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

Completed

• Conditions: Arthroplasty, Replacement, Knee; Auriculotherapy; Enhanced Recovery After Surgery

• Registration Number: NCT06273488
• Lead Sponsor: Peking Union Medical College

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-22
• Study Start: 2024-03-23
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Range of motion(ROM)	Within 3 days before surgery and 1 month after surgery	The distance and direction to which a bone joint can be extended. Range of motion is a function of the condition of the joints, muscles, and connective tissues involved. Joint flexibility can be improved through appropriate MUSCLE STRETCHING EXERCISES.

Secondary Outcome Measures

Name	Time	Method
Dosage of painkillers	Within 1 months after surgery	Including the dosage of non steroidal anti-inflammatory drugs and the number of times the pain pump is pressed.
Hospital stay	Within 1 months after surgery	Including wish days during acute and recovery periods
C-reactive protein (CRP)	Within 3 days before surgery and 4 days after surgery	This indicator was collected through review of medical records
Erythrocyte Sedimentation Rate(ESR)	Within 3 days before surgery and 4 days after surgery	This indicator was collected through review of medical records.
Postoperative satisfaction	1 month after surgery	Investigate patients' satisfaction with auricular acupuncture diagnosis and treatment mainly through telephone follow-up.
Visual Analogue Pain Scale (VAS)	Within 3 days before surgery and 1 month after surgery	The VAS score usually uses a ruler about 10 centimeters long, with a scale from 0 to 10, where 0 represents painless and 10 represents the most unbearable pain. The patient selects a corresponding scale on the scale to indicate the intensity of pain based on their own pain perception. For example, 0 represents painlessness, 1 to 3 represents mild pain, 4 to 6 represents moderate pain, and 7 to 10 represents severe pain. This scoring method is simple, objective, and highly sensitive. This study aims to observe the effect of ear acupoint therapy on postoperative pain relief in total knee joint surgery.
Self-Assessment Survey for Anxiety（SAS）	Within 3 days before surgery and 1 month after surgery	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.
Acupoint electrical measurement value(AE)	Within 3 days before surgery and 1 month after surgery	Measure the electrical measurement values of acupoints in corresponding parts of the body through a meridian analyzer.
Thigh circumference(knee joint circumference)	Within 3 days before surgery and 1 month after surgery	The leg circumference measurement method is mainly used to evaluate the swelling of lower limbs after TKA.
Kine siphobia (TSK) score	Within 1 month after surgery	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.
Expenses during hospitalization	Within 3 days after the patient leaves the surgical hospital	This indicator was collected through review of medical records
Demand rate and satisfaction rate of auricular point diagnosis and treatment	1 month after surgery	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.
Adverse events related to auricular acupuncture diagnosis and treatment	Within 1 month after surgery	Adverse events related to auricular acupuncture diagnosis and treatment
Affected limb drainage volume	Within 4 days after surgery	This indicator was collected through review of medical records
HSS knee joint scoring	Within 3 months after surgery	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.
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.	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
Total number of pain pump uses (presses)	Within 4 days after surgery	This indicator was collected through review of medical records
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.	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: 1. Sleep Process Metrics: Sleep latency, total sleep duration, wake time; 2. Sleep Disturbance Manifestations: Difficulty falling asleep, nocturnal awakening frequency, environmental/physiological sleep disruptions; 3. Subjective Sleep Quality: Patients' overall evaluation of sleep quality; 4. Medication Use: Frequency of sedative-hypnotic drug use; 5. 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
Patient Satisfaction with Pre-operative Preparation Assessed with the Visual Analogue Scale (VAS-Satisfaction)	2 h before surgery	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).

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing Municipality, China