A Comparative Study Of Botulinum Toxin Type A Versus Conventional Oral Therapy As A Second Line Treatment Of Diabetic Neuropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- visual analogue score
研究概览
简要总结
Background: Diabetes mellitus is commonly complicated by diabetic peripheral neuropathy. Due to common side effects and poor tolerance to medication, poor adherence to medication is common in diabetic peripheral neuropathy. Botulinum toxin A intradermal injection has proved efficacy in cases of diabetic peripheral neuropathy however there is a need to compare its effect with other lines of treatment. The aim of the study was to compare botulinum toxin type a verses conventional oral treatment as a second line treatment of painful diabetic peripheral neuropathy. This study was conducted as a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. Patients were divided randomly into 3 groups. First group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with botulinum toxin A.
详细描述
This study is a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. Patients were divided randomly into 3 groups.
First group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with Botulinum toxin A. Base line Assessment before treatment and follow up assessment as performed The treatment options were explained to the patients and the choice of Botulinum toxin A Intradermal injection was the patient own decision based on inability to be tolerate or adhere to oral treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic patients type 2 were included on single line of treatment with carbamazepine
排除标准
- •any sever medical condition that might interfere with the results.
研究组 & 干预措施
botulinum toxin A injection
botulinum toxin A injection
干预措施: botulinum toxin A (Drug)
gabapentin
gabapentin
干预措施: Gabapentin (Drug)
duloxetine
duloxetine
干预措施: Duloxetine (Drug)
结局指标
主要结局
visual analogue score
时间窗: 1 week ,4 weeks,12 weeks
change visual analogue score zero no pain ,10 unbearable pain
Pittsburgh sleep quality index
时间窗: 1 week ,4 weeks,12 weeks
change Pittsburgh sleep quality index 0-21 ,above 5 indicates sleep disturbance
次要结局
未报告次要终点
研究者
Eman Hamdy
Principal investigator
Alexandria University