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

The Role of Auricular Acupoint Diagnosis and Therapy in Enhanced Recovery After Surgery of Total Knee Arthroplasty Based on Real World Study

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee; Enhanced Recovery After Surgery; Auriculotherapy
• Intervention / Treatment: Other: Auriculotherapy

• Study Type: Observational
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group
Auriculotherapy intervention group	Other: Auriculotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acupoint electrical measurement value(AE)	Measure the electrical measurement values of acupoints in corresponding parts of the body through a meridian analyzer.	Within 3 days before surgery and 1 month after surgery
Dosage of painkillers	Including the dosage of non steroidal anti-inflammatory drugs and the number of times the pain pump is pressed.	Within 1 months after surgery
Hospital stay	Including wish days during acute and recovery periods	Within 1 months after surgery
C-reactive protein (CRP)	This indicator was collected through review of medical records	Within 3 days before surgery and 4 days after surgery
Postoperative satisfaction	Investigate patients' satisfaction with auricular acupuncture diagnosis and treatment mainly through telephone follow-up.	1 month after surgery
Expenses during hospitalization	This indicator was collected through review of medical records	Within 3 days after the patient leaves the surgical hospital
Adverse events related to auricular acupuncture diagnosis and treatment	Adverse events related to auricular acupuncture diagnosis and treatment	Within 1 month after surgery
Affected limb drainage volume	This indicator was collected through review of medical records	Within 4 days after surgery
Erythrocyte Sedimentation Rate(ESR)	This indicator was collected through review of medical records.	Within 3 days before surgery and 4 days after surgery
Demand rate and satisfaction rate of auricular point diagnosis and treatment	The demand rate calculation formula is the total number of patients who require ear acupuncture treatment/included in this study, while the satisfaction rate calculation formula is the final patient who provides ear acupuncture treatment/patient who requires ear acupuncture treatment.	1 month after surgery
Preoperative Anxiety Scale (PAS-7) score	This scale assesses some of the patient's conditions related to surgery, and then selects the appropriate option among the 5 options based on the actual situation during the few days of hospitalization, and circles the corresponding number. The higher the score, the more severe the patient's preoperative anxiety.This scale consists of 7 questions, with a total score of 28 points. The higher the score, the more severe the patient's preoperative anxiety level is	24±2h after the start of AP or first visit, 12±2h before surgery, and 2 h before surgery.
Modified Pittsburgh Sleep Quality Index (M-PSQI)	To accommodate the short treatment duration and unique ward environment of hospitalized patients, this study modified the Pittsburgh Sleep Quality Index (PSQI) to develop an adapted version (M-PSQI) for short-term sleep assessment. The scale consists of 24 items (19 self-rated + 5 caregiver-rated), with scoring based on the 19 self-rated items, which assess the following dimensions: Sleep Process Metrics: Sleep latency, total sleep duration, wake time; Sleep Disturbance Manifestations: Difficulty falling asleep, nocturnal awakening frequency, environmental/physiological sleep disruptions; Subjective Sleep Quality: Patients' overall evaluation of sleep quality; Medication Use: Frequency of sedative-hypnotic drug use; Daytime Functional Impairment: Difficulty maintaining wakefulness, reduced task performance efficiency The scale adopts a 7-factor structure, with each factor scored on a 0-3 scale. The total score ranges from 0 to 21, with higher scores indicating more severe sleep	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)	The Visual Analogue Scale for Satisfaction (VAS-Satisfaction) is a simple, validated tool used to measure a patient's subjective satisfaction with their pre-operative preparation. It consists of a 100-mm horizontal line anchored by two extreme statements: Left anchor (0 mm): "Not satisfied at all"; Right anchor (100 mm): "Completely satisfied". The patient marks a point on the line corresponding to their level of satisfaction with the pre-operative process (This includes the information provided before surgery, the attitude of the medical staff, the arrangement of the preoperative process, and the overall experience of preoperative preparation). The score is quantified by measuring the distance (in mm) from the left anchor to the patient's mark, yielding a numerical value between 0 (lowest satisfaction) and 100 (highest satisfaction).	2 h before surgery
Facial Visual Analog Scale (VAS-F)	The Face Visual Analogue Scale (VAS-F) is a tool used to assess subjective experiences such as pain, discomfort, or emotional states. It utilizes a visual scale with facial expressions ranging from "very happy" to "very sad" or "no pain" to "worst pain imaginable," allowing patients to self-report their feelings or symptoms. Measurement Procedure: Scale Presentation:The patient is presented with a horizontal line (typically 10 cm in length) accompanied by a series of facial expressions at each end.On the left end, a "very happy" or "no pain" face is displayed, representing the best possible condition (score: 0).On the right end, a "very sad" or "worst pain imaginable" face is displayed, representing the worst possible condition (score: 10).	preoperatively and on postoperative Days 1-4, 7 and 14 during early rehabilitation exercise
Self-Assessment Survey for Anxiety（SAS）	The SAS score is a tool used to assess an individual's anxiety status, typically used in adults and adolescents. The cut-off value of the standard score is 50 points. A score below this indicates no anxiety problems, while a score above this may indicate varying degrees of anxiety problems. According to the increase in anxiety level, SAS scores can be divided into mild (50-59 points), moderate (60-69 points), and severe (over 70 points) anxiety. This study evaluated the perioperative anxiety of patients using this scale.	Within 3 days before surgery
HSS knee joint scoring	The HSS knee joint scoring system is a scoring system proposed by the Hospital for Special Surgery in the United States in 1976 to evaluate preoperative and postoperative knee joint function. It mainly includes six aspects: pain, function, joint range of motion, muscle strength, knee flexion deformity, knee instability, etc., with a maximum score of 100 points. The clinical efficacy classification is excellent>85, good 70-84, medium 60-69, and poor<59. Use this scale to comprehensively evaluate the postoperative functional recovery of the knee joint.	postoperative Days 7 and 14
Thigh circumference(knee joint circumference)	The leg circumference measurement method is mainly used to evaluate the swelling of lower limbs after TKA.	postoperative days 1-4, and 14
Kine siphobia (TSK) score	Use this scale to evaluate patients' postoperative kinesiology. This scale has 17 items in total, with a total score of 17 to 68 points. A score of >37 can be diagnosed as kinesiphobia. The higher the score, the higher the degree of kinesiphobia after TKA.	postoperative days 1-4, 7 and 14
patient-controlled analgesia (PCA) pressing times	This indicator was collected through review of medical records	postoperative Days 1-4
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)	The 5-point Verbal Rating Scale (VRS-5) is a simple method for assessing pain intensity, typically involving the following steps: Ask the patient to describe their pain using one of the following five predefined categories: 0: No pain - No discomfort or pain at all.; Mild pain - Pain is noticeable but easily tolerated.; Moderate pain - Pain is more pronounced and may interfere with daily activities.; Severe pain - Pain is intense and difficult to tolerate, significantly impacting daily life.; Very severe pain - Pain is excruciating and unbearable, often requiring immediate relief. Record the patient's response as a numerical value (0 to 4) based on their description.	postoperative day 30

Collaborators and Investigators

• Sponsor: Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Auriculotherapy
• Other Study ID Numbers: EXZL20240002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No