Effect of repetitive Transcranial magnetic stimulation for resistant diabetic neuropathic pain: A pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To estimate the change in Visual analogue score (VAS)
研究概览
简要总结
Chronic pain is a disabling problem that is likely to increase in magnitude as the population ages. It has limited therapeutic options with only moderate efficacy and significant side effects. This study will provide initial data in the Indian context on the safety and efficacy of Repetitive transcranial magnetic stimulation as adjunct treatment in resistant painful diabetic neuropathy. If found safe and effective it can inform larger study to provide better evidence for this treatment modality and can also be expanded to include other chronic pain conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Type 2 diabetic patients with diabetic neuropathy as defined by toronto clinical neuropathy score more than 9 and resistant pain defined as visual analogue score in the last one week more than 4 while being on at least one pain relief medication.
排除标准
- •a) Any active ulcer or inflammation b) Any other cause that can explain the pain like fractures c) Past history of seizure or epilepsy in self or family.
结局指标
主要结局
To estimate the change in Visual analogue score (VAS)
时间窗: It will be estimated following 5 sessions of Repetitive Transcranial Magnetic Stimulation and also at the end of 2 weeks.
次要结局
- To estimate the change in visual analogue score at the end of 5 sessions, and at the end of 1 month and 2 month
- To evaluate safety and tolerability of repetitive transcranial magnetic stimulation in this patient population(It will be estimated at end of 1 month)
- To evaluate its effect on nerve conduction parameters, Patient global impression of change and DN4 scale.(Effect on Nerve conduction parameters will be estimated at end of 2 weeks, Patient global impression of change at end of 1 month and DN4 scale at end of 5 sessions, 2 weeks, 1 month and 2 months)
研究者
Dr Rajeswari Aghoram
Jawaharlal Institute of Postgraduate Medical Education and Research