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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Study Between Radiofrequency and Balloon Compression of the Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia

Conditions
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Trigeminal Neuralgia

Intervention / Treatment
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* Procedure: Balloon Compression Rhizotomy
* Procedure: Radiofrequency Thermal Coagulation Rhizotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balloon Compression Rhizotomy<br>Patients that are submitted to Balloon Compression Rhizotomy | Procedure: Balloon Compression Rhizotomy<br>* 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.<br>|
| Active Comparator: Radiofrequency Thermal Coagulation Rhizotomy<br>Patients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy | Procedure: Radiofrequency Thermal Coagulation Rhizotomy<br>* 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.<br>|

What is the study measuring?
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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 |