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

Primary Purpose

Trigeminal Neuralgia

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Balloon Compression Rhizotomy
Radiofrequency Thermal Coagulation Rhizotomy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HCFMSUP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Balloon Compression Rhizotomy

Radiofrequency Thermal Coagulation Rhizotomy

Arm Description

Patients that are submitted to Balloon Compression Rhizotomy

Patients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy

Outcomes

Primary Outcome Measures

Pain relief using numeric rating scale
Worst pain in the last 24h scale in the Brief Pain Inventory

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2015
Last Updated
February 11, 2020
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02427074
Brief Title
Comparison Between Radiofrequency and Balloon Compression in the Treatment of Idiopathic Trigeminal Neuralgia
Official Title
Comparative Study Between Radiofrequency and Balloon Compression of the Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Study halted due to futility
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon Compression Rhizotomy
Arm Type
Active Comparator
Arm Description
Patients that are submitted to Balloon Compression Rhizotomy
Arm Title
Radiofrequency Thermal Coagulation Rhizotomy
Arm Type
Active Comparator
Arm Description
Patients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy
Intervention Type
Procedure
Intervention Name(s)
Balloon Compression Rhizotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Thermal Coagulation Rhizotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain relief using numeric rating scale
Description
Worst pain in the last 24h scale in the Brief Pain Inventory
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in how the pain is perceived by the patient assessed by the Short-Form of the McGill Pain Questionnaire
Description
Short-Form of the McGill Pain Questionnaire
Time Frame
6 months
Title
Changes in neuropathic pain quality assessed by Douleur Neuropatique 4
Description
Douleur Neuropatique 4
Time Frame
6 months
Title
Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory
Description
Brief Pain Inventory
Time Frame
6 months
Title
Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory
Description
Neuropathic Pain Symptom Inventory
Time Frame
6 months
Title
Changes in quality of life assessed by World Health Organization Quality of Life - brief form
Description
World Health Organization Quality of Life - brief form
Time Frame
6 months
Title
Both patient and investigator impression in the treatment assessed by Global Clinical Impression
Description
Global Clinical Impression
Time Frame
6 months
Title
Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale
Description
Pain Catastrophizing Scale
Time Frame
6 months
Title
Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression
Description
Hospital Anxiety and Depression
Time Frame
6 months
Title
Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing
Description
Quantitative Sensorial Testing
Time Frame
6 months
Title
Changes in olfactory threshold assessed by isopropanol solution
Description
Olfactory Threshold using isopropanol solution
Time Frame
6 months
Title
Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions
Description
Gustatory Threshold using sweet, sour, salty and bitter solutions
Time Frame
6 months
Title
Changes in salivary flow assessed using cotton weights
Description
Evaluation of salivary flow using cotton weights
Time Frame
6 months
Title
Changes in olfactory discrimination assessed using Sniffin' Sticks
Description
Using Sniffin' Sticks to evaluate olfactory discrimination
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Ciampi, MD, PhD
Organizational Affiliation
HCFMSUP
Official's Role
Study Chair
Facility Information:
Facility Name
HCFMSUP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

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

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