Frequency Rhythmic Electrical Modulated Stimulation Effect in Peripheral Neuropathy Patients Severity of Cases and Qol. (FREMS)
Effects Of Frequency Rhythmic Electrical Modulated Stimulation (FREMS) On Blood Perfusion, Neuropathy Severity And Quality Of Life In Diabetic Patients With Peripheral Neuropathy And Lower Limb Ischemia: A Randomized Controlled Trial.
It's estimated that 50% of diabetic patients will have peripheral neuropathy as a complication within 3 years of the diabetes incidence [14], the goal of the study is to investigate this problem through the following objectives:
- To measure the effect of using FREMS therapy in diabetic neuropathy in interventional group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline.
- To measure the effect of using standard of care in diabetic neuropathy in control group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline.
- To compare the results between both interventional and control group.
研究概览
地位
条件
详细说明
There are no clear guidelines for the treatment of peripheral neuropathy. While the American Diabetes Association stresses the importance of early detection and preventive measures, diagnosis and management are still on a developing path.
drugs used have common side effects; duloxetine and pregabalin patients are prone to nausea, fatigue, constipation, and decreased appetite; antidepressants may cause drowsiness, dry mouth, and muscle weakness; and opioids are prevented for long-term use due to the risk of addiction in all chronic cases like peripheral neuropathy. And most of the studies on these medications didn't report quality of life effects.
the lack of clear safe treatments with long-term effects on function and quality of life is the motive to conduct a randomized controlled trial on an objective assessment tool like duplex and a valid and reliable diagnostic tool like the neuropathy impairment score(NIS), measuring the effect of treatment on quality of life by the NORFOLK quality of life questionnaire after treatment with safe nonpharmacological treatment like FREMS therapy.
cases will be referred to the physiotherapy department by a diagnosis of peripheral neuropathy. samples will be assessed and divided into two groups randomly, Group A that will conduct a session with APTIVA FREMS therapy. Group B that will follow the conservative used treatment (doulextine and vitamin supplements) only.
The Number of sessions is 10 sessions consecutively within 10:14 days. The patients will be assessed by full neurological examination through the duplex APSV, neuropathy impairment score and NORFOLK quality of life questionnaire before and after the treatment.
outcomes will be collected by the researcher.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Ibtihal Nassar, Bsc, Msc.
- 电话号码:+201151678506
- 邮箱:scholaribtihal@gmail.com
研究联系人备份
- 姓名:Ibtihal Nassar
- 电话号码:01151678506
- 邮箱:scholaribtihal@gmail.com
学习地点
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Giza、埃及
- National diabetes institute
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接触:
- Ibtihal Nassar, Bsc, Msc.
- 电话号码:+201151678506
- 邮箱:scholaribtihal@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- patients diagnosed with DM
- patients age group above 40 years old.
- patient diagnosed with peripheral neuropathy with symptoms lasts more than 3 months.
- patients lower limb ischemia in duplex affected APSV.
Exclusion Criteria:
- patients with implant peacemakers, defibrillator, or neurostimulator.
- pregnancy.
- any severe disease prevent compliance to study procedures.
- patients with disabilities prevent their commitment to sessions.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:(FREMS group)
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FREMS is characterized by sequences of biphasic electrical stimuli, with 10 consecutive sessions applied on lower limb within 10:14 days, 40 minutes for each session.
其他名称:
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有源比较器:conservative treatment.
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peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days.
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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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blood perfusion.
大体时间:From enrollment to the end of treatment at 10:14days.
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effect of FREMS on blood perfusion by duplex.
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From enrollment to the end of treatment at 10:14days.
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Neuropathy severity
大体时间:From enrollment to the end of treatment at 10:14 days
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neuropathy symptoms like (tingling, numbness, pain, loss of sensation) will be measured through neuropathy impairment score(NIS). The higher the score the worst the symptoms are. 0 = No neurological impairment 244 = Complete loss of the assessed motor, reflex, and sensory functions (theoretical maximum) |
From enrollment to the end of treatment at 10:14 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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neuropathy effect in quality of life
大体时间:From enrollment to the end of treatment at 10:14days.
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neuropathy effect on quality of life by NORFOLK quality of life questionnaire.
136 = Worst possible quality of life (maximum neuropathy-related impairment)
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From enrollment to the end of treatment at 10:14days.
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合作者和调查者
调查人员
- 研究主任:Ayman abdallah., phd、Beni-Suef University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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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