Clinical trial NCT06273488: The Role of Auricular Point Diagnosis and Treatment in ERAS During TKA
Official title: The Role of Auricular Acupoint Diagnosis and Therapy in Enhanced Recovery After Surgery of Total Knee Arthroplasty Based on Real World Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Auriculotherapy
Arthroplasty, Replacement, Knee
Enhanced Recovery After Surgery
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo TKA to treat KOA in the Department of Orthopedics of Peking Union Medical College Hospital from March to December 2024.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age 50-80 years old, no gender limit;
2. Meet the late diagnostic criteria for knee osteoarthritis and meet the surgical indications for TKA;
3. The patient's auricles of both ears are intact
4. 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.
5. Subjects/guardians can understand the purpose of the trial and show sufficient compliance with the trial protocol,and signed the informed consent form (ICF).

Exclusion Criteria:

1. Suffering from severe arrhythmia, heart failure, chronic obstructive pulmonary disease, epilepsy, mental illness sick;
2. The patient's ears are damaged, red, swollen, bleeding, infected, etc. and have contraindications that are not suitable for auricular acupoint diagnosis and treatment.
3. Patients with knee varus \>15° or valgus before surgery;
4. Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.

Primary outcomes:
measure: Range of motion(ROM)
timeFrame: Within 3 days before surgery and 1 month after surgery
Secondary outcomes:
measure: Visual Analogue Pain Scale (VAS)
timeFrame: Within 3 days before surgery and 1 month after surgery
measure: Self-Assessment Survey for Anxiety（SAS）
timeFrame: Within 3 days before surgery and 1 month after surgery
measure: Acupoint electrical measurement value(AE)
timeFrame: Within 3 days before surgery and 1 month after surgery
measure: Vancouver Scar Assessment Scale（VSS）
timeFrame: Within 3 months after surgery
measure: Dosage of painkillers
timeFrame: Within 1 months after surgery
measure: Hospital stay
timeFrame: Within 1 months after surgery
measure: HSS knee joint scoring
timeFrame: Within 3 months after surgery
measure: Thigh circumference(knee joint circumference)
timeFrame: Within 3 days before surgery and 1 month after surgery
measure: Kine siphobia (TSK) score
timeFrame: Within 1 month after surgery
measure: C-reactive protein (CRP)
timeFrame: Within 3 days before surgery and 4 days after surgery
measure: Erythrocyte Sedimentation Rate(ESR)
timeFrame: Within 3 days before surgery and 4 days after surgery
measure: Postoperative satisfaction
timeFrame: 1 month after surgery
measure: Expenses during hospitalization
timeFrame: Within 3 days after the patient leaves the surgical hospital
measure: Demand rate and satisfaction rate of auricular point diagnosis and treatment
timeFrame: 1 month after surgery
measure: Adverse events related to auricular acupuncture diagnosis and treatment
timeFrame: Within 1 month after surgery
measure: Affected limb drainage volume
timeFrame: Within 4 days after surgery
measure: Preoperative Anxiety Scale (PAS-7) score
timeFrame: 1 day before surgery
measure: Total number of pain pump uses (presses)
timeFrame: Within 4 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: