NCT05091047已完成不适用
A Pilot Evaluation of the Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain
Erchonia Corporation2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in Pain Numerical Rating Scale (NRS)
研究概览
简要总结
This study is to see if applying red and violet low-level laser light can help to reduce foot pain associated with diabetic peripheral neuropathy,
详细描述
The purpose of this study is to determine whether low level laser therapy is effective in the reduction of foot pain associated with diabetic peripheral neuropathy, when used at home by non-medical professionals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously diagnosed with diabetes-induced Peripheral Neuropathy by a qualified health Physician.
- •Over the age of 18 years of age
- •Able to read and write English.
- •Constant feet pain on-going over at least the past 3 months.
- •Subject is willing and able to refrain from consuming any OTC and/or prescription medications including muscle relaxants and/or herbal supplements and/or recreational and medical drugs including cannabis intended for the relief of pain and/or inflammation throughout the course of study participation, except for the study-specific pain relief medication of OTC Tylenol.
- •Subject is willing and able to refrain from engaging in any non-study procedure therapies for the management of foot pain throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.
- •Self-reported foot pain on the Numerical Rating Scale (NRS) is 50 or greater
排除标准
- •Pregnant or think you might be pregnant.
- •Open wounds (sores, cuts, ulcers, etc) around the feet
- •Cancerous growths around the feet
结局指标
主要结局
Change in Pain Numerical Rating Scale (NRS)
时间窗: Baseline and 3 week
The Numerical Rating Scale (NRS) assesses the level or degree of pain. With '0: no pain at all' and '100: worst pain imaginable. The subject will be asked to rate the level of foot pain he or she is experiencing at that time.
次要结局
未报告次要终点
研究者
研究点 (2)
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