Comparative Study Between Radiofrequency and Balloon Compression of the Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Pain relief using numeric rating scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Trigeminal Neuralgia
- •Refractory/Intolerable medical treatment
- •Pain restricted to second or third trigeminal division
排除标准
- •Secondary Trigeminal Neuralgia
- •Pain restricted to the first trigeminal division
- •Refuse to participate
- •Unable to comprehend the questionnaires
结局指标
主要结局
Pain relief using numeric rating scale
时间窗: 6 months
Worst pain in the last 24h scale in the Brief Pain Inventory
次要结局
- Changes in neuropathic pain quality assessed by Douleur Neuropatique 4(6 months)
- Changes in how the pain is perceived by the patient assessed by the Short-Form of the McGill Pain Questionnaire(6 months)
- Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory(6 months)
- Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale(6 months)
- Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression(6 months)
- Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing(6 months)
- Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions(6 months)
- Changes in salivary flow assessed using cotton weights(6 months)
- Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory(6 months)
- Changes in quality of life assessed by World Health Organization Quality of Life - brief form(6 months)
- Both patient and investigator impression in the treatment assessed by Global Clinical Impression(6 months)
- Changes in olfactory threshold assessed by isopropanol solution(6 months)
- Changes in olfactory discrimination assessed using Sniffin' Sticks(6 months)
研究者
Hugo Sterman Neto
medical doctor
University of Sao Paulo