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

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273488
• Other study ID #: EXZL20240002
• Status: Recruiting
• Start date: March 23, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Peking Union Medical College
• Contact: Fei Bao
• Phone: 8616601203165
• Email: 785809127[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Enhanced Recovery After Surgery

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motion(ROM)	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.	Within 3 days before surgery and 1 month after surgery
Secondary	Visual Analogue Pain Scale (VAS)	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.	Within 3 days before surgery and 1 month after surgery
Secondary	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 and 1 month after surgery
Secondary	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
Secondary	Vancouver Scar Assessment Scale(VSS)	VSS is currently a commonly used scar assessment method internationally. This scale does not require special equipment and only relies on the tester's naked eye observation. It palpates the patient's scar with bare hands and measures it from four aspects: color, thickness, vascular distribution, and softness. It has the characteristics of simple operation and comprehensive content. Use this score to evaluate the postoperative scar recovery of patients.	Within 3 months after surgery
Secondary	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
Secondary	Hospital stay	Including wish days during acute and recovery periods	Within 1 months after surgery
Secondary	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.	Within 3 months after surgery
Secondary	Thigh circumference(knee joint circumference)	The leg circumference measurement method is mainly used to evaluate the swelling of lower limbs after TKA.	Within 3 days before surgery and 1 month after surgery
Secondary	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.	Within 1 month after surgery
Secondary	C-reactive protein (CRP)	This indicator was collected through review of medical records	Within 3 days before surgery and 4 days after surgery
Secondary	Erythrocyte Sedimentation Rate(ESR)	This indicator was collected through review of medical records.	Within 3 days before surgery and 4 days after surgery
Secondary	Postoperative satisfaction	Investigate patients' satisfaction with auricular acupuncture diagnosis and treatment mainly through telephone follow-up.	1 month after surgery
Secondary	Expenses during hospitalization	This indicator was collected through review of medical records	Within 3 days after the patient leaves the surgical hospital
Secondary	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
Secondary	Adverse events related to auricular acupuncture diagnosis and treatment	Adverse events related to auricular acupuncture diagnosis and treatment	Within 1 month after surgery
Secondary	Affected limb drainage volume	This indicator was collected through review of medical records	Within 4 days after surgery
Secondary	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	1 day before surgery
Secondary	Total number of pain pump uses (presses)	This indicator was collected through review of medical records	Within 4 days after surgery