Electrical Acupoint Stimulation for Postoperative Recovery After Knee Arthroplasty. A Randomized, Double-blind, Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The postoperative recovery
研究概览
简要总结
This study investigates electrical acupoint stimulation (EAS) administered in peri-operation for improving postoperative recovery in elder patients, who accept knee arthroplasty. the surgery cause to change of stress response, which might be associated with postoperative recovery of patient Totally, three groups are created, 1/3 participants receive transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture, the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.
详细描述
Theoretically, the application of electrical acupoint stimulation (EAS) base on the theory of traditional Chinese medicine. It deems that a surgery might consume Qi, then cause to imbalance of Qi and Blood, especially in elder patients. Besides, surgery lead to change of stress response (hormones). The EAS administration intra-operatively perhaps be beneficial to recovery of patients, reduce the incidence of postoperative complications. The main possible mechanism was stress response regulation. The hypothesis is that the EAS improve postoperative recovery of patient through regulating stress response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The intervention administered randomly to the participants. The participants, care providers, investigator, outcomes assessor done their job, separately. The blind will be controlled by a assigned investigator.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to sign the contract
- •The patients receive total hip or knee arthroplasty
- •Epidural anesthesia administered
排除标准
- •The patients' age out of range setting
- •Forbidden to the administration of transcutaneous electrical acupoint stimulation
- •Communication disorder
- •The patients who had medical history of cerebral vascular diseases, deep vein thrombosis, urinary retention, nausea and vomiting.
- •The patients who attended another trial in the past three months
- •Emergency surgery
研究组 & 干预措施
TEAS group
Transcutaneous Electrical Acupoint Stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao. Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
干预措施: Transcutaneous Electrical Acupoint Stimulation (Device)
Electroacupuncture group
Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
干预措施: Electroacupuncture (Device)
sham TEAS group
Sham transcutaneous electrical acupoint stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao; Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
干预措施: sham Transcutaneous Electrical Acupoint Stimulation (Device)
结局指标
主要结局
The postoperative recovery
时间窗: 7 days
Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.
次要结局
- The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10(up to 7 days)
- The level of inflammatory response by C-reactive protein(up to 7 days)
- The adverse event(7 days)
- Postoperative complications(7 days)
- The level of stress response(up to 7 days)
研究者
weiliang zhang
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Shandong University of Traditional Chinese Medicine