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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Neuropathy severity
研究概览
简要总结
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.
详细描述
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.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •patients with implant peacemakers, defibrillator, or neurostimulator.
- •pregnancy.
- •any severe disease prevent compliance to study procedures.
- •patients with disabilities prevent their commitment to sessions.
研究组 & 干预措施
conservative treatment.
干预措施: Duloxetine - low dose (Drug)
(FREMS group)
干预措施: frequency rhythmic electrical modulated stimulation. (Device)
结局指标
主要结局
Neuropathy severity
时间窗: From enrollment to the end of treatment at 10:14 days
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)
次要结局
- neuropathy effect in quality of life(From enrollment to the end of treatment at 10:14days.)
研究者
Ibtihal Nassar
physiotherapist.
Beni-Suef University