The Role of Auricular Acupoint Diagnosis and Therapy in Enhanced Recovery After Surgery of Total Knee Arthroplasty Based on Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Changes in Range of motion(△AROM)
研究概览
简要总结
To further improve the surgical outcomes of patients undergoing total knee arthroplasty (TKA). This study aims to use ear acupoint therapy to address the following clinical issues: 1 The degree of postoperative inflammation and edema in the patient; 2. Patient pain; 3. Patient functional recovery. 4. Surgical scar repair for patients; 5. Patient perioperative anxiety and postoperative satisfaction. Exploring the safety and effectiveness of ear acupoint therapy in the postoperative application of TKA, leveraging the advantages of suitable traditional Chinese medicine techniques in simplicity, convenience, effectiveness, and cost-effectiveness, and further improving the ERAS Chinese and Western medicine collaborative plan for TKA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-80 years old, no gender limit;
- •Meet the late diagnostic criteria for knee osteoarthritis and meet the surgical indications for TKA;
- •The patient's auricles of both ears are intact
- •The subject/guardian makes it clear that the patient will choose to go to a medical consortium hospital for standardized medical treatment after surgery.
- •Repeat treatment.
- •Subjects/guardians can understand the purpose of the trial and show sufficient compliance with the trial protocol,and signed the informed consent form (ICF).
排除标准
- •Suffering from severe arrhythmia, heart failure, chronic obstructive pulmonary disease, epilepsy, mental illness sick;
- •The patient's ears are damaged, red, swollen, bleeding, infected, etc. and have contraindications that are not suitable for auricular acupoint diagnosis and treatment.
- •Patients with knee varus >15° or valgus before surgery;
- •Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.
结局指标
主要结局
Changes in Range of motion(△AROM)
时间窗: The change in AROM from postoperative day 1 to day 4 (measured by trained personnel to optimize accuracy) was used as the primary outcome measure.
Active range of motion (AROM) is defined as the degree of knee flexion achieved without assistance. It is closely related to lower limb pain, kinesiophobia and swelling, and better reflects the early functional recovery of the knee joint after surgery.
次要结局
- Adverse events related to auricular acupuncture diagnosis and treatment(Within 1 month after surgery)
- Facial Visual Analog Scale (VAS-F)(preoperatively and on postoperative Days 1-4, 7 and 14 during early rehabilitation exercise)
- Self-Assessment Survey for Anxiety（SAS）(Within 3 days before surgery)
- Acupoint electrical measurement value(AE)(Within 3 days before surgery and 1 month after surgery)
- Dosage of painkillers(Within 1 months after surgery)
- Hospital stay(Within 1 months after surgery)
- HSS knee joint scoring(postoperative Days 7 and 14)
- Thigh circumference(knee joint circumference)(postoperative days 1-4, and 14)
- Kine siphobia (TSK) score(postoperative days 1-4, 7 and 14)
- C-reactive protein (CRP)(Within 3 days before surgery and 4 days after surgery)
- Erythrocyte Sedimentation Rate(ESR)(Within 3 days before surgery and 4 days after surgery)
- Postoperative satisfaction(1 month after surgery)
- Expenses during hospitalization(Within 3 days after the patient leaves the surgical hospital)
- Demand rate and satisfaction rate of auricular point diagnosis and treatment(1 month after surgery)
- Affected limb drainage volume(Within 4 days after surgery)
- Preoperative Anxiety Scale (PAS-7) score(24±2h after the start of AP or first visit, 12±2h before surgery, and 2 h before surgery.)
- patient-controlled analgesia (PCA) pressing times(postoperative Days 1-4)
- Modified Pittsburgh Sleep Quality Index (M-PSQI)(24±2h after the start of AP or first visit , 12±2h before surgery, and 72±2h post-operatively.)
- Patient Satisfaction with Pre-operative Preparation Assessed with the Visual Analogue Scale (VAS-Satisfaction)(2 h before surgery)
- AROM(AROM of the knee joint was assessed by trained personnel preoperatively and on postoperative days 1-4, 7, and 14 repectively to observe the recovery trend of AROM after surgery)
- 5-point Verbal Rating Scale (VRS-5)(postoperative day 30)
研究者
Qindong Mi
research assistant
Peking Union Medical College