Prospective, Randomized Study to Assess the Safety and Efficacy of the Novel Noninvasive Hypersound Neuromodulation System in the Treatment of Patients With Chronic Pain of Peripheral Nerve Origin, Including Neuropathy, Sciatica, and Joint Pain
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 主要终点
- VAS
研究概览
简要总结
First, the subject will undergo screening and provide informed consent. Baseline measurements are then taken. The subject remains seated with back support throughout the session. The technician verifies and marks the knee for treatment and wraps an antenna applicator strap around the lower leg near the knee. The device is turned on in test mode to confirm the therapy location, with the subject identifying when they feel a sensation over their pain area. The power threshold for this sensation is recorded. The therapy, which lasts 15 minutes, is delivered at 90% of this threshold to ensure the subject does not feel it. After therapy, post-treatment measurements are taken.
详细描述
- Subject will perform screening and informed consent
- Baseline measurements will be taken
- Subject will sit in chair with back support throughout duration of the session
- Knee for treatment will be verified and marked
- Technician will wrap antenna applicator strap around the lower leg, at the knee
- Device is turned on and set to test mode to verify therapy location. Subject will verify when they feel a sensation covering their existing chronic knee pain. The power threshold for sensation is recorded.
- Therapy begins and lasts for 15 minutes, power threshold is set to 90% so that the subject does not feel the therapy
- At the end of 15 minutes, post-therapy measurements are recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain greater than mid-range using standardized pain inventory (SPI).
- •No medication for pain both over-the-counter and by prescription for 24 hours prior to treatment.
- •Body mass index (BMI) to be calculated for all participants with limitation for any BMI that is lower than normal. (Target is normal, overweight or obese).
- •Age greater than 18.
排除标准
- •Existing Peripheral Nerve Stimulator Implant in the lower extremities
研究组 & 干预措施
Treatment
Recipient of Hypersound Therapy
干预措施: RF-PNS (Device)
结局指标
主要结局
VAS
时间窗: 3 months
Visual Analog Score Improvement of 50%
次要结局
- Disability(3 months)