Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias: a Multicentric, Controlled, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 20
- 主要终点
- Efficacy of occipital nerve stimulation
研究概览
简要总结
Medically intractable pain caused by occipital neuralgia can be very difficult to control with traditional pain management. Peripheral nerve stimulation which is used in migraines and cluster headache can be an alternative for these patients with occipital neuralgias when medical treatment and traditional pain management have failed (drugs for neuropathic pain, infiltrations, psychobehavioral approaches and multidisciplinary approach in a pain center). Occipital nerve stimulation consists to put a lead subcutaneously in front of the occipital nerve and to connect the lead to a pulse generator. A retrospective study of 60 patients was conducted in Nantes University Hospital. The results were good with the Visual Analog Scale (VAS) decreased from 8.4 preoperatively to 2.85 postoperatively. The medical quantification scale (MQS) was reduced to about 50% (18 preoperatively versus 9.9 postoperatively). Stimulation was quiet stable over time with a mean follow-up of 24 months (range 6 to 72 months). The aim of StimO is to confirm this result through a national controlled randomized multicenter study where occipital nerve stimulation will be compared to the optimal medical management.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 85 years old
- •Chronic occipital neuralgias as defined by International Headache Society (IHS) more than 6 months with permanent pain associated or not with paroxysm
- •Secondary occipital neuralgias (post-traumatic, post-surgery, major arthrosis, compression or lesion of the occipital nerve ...)
- •Chronic neuropathic pain according to the Neuropathic Pain Diagnostic Questionnaire (DN4 ≥ 4)
- •Maximum pain on VAS ≥ 50/100
- •Failure of medical treatment (association of neuropathic medication like antiepileptic and/or antidepressant and/or antalgic treatment like paracetamol, tramadol or morphine) and pain management in a pain Unit including multidisciplinary approach, physiotherapy, block test in C1-C2, radiofrequency rhizolysis, and/or corticosteroid infiltration of C2 according to the criteria defined by Health Authorities for spinal cord stimulation.
- •Reduction of pain with Transcutaneous Electrical Nerve Stimulation (TENS) in occipital area
- •Neurological examen has to be completed and must be normal except for the occipital neuralgia territory
- •A negative pregnancy test for women with childbearing potential
- •Women of childbearing potential must use appropriate method(s) of contraception during the clinical trial
- •Patients must be capable of giving informed consent and must have signed informed consent
- •Affiliation to an appropriate health insurance
排除标准
- •Contraindication to the experimental medical devices
- •Titanium related allergies
- •Patients with contraindications to general anesthesia
- •Complete anaesthesia in the C2/Great occipital nerve territory
- •Drug or alcohol addiction
- •Psychiatric disorders (psychiatric evaluation)
- •Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy)
- •Need for intensive nursing care
- •Difficulty in follow-up
- •Pregnant or lactating women
- •Women not using contraception
- •Adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")
- •Exclusion period for another study
- •Simultaneous participation in another clinical trial except if that other trial does not affect the StimO study as approved and documented by the sponsor
结局指标
主要结局
Efficacy of occipital nerve stimulation
时间窗: 6 months
Compare the decrease of pain (evaluated by visual analogic scale) after 6 months of treatment between the 2 groups (ONS / OMM)
次要结局
- Relative decrease of pain (using Visual Analogic Scale) at 3 months(3 months)
- Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 3 months(3 months)
- Quality of life (using Hamilton Anxiety and Depression (HAD) scale)(Up to 6 months)
- Maximum pain (using Visual Analogic Scale)(Up to 6 months)
- Relative decrease of pain (using Visual Analogic Scale) at 6 months(6 months)
- Quality of life (using EQ-5D-5L questionnaire)(Up to 6 months)
- Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 6 months(6 months)
- Average pain (using Visual Analogic Scale)(Up to 6 months)
- Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 3 months(3 months)
- Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 6 months(6 months)