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

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.

Study Overview

• Status: Terminated
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Procedure: Balloon Compression Rhizotomy; Procedure: Radiofrequency Thermal Coagulation Rhizotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403000
      • HCFMSUP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Balloon Compression Rhizotomy; Patients that are submitted to Balloon Compression Rhizotomy	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.
Active Comparator: Radiofrequency Thermal Coagulation Rhizotomy; Patients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief using numeric rating scale	Worst pain in the last 24h scale in the Brief Pain Inventory	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in neuropathic pain quality assessed by Douleur Neuropatique 4	Douleur Neuropatique 4	6 months
Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory	Brief Pain Inventory	6 months
Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory	Neuropathic Pain Symptom Inventory	6 months
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
Both patient and investigator impression in the treatment assessed by Global Clinical Impression	Global Clinical Impression	6 months
Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale	Pain Catastrophizing Scale	6 months
Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression	Hospital Anxiety and Depression	6 months
Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing	Quantitative Sensorial Testing	6 months
Changes in olfactory threshold assessed by isopropanol solution	Olfactory Threshold using isopropanol solution	6 months
Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions	Gustatory Threshold using sweet, sour, salty and bitter solutions	6 months
Changes in salivary flow assessed using cotton weights	Evaluation of salivary flow using cotton weights	6 months
Changes in olfactory discrimination assessed using Sniffin' Sticks	Using Sniffin' Sticks to evaluate olfactory discrimination	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Daniel Ciampi, MD, PhD, HCFMSUP

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: April 18, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: 1180/09