Effectiveness of Sound Acupuncture in Painful Chemotherapy-Related Neuropathies: A Non-Invasive Alternative to Acupuncture? Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain reduction
研究概览
简要总结
The objective of this clinical trial is to evaluate the efficacy of sound acupuncture in combination with traditional medical therapy in the treatment of chemotherapy-induced peripheral neuropathies.
Sound acupuncture is a non-invasive technique that involves stimulating energy points, used in acupuncture, with the help of specific tuning forks and the frequencies they emit.
The energy points are those used in Chinese medicine and, more specifically, in acupuncture.
The aim is to restore the recipient's complex bioenergetic system to an optimal state of well-being and balance
Participants:
20 patients will receive only the best medical therapy; 20 patients will receive BMT and sound acupuncture treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-80 years
- •Clinical and electrophysiological diagnosis of chemotherapy-induced neuropathy
- •Patients being treated with Best Medical Therapy for neuropathic pain
- •Written informed consent
排除标准
- •Women who are pregnant or breastfeeding
- •Patients with intellectual disabilities or cognitive impairment that impair their ability to comply with the consent process
- •Pacemaker users
研究组 & 干预措施
Sound acupuncture
Best medical therapy + Sound Acupuncture
干预措施: Sound acupuncture (Other)
BMT
Best medical therapy
结局指标
主要结局
Pain reduction
时间窗: 1 year
At least a 30% reduction from baseline on the NPS scale for neuropathic pain
次要结局
- Back Depression inventory(1 year)
- Quality of life assessment(1 year)
研究者
Andrea Assini
MD
Ente Ospedaliero Ospedali Galliera