Study Stopped
Study halted due to futility
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
1 other identifier
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 18, 2015
CompletedFirst Posted
Study publicly available on registry
April 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedFebruary 13, 2020
February 1, 2020
5.2 years
April 18, 2015
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Pain relief using numeric rating scale
Worst pain in the last 24h scale in the Brief Pain Inventory
6 months
Secondary Outcomes (13)
Changes in how the pain is perceived by the patient assessed by the Short-Form of the McGill Pain Questionnaire
6 months
Changes in neuropathic pain quality assessed by Douleur Neuropatique 4
6 months
Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory
6 months
Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory
6 months
Changes in quality of life assessed by World Health Organization Quality of Life - brief form
6 months
- +8 more secondary outcomes
Study Arms (2)
Balloon Compression Rhizotomy
ACTIVE COMPARATORPatients that are submitted to Balloon Compression Rhizotomy
Radiofrequency Thermal Coagulation Rhizotomy
ACTIVE COMPARATORPatients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Idiopathic Trigeminal Neuralgia
- Refractory/Intolerable medical treatment
- Pain restricted to second or third trigeminal division
You may not qualify if:
- Secondary Trigeminal Neuralgia
- Pain restricted to the first trigeminal division
- Refuse to participate
- Unable to comprehend the questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HCFMSUP
São Paulo, São Paulo, 05403000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Daniel Ciampi, MD, PhD
HCFMSUP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
April 18, 2015
First Posted
April 27, 2015
Study Start
February 1, 2014
Primary Completion
March 31, 2019
Study Completion
August 30, 2019
Last Updated
February 13, 2020
Record last verified: 2020-02