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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
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.
HCFMSUP
São Paulo, São Paulo, Brazil
Pain relief using numeric rating scale
Worst pain in the last 24h scale in the Brief Pain Inventory
Time frame: 6 months
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
Time frame: 6 months
Changes in neuropathic pain quality assessed by Douleur Neuropatique 4
Douleur Neuropatique 4
Time frame: 6 months
Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory
Brief Pain Inventory
Time frame: 6 months
Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory
Neuropathic Pain Symptom Inventory
Time frame: 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
Time frame: 6 months
Both patient and investigator impression in the treatment assessed by Global Clinical Impression
Global Clinical Impression
Time frame: 6 months
Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale
Pain Catastrophizing Scale
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Time frame: 6 months
Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression
Hospital Anxiety and Depression
Time frame: 6 months
Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing
Quantitative Sensorial Testing
Time frame: 6 months
Changes in olfactory threshold assessed by isopropanol solution
Olfactory Threshold using isopropanol solution
Time frame: 6 months
Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions
Gustatory Threshold using sweet, sour, salty and bitter solutions
Time frame: 6 months
Changes in salivary flow assessed using cotton weights
Evaluation of salivary flow using cotton weights
Time frame: 6 months
Changes in olfactory discrimination assessed using Sniffin' Sticks
Using Sniffin' Sticks to evaluate olfactory discrimination
Time frame: 6 months