Efficacy of Capacitive-Resistive Noninvasive Radiofrequency in Improving Perfusion Index and Attenuating Diabetic Neuropathic Pain; A Pre-post Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change of the perfusion index at the end of the first session compared to baseline readings.
研究概览
简要总结
Peripheral neuropathy increases the prevalence of diabetic foot ulcers following a decrease in foot sensation. Therefore, the treatment of this disorder is very important.
详细描述
The current study aimed to investigate the efficacy of TECAR therapy on lower limb perfusion index (PI) and to evaluate the efficacy of TECAR therapy in improving the peripheral vascularity, reducing foot pain, and improving the tactile sensation of the soles in diabetic peripheral neuropathy (DPN) patients. twenty three diabetic neuropathy patients were included in the study and underwent 12 sessions of Capacitive TECAR therapy over one month. Pain, tactile sensation of the sole and PI were evaluated at the start and after each session till the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-70 years
- •Type II DM with DPN (grade I-II) in lower limbs
- •Duration of DM>5 years
- •Visual Analog Scale (VAS) ≥3 in the feet
- •Sensory impairments in the lower extremities
排除标准
- •Patient with previous stenting or surgical intervention of lower limb arterial system.
- •Patients with previous history of DVT.
- •Pregnancy
- •Diabetic infectious wound
- •Cardiac pacemaker presence
- •Severe liver and kidney dysfunction or history of heart and lung disease.
结局指标
主要结局
Change of the perfusion index at the end of the first session compared to baseline readings.
时间窗: 40 minutes
the perfusion index readings will be taken before the first session and set as baseline reading and after the first session and the change will be calculated.The Masimo SET "Mighty-Sat Fingertip Pulse Oximetry" (Masimo Corporation, Irvine, CA, USA model 9900) was attached to the big toe of each patient. the reading will be the the mean of three measurements of perfusion index (PI) taken at one-minute intervals.
次要结局
- Visual Analogue Scale(2 months)
- Tactile sensation of the sole(2 months)
- The total remission rate(2 months)
- Analgesic effect(2 months)
研究者
Bassant M. Abdelhamid
Professor
Cairo University