Comparison Between Radiofrequency and Balloon Compression in the Treatment of Idiopathic Trigeminal Neuralgia
NCT ID: NCT02427074
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
33 participants
INTERVENTIONAL
2014-02-01
2019-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Developing a Clinical Prediction Model for Adverse Outcomes in Percutaneous Trigeminal Ganglion Balloon Compression
NCT06998420
Comparative Study inTreatment of Trigeminal Neuralgia
NCT04801407
High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
NCT03131466
the Value of Sensory Index in Trigeminal Neuralgia
NCT04864964
Efficacy and Safety of Irregular Pulsed Radiofrequency (Sluijter-Teixera Poisson) Versus Regular Pulsed Radiofrequency to the Gasserian Ganglion for Treatment of Primary Trigeminal Neuralgia
NCT07275229
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Balloon Compression Rhizotomy
Patients that are submitted to Balloon Compression Rhizotomy
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
Patients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Refractory/Intolerable medical treatment
* Pain restricted to second or third trigeminal division
Exclusion Criteria
* Pain restricted to the first trigeminal division
* Refuse to participate
* Unable to comprehend the questionnaires
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sao Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hugo Sterman Neto
medical doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Ciampi, MD, PhD
Role: STUDY_CHAIR
HCFMSUP
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HCFMSUP
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1180/09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.