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

Not Applicable

Terminated

• Conditions: Trigeminal Neuralgia
• Interventions: Procedure: Balloon Compression Rhizotomy; Procedure: Radiofrequency Thermal Coagulation Rhizotomy

• Registration Number: NCT02427074
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2014-02-01
• Study First Submitted: 2015-04-18
• Study First Submitted QC: 2015-04-24
• Study First Posted: 2015-04-27
• Primary Completion: 2019-03-31
• Study Completion: 2019-08-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Idiopathic Trigeminal Neuralgia
• Refractory/Intolerable medical treatment
• Pain restricted to second or third trigeminal division

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Exclusion Criteria

• Secondary Trigeminal Neuralgia
• Pain restricted to the first trigeminal division
• Refuse to participate
• Unable to comprehend the questionnaires

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon Compression Rhizotomy	Balloon Compression Rhizotomy	Patients that are submitted to Balloon Compression Rhizotomy
Radiofrequency Thermal Coagulation Rhizotomy	Radiofrequency Thermal Coagulation Rhizotomy	Patients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy

Primary Outcome Measures

Name	Time	Method
Pain relief using numeric rating scale	6 months	Worst pain in the last 24h scale in the Brief Pain Inventory

Secondary Outcome Measures

Name	Time	Method
Changes in neuropathic pain quality assessed by Douleur Neuropatique 4	6 months	Douleur Neuropatique 4
Changes in how the pain is perceived by the patient assessed by the Short-Form of the McGill Pain Questionnaire	6 months	Short-Form of the McGill Pain Questionnaire
Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory	6 months	Neuropathic Pain Symptom Inventory
Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale	6 months	Pain Catastrophizing Scale
Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression	6 months	Hospital Anxiety and Depression
Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing	6 months	Quantitative Sensorial Testing
Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions	6 months	Gustatory Threshold using sweet, sour, salty and bitter solutions
Changes in salivary flow assessed using cotton weights	6 months	Evaluation of salivary flow using cotton weights
Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory	6 months	Brief Pain Inventory
Changes in quality of life assessed by World Health Organization Quality of Life - brief form	6 months	World Health Organization Quality of Life - brief form
Both patient and investigator impression in the treatment assessed by Global Clinical Impression	6 months	Global Clinical Impression
Changes in olfactory threshold assessed by isopropanol solution	6 months	Olfactory Threshold using isopropanol solution
Changes in olfactory discrimination assessed using Sniffin' Sticks	6 months	Using Sniffin' Sticks to evaluate olfactory discrimination

Trial Locations

Locations (1)

HCFMSUP; 🇧🇷 São Paulo, SP, Brazil