NCT06182943招募中不适用
Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain
The Third Affiliated hospital of Zhejiang Chinese Medical University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年11月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Kofoed
研究概览
简要总结
Comparison and evaluation of the difference in clinical efficacy of electroacupuncture combined with surrounding acupuncture and sham electroacupuncture groups and control group (ice compress combined with brake rest group) in the treatment of ALAS by means of musculoskeletal ultrasound technique.
详细描述
- To evaluate the efficacy and safety of electroacupuncture combined with surrounding acupuncture in the treatment of ALAS,and compare its differences and advantages with traditional therapy.
- To investigate the effect of electroacupuncture combined with surrounding acupuncture on the physiological and biochemical changes of the affected nerve,muscle and ligament, as well as its mechanism and pathway.
- To investigate the influence of treatment time,frequency,intensity,stimulation point and other factors on the therapeutic effect and mechanism,further optimize the treatment plan and improve the therapeutic effect and efficiency.
- To demonstrate the unique advantages and value of acupuncture analgesia,strengthen the concept and practice of integrated Chinese and Western medicine,and make contributions to promoting the application and development of acupuncture analgesia in the field of orthopedics and traumatology.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for a grade I or II injury;
- •Onset time≤48h;
- •The patient aged between18 and 60, gender is not limited;
- •The skin of the ankle joint on the affected side is intact, without breakage or ulceration;
排除标准
- •Combined with ankle fracture;
- •Grade III injury or complete ligament rupture;
- •Those who cannot comply with the treatment program. Those with keloid, localized combination of other skin diseases, and those who are not suitable for electroacupuncture treatment;
- •Those with serious cardiovascular, cerebrovascular, hepatic, renal, hematopoietic system or systemic failure, connective tissue disease, hemophilia, diabetes mellitus, malignant tumors, and those who are prone to bleeding tendency.
结局指标
主要结局
Kofoed
时间窗: before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.
The Kofoed evaluation system was divided into 3 items, which were evaluated before treatment, 3 weeks after treatment and after treatment. The ankle joint function was evaluated mainly from three aspects of pain, function and range of motion, with a total score of 100.
次要结局
- musculoskeletal ultrasound quantitative measurement(before（baseline,week0）and after treatment(week4).)
- circumference of ankle joint(before treatment（baseline,week0）, after treatment(week4) and 1 week after treatment（follow-up,week5）.)
研究者
Hu Qimiao
lecturer
The Third Affiliated hospital of Zhejiang Chinese Medical University
研究点 (1)
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