A Pilot Study of the Signal Relief Patch for the Treatment of Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- % change in Pain Baseline to End
研究概览
简要总结
assess the efficacy of the Signal Relief patch for the management of general musculoskeletal pain
详细描述
The Signal Relief Patch is an innovative, non-invasive technology that exists as a thin, flexible patch. The patch contains no drugs, wires, or batteries. Nano-capacitors utilized within the Signal Relief Patch were originally developed to replace military antenna systems with no additional power supply. Since development, it was incidentally found that these nano-capacitors may help control pain by working with the body's electrical system. Although the details of how these nano-capacitors facilitate the alleviation of pain are still under investigation, the possibility of reducing pain through a non-invasive, nonpharmacological method is extremely appealing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Male or female subject aged ≥ 18 years.
- •Currently seeking treatment for chronic musculoskeletal pain management.
- •Visual analog scale score > 4 at baseline.
- •Willing to refrain from the use of prescription pain medications during study participation.
- •Able and willing to provide informed consent.
排除标准
- •Receiving other investigational agents or on another clinical trial.
- •In emergent need for pain management.
- •Acute injury requiring rapid intervention or treatment.
- •The subject is using prescription medications (e.g., celecoxib, codeine, oxycodone, prednisone, etc.) for pain management regularly or PRN.
- •5. The subject is currently undergoing or planning to begin physical therapy.
- •The subject is planning to begin a new exercise routine.
- •Subject has implantable pain device, pacemaker, defibrillator, or other neuromodulation implantable device
- •Known to be pregnant.
结局指标
主要结局
% change in Pain Baseline to End
时间窗: 7 days
using visual analogue, proportion of subjects achieving at least a 30% reduction in reported pain on the visual analog scale score from baseline to the end of treatment.measurement and pain medication diary
次要结局
- Improvement in brief pain inventory score baseline to end 0-10 scale; 0 being no pain, 10 being worst pain(7 days)
- change in pain medication use baseline to end(7 days)