Injection of Subcutaneous Glucose 10% in Small Shots is Effective in the Treatment of Diabetic Neuropathic Pain
研究概览
详细说明
Observational cohort prospective study with the following of 100 patients of type 1 and type 2 diabetes mellitus in 2 groups each group 50 patients, each group 30 males, and 20 females,35 patients with type 2 diabetes and 15 patients type 1 diabetes all have diabetic peripheral neuropathy, the second group is considered as control. the ages of all patients are between 20 and 50 years.
The first group was on subcutaneous glucose 0.5 ml per site around subcutaneous nerves in the foot region both on palm and sole.which is repeated every 2 weeks for 2 months.
Pain severity was evaluated by using the Visual Analogue Scale (VAS) which is a numerical rating scales, with a straight horizontal line of 100 mm. which is directed from the left with severe pain to the right with no pain. 1-3 = mild pain,4-6 = moderate pain,7-10 = severe pain.
The evaluation of neuropathy was done by using the Michigan Neuropathy Screening Instrument (MNSI) after translation to the Arabic language.which consists a 15 self-administered questionnaires and examination lower extremities which comprise inspection and examination of vibratory senses and ankle reflexes. A score which is more than 7 was suggested to be abnormal.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Cairo、埃及、11759
- Mahmoud Younis
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- patients 20 years to 50 years with type 1 or type 2 diabetes who have symptoms of symmetrical peripheral neuropathic pain.
- female Patients are not pregnant.
- Patient has a pain score of at least 5 on the Visual Analogue Scale (VAS).
- Patients are on their antidiabetes medication.
- patents are not on any medication for peripheral neuropathy.
- Patient must be able to complete questions on the Michigan Neuropathy Screening Instrument (MNSI).
Exclusion Criteria:
- Patient has conditions that could affect the evaluation of painful DPN, or non-diabetic neurologic disorders.
- Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
- Patient with history of drug abuse.
- patients on any drug for diabetic neuropathy like pregabalin or gabapentin. No side effects were monitored during the period of treatment.
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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on subcutaneous glucose
this group was on subcutaneous glucose 0.5 ml per site around subcutaneous nerves in the foot region both on palm and sole.which is repeated every 2 weeks for 2 months.
|
subcutaneous glucose 0.5 ml per site around subcutaneous nerves
其他名称：
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control(not receiving treatment)
the second group is considered as control.received
no treatment.
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subcutaneous glucose 0.5 ml per site around subcutaneous nerves
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Injection of subcutaneous glucose 10% in small shots is effective in treatment of diabetic neuropathic pain measured the Visual Analogue Scale (VAS)
大体时间：from baseline to 2 months
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Pain severity was evaluated by using the Visual Analogue Scale (VAS) which is a numerical rating scale, with a straight horizontal line of 100 mm.
which is directed from the left with severe pain to the right with no pain.
1-3 = mild pain,4-6 = moderate pain,7-10 = severe pain.
|
from baseline to 2 months
|
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Injection of subcutaneous glucose 10% in small shots is effective in improving neuropathic signs using the Michigan Neuropathy Screening Instrument (MNSI)
大体时间：from baseline to 2 months
|
The evaluation of neuropathy was done by using the Michigan Neuropathy Screening Instrument (MNSI) after translation to the Arabic language.
Which consists a 15 self-administered questionnaires and examination of lower extremities which comprise inspection and examination of vibratory senses and ankle reflexes.
A score which is more than 7 was suggested to be abnormal.
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from baseline to 2 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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GLUCOSE 10%的临床试验
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Cline Research CenterAbbott Diabetes Care完全的
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AerasEuropean and Developing Countries Clinical Trials Partnership (EDCTP)完全的