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临床试验/NCT03049605
NCT03049605已完成2 期

Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Neuropathy in Diabetic Patients

Imam Abdulrahman Bin Faisal University0 个研究点目标入组 65 人开始时间: 2014年1月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
65
主要终点
Motor and sensory conduction velocity of the lower limb nerves

研究概览

简要总结

This study are to:

  • Evaluate effect of magnetic therapy on peripheral neuropathy in diabetic patients.
  • Evaluate effect of laser therapy on peripheral neuropathy in diabetic patients.
  • Compare effects of magnetic therapy with that of laser therapy on peripheral neuropathy in diabetic patients.

详细描述

Sixty- five male and female diabetic patients with peripheral neuropathy will be selected to participate in this study. They will be equally divided into two groups Group-I: Twenty five patient with diabetic peripheral neuropathy will be exposed to low intensity pulsed magnetic therapy Group-II: Twenty five patients with diabetic peripheral neuropathy will be exposed for 24 treatment sessions of laser therapy Group-III 15 patient received only medical 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
Double (Participant, Investigator)

盲法说明

By randomization of participants recruitment

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All diabetic patients with peripheral neuropathy will be selected to participate in this study.
  • Their age ranges from 35 to 65 years old.
  • All patients under medical control (optimal blood glucose). such as analgesic medications (e.g. opiates, anti-depressants, anticonvulsants and diabetic drugs to control blood glucose).

排除标准

  • Patients have DPN due to other causes than diabetes
  • Ulcers in either foot
  • Lack of blood sugar control
  • Other nervous system impairments
  • Visual problems
  • Unstable medical conditions
  • Pregnancy
  • Metallic implants
  • Alcohol or drug abuse.

研究组 & 干预措施

Magnetic Therapy

Experimental

Twenty five patient were exposed to low intensity pulsed magnetic therapy with a frequency of 200 Hertz and intensity of 50 Gauss for 30 minutes / session for 2 times per week for 3 months .

干预措施: Magnetic therapy (Device)

Laser Therapy

Experimental

Twenty five patients were treated with 24 sessions of laser therapy at a rate of two sessions / week for three months. Each patient will be exposed to Helium neon infrared laser (850 nano-meter continuous wave mode from a comfortable prone lying position.

干预措施: laser therapy (Device)

Medical therapy

Experimental

Fifteen patients were received only medical treatment .

干预措施: Only medical treatment (Drug)

结局指标

主要结局

Motor and sensory conduction velocity of the lower limb nerves

时间窗: 30-45 minutes

it is used for measuring motor and sensory conduction velocity: For this purpose nerve conduction studies (NCSs) will be performed for all patients including evaluation of bilateral peroneal and tibia motor nerves and sural sensory nerves (Asad 2009). Patients with NCV from 33-48m /sec will be recruited in this study (Pericz and Cvetkovic 2006 , and Graak 2009). All measurement will be done at stander room temperature of 25 c. The skin temperature of the leg was maintained at 37ᴄ. (Asad et al 2009).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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