Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of cured persons
研究概览
简要总结
The aim of this study was to evaluate the efficacy and safety of electret static physiotherapy film developed by Beijing Youshilin science and Technology Development Co., Ltd., to treat acute soft tissue injury by sticking to the affected area
详细描述
Design of randomized, open, parallel controlled non inferiority clinical trial.A total of 60 patients were included in the trial, including 30 subjects in the experimental group and 30 subjects in the control group. The experimental disease was acute soft tissue closed injury.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute soft tissue injury diagnosed by Western Medicine
- •Ability to communicate well with the researcher and comply with the requirements of the validation
- •Participants agreed to participate in the clinical validation and follow the validation program requirements, and signed the informed consent form
排除标准
- •There are important organs (heart and lung) serious disease history, or have autoimmune disease history, such as rheumatism, SLE, or have a history of immune dysfunction, such as suffering from aids
- •Patients with cardiac pacemaker
- •Patients with open wounds
- •Pregnant and lactating women
- •Patients with history of mental illness
- •Participants participated in other medical device trials or drug clinical trials within three months
- •The researchers believe that the participants who are not eligible for clinical validation should be considered
- •Patients who need to be treated with drugs
- •Patients requiring physical therapy
研究组 & 干预措施
Electret electrostatic physiotherapyFilm
Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm
干预措施: Electret electrostatic physiotherapyFilm (Drug)
Fracture healing film
Patients with acute soft tissue injury treated with fracture healing film
干预措施: Fracture healing film (Drug)
结局指标
主要结局
Number of cured persons
时间窗: 7 days after treatment (±2 days)
Pain, swelling, bruising and other symptoms and signs of integration to reduce more than 95%, the normal joint movement
次要结局
- Number of adverse events(7 days after treatment (±2 days))
研究者
Zhang Yichong
Principal Investigator
Peking University People's Hospital