A Comparative Analysis of Changes in Peripheral Nerve Density and Structure Following Photobiomodulation Therapy Using the REALief Therapy System for Patients With Diabetic or Chemotherapy-associated Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- change in epidermal nerve density and/or distribution
研究概览
简要总结
This study seeks to determine if photobiomodulation (PBM, or low level laser light) affects the growth and distribution of nerves int he skin. Our previous study demonstrated that the treatment we use here was effective at reducing the symptoms of neuropathy (as measured by the modified total neuropathy score) in patients who had been treated with chemotherapy. The current effort is designed to repeat this confirm this observation using a more extensive battery of survey as well as to begin to elucidate the mechanism through which photobiomodulaiton produces the effect. WE will also be attempting to determine if diabetic patients differ in terms of response from chemotherapy patients
详细描述
Consenting patients with self-reported neuropathy following either diabetes or administration of chemotherapy, will undergo sensory testing and skin biopsies of the the foot and leg prior to initiating treatment. They will undergo PBM 3 times weekly for 6 weeks with with a follow-up biopsy performed at the conclusion of therapy and sensory testing throughout. Patients will have one remote evaluation at 26 weeks to determine whether the effect, if any extinguishes.
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
- •self reported neuropathy following exposure to diabetes or chemotherapy
- •willingness to undergo biopsies and 6 weeks of therapy
排除标准
- •pregnancy
- •active cancer treatment
结局指标
主要结局
change in epidermal nerve density and/or distribution
时间窗: Change at Baseline 6 weeks, 26 weeks
nerve measures include epidermal penetration points
total nerve fiber density,
时间窗: Change at Baseline 6 weeks, 26 weeks
nerve measures
次要结局
- NTSS- Nueropathy Total Symptom Score(Change at Baseline 6 weeks, 26 weeks)
- Brief Pain index(Change at Baseline 6 weeks, 26 weeks)