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临床试验/NCT01513148
NCT01513148已完成不适用

The Effect of Light Therapy on Superficial Radial Nerve Conduction Using a Clustered Array of Infrared Super Luminous and Red Light Emitting Diodes

Shenandoah University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Nerve Conduction Velocity (Meters Per Second)

研究概览

简要总结

The introduction of light emitting diode (LED) devices as a novel treatment for pain relief in place of low-level laser warrants fundamental research on the effect of LED devices on one of the potential explanatory mechanisms: peripheral neurophysiology in vivo. A randomized controlled study will be conducted by measuring nerve conduction on the superficial radial nerve of healthy subjects (n=64). One baseline measurement and five post-irradiation recordings (2-min interval each) will be performed of the nerve conduction velocity (NCV) and peak latency (PL) and peak amplitude (PA). The experimental group (=32) will receive an irradiation of 2 J/cm2 with an infrared LED device (Dynatronics Solaris Model 705), while the placebo group will be treated by sham irradiation. The purpose of this study is to investigate the effects of LED light on the conduction velocity and amplitude of the superficial radial nerve.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • no history of neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy

排除标准

  • positive findings during the clinical screening examination suggestive of an underlying neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.
  • a history of a neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.

结局指标

主要结局

Nerve Conduction Velocity (Meters Per Second)

时间窗: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment

Change in nerve conduction velocity (m/s) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = nerve conduction velocity (NCV) - baseline NCV. A positive variance represented an increase from baseline and is interpreted as being an increase or faster velocity.

次要结局

  • Temperature (Degrees C)(pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment)
  • Negative Peak Latency (Milliseconds)(pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Todd Telemeco

Associate Professor

Shenandoah University

研究点 (2)

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