Clinical trial NCT02427074: Comparison Between Radiofrequency and Balloon Compression in the Treatment of Idiopathic Trigeminal Neuralgia
Official title: Comparative Study Between Radiofrequency and Balloon Compression of the Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Trigeminal Neuralgia
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain relief using numeric rating scale
timeFrame: 6 months
Secondary outcomes:
measure: Changes in how the pain is perceived by the patient assessed by the Short-Form of the McGill Pain Questionnaire
timeFrame: 6 months
measure: Changes in neuropathic pain quality assessed by Douleur Neuropatique 4
timeFrame: 6 months
measure: Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory
timeFrame: 6 months
measure: Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory
timeFrame: 6 months
measure: Changes in quality of life assessed by World Health Organization Quality of Life - brief form
timeFrame: 6 months
measure: Both patient and investigator impression in the treatment assessed by Global Clinical Impression
timeFrame: 6 months
measure: Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale
timeFrame: 6 months
measure: Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression
timeFrame: 6 months
measure: Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing
timeFrame: 6 months
measure: Changes in olfactory threshold assessed by isopropanol solution
timeFrame: 6 months
measure: Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions
timeFrame: 6 months
measure: Changes in salivary flow assessed using cotton weights
timeFrame: 6 months
measure: Changes in olfactory discrimination assessed using Sniffin' Sticks
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: HCFMSUP
state: SP
Study officials:
affiliation: HCFMSUP
name: Daniel Ciampi, MD, PhD
role: STUDY_CHAIR
References: