysed as well.

Detailed description

Patients diagnosed with idiopathic trigeminal neuralgia, refractory or intolerant to medical treatment, are randomly assigned (after signing a consent form), to receive one of two percutaneous procedures. The patients are evaluated a week before and a week, a month, two months, three months and six months after the surgery. The questionnaires (Short-Form of the McGill Pain Questionnaire - SF-MPQ, Douleur Neuropathique - DN4, Neuropathic Pain Symptom Inventory - NPSI, Brief Pain Inventory - BPI, Global Clinical Impression - GCI, Hospital Anxiety and Depression - HAD, Brief World Health Organization Quality of Life Questionnaire - WHOQOL-brief, Pain Catastrophizing Scale - PCS) and tests (Quantitative Sensory Testing - QST, olfactory threshold - OT - and discrimination - OD, taste threshold - TT, and salivatory quantification - SQ) are applied as follows: * Pre-op evaluation: SF-MPQ, DN4, BPI, NPSI, HAD, WHOQOL-brief, PCS, QST, OT, OD, TT, SQ. * First visit post-op: SF-MPQ, BPI, NPSI, GCI * Second visit post-op: SF-MPQ, BPI, NPSI, GCI * Third visit post-op: SF-MPQ, BPI, NPSI, GCI * Fourth visit post-op: SF-MPQ, DN4, BPI, NPSI, GCI, WHOQOL-brief, HAD, PCS, QST, OT, TT, SQ. * Fifth visit post-op: SF-MPQ, DN4, BPI, NPSI, GCI, WHOQOL-brief, HAD, PCS, QST, OT, OD, TT, SQ. Patients with pain recurrence are excluded after the last visit attended. An exploratory analysis is made with 30 patients for a proper sample size calculation during the study.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
PROCEDURE	Balloon Compression Rhizotomy	The balloon compression rhizotomy is performed in a percutaneous fashion where a Fogarty catheter is positioned in the gasserian ganglion and inflated with 0,7 milliliters of radiopaque dye during 120 seconds.
PROCEDURE	Radiofrequency Thermal Coagulation Rhizotomy	The gasserian ganglion is submitted to a controlled thermal coagulation with a electrode with 80 Celsius degrees of temperature during 60 seconds on the specific division.

Timeline

• Start date: 2014-02-01
• Primary completion: 2019-03-31
• Completion: 2019-08-30
• First posted: 2015-04-27
• Last updated: 2020-02-13

Locations

1 site across 1 country: Brazil