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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02427074
• Other study ID #: 1180/09
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2014
• Est. completion date: August 30, 2019

Study information

• Verified date: February 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: August 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Idiopathic Trigeminal Neuralgia

• Refractory/Intolerable medical treatment

• Pain restricted to second or third trigeminal division

Exclusion Criteria:

• Secondary Trigeminal Neuralgia

• Pain restricted to the first trigeminal division

• Refuse to participate

• Unable to comprehend the questionnaires

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	HCFMSUP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief using numeric rating scale	Worst pain in the last 24h scale in the Brief Pain Inventory	6 months
Secondary	Changes in how the pain is perceived by the patient assessed by the Short-Form of the McGill Pain Questionnaire	Short-Form of the McGill Pain Questionnaire	6 months
Secondary	Changes in neuropathic pain quality assessed by Douleur Neuropatique 4	Douleur Neuropatique 4	6 months
Secondary	Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory	Brief Pain Inventory	6 months
Secondary	Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory	Neuropathic Pain Symptom Inventory	6 months
Secondary	Changes in quality of life assessed by World Health Organization Quality of Life - brief form	World Health Organization Quality of Life - brief form	6 months
Secondary	Both patient and investigator impression in the treatment assessed by Global Clinical Impression	Global Clinical Impression	6 months
Secondary	Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale	Pain Catastrophizing Scale	6 months
Secondary	Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression	Hospital Anxiety and Depression	6 months
Secondary	Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing	Quantitative Sensorial Testing	6 months
Secondary	Changes in olfactory threshold assessed by isopropanol solution	Olfactory Threshold using isopropanol solution	6 months
Secondary	Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions	Gustatory Threshold using sweet, sour, salty and bitter solutions	6 months
Secondary	Changes in salivary flow assessed using cotton weights	Evaluation of salivary flow using cotton weights	6 months
Secondary	Changes in olfactory discrimination assessed using Sniffin' Sticks	Using Sniffin' Sticks to evaluate olfactory discrimination	6 months