Comparison Between Radiofrequency and Balloon Compression in the Treatment of Idiopathic Trigeminal Neuralgia
|ClinicalTrials.gov Identifier: NCT02427074|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2015
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Trigeminal Neuralgia||Procedure: Balloon Compression Rhizotomy Procedure: Radiofrequency Thermal Coagulation Rhizotomy||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparative Study Between Radiofrequency and Balloon Compression of the Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||September 2019|
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.
- Pain relief using the visual analogic scale [ Time Frame: 6 months ]Average pain using the visual analogic scale in the Brief Pain Inventory
- Changes in how the pain is perceived by the patient assessed by the Short-Form of the McGill Pain Questionnaire [ Time Frame: 6 months ]Short-Form of the McGill Pain Questionnaire
- Changes in neuropathic pain quality assessed by Douleur Neuropatique 4 [ Time Frame: 6 months ]Douleur Neuropatique 4
- Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory [ Time Frame: 6 months ]Brief Pain Inventory
- Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory [ Time Frame: 6 months ]Neuropathic Pain Symptom Inventory
- Changes in quality of life assessed by World Health Organization Quality of Life - brief form [ Time Frame: 6 months ]World Health Organization Quality of Life - brief form
- Both patient and investigator impression in the treatment assessed by Global Clinical Impression [ Time Frame: 6 months ]Global Clinical Impression
- Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale [ Time Frame: 6 months ]Pain Catastrophizing Scale
- Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression [ Time Frame: 6 months ]Hospital Anxiety and Depression
- Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing [ Time Frame: 6 months ]Quantitative Sensorial Testing
- Changes in olfactory threshold assessed by isopropanol solution [ Time Frame: 6 months ]Olfactory Threshold using isopropanol solution
- Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions [ Time Frame: 6 months ]Gustatory Threshold using sweet, sour, salty and bitter solutions
- Changes in salivary flow assessed using cotton weights [ Time Frame: 6 months ]Evaluation of salivary flow using cotton weights
- Changes in olfactory discrimination assessed using Sniffin' Sticks [ Time Frame: 6 months ]Using Sniffin' Sticks to evaluate olfactory discrimination
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427074
|São Paulo, SP, Brazil, 05403000|
|Study Chair:||Daniel Ciampi, MD, PhD||HCFMSUP|