The Role of Auricular Point Diagnosis and Treatment in ERAS During TKA

NCT06273488 | Completed DMC

• 1 other identifier: EXZL20240002
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Auriculotherapy; Arthroplasty, Replacement, Knee; Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (1)

• Changes in Range of motion(△AROM)

  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.

  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.

Secondary Outcomes (21)

• 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

Study Arms (2)

Auriculotherapy intervention group

Other: Auriculotherapy

Control group

Interventions

Auriculotherapy OTHER

Treatment of pain, drug addictions, or other ailments by stimulating the various points on the external ear (EAR AURICLES). It is based on the ancient Chinese practices of EAR ACUPUNCTURE, but sometimes magnets and other modes of stimulation are used.

Auriculotherapy intervention group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

Auriculotherapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 22, 2024
• Study Start: March 23, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)