AuriculotherapyNCT06273488
The Role of Auricular Point Diagnosis and Treatment in ERAS During TKA
An observational study of Auriculotherapy and Arthroplasty, Replacement, Knee, run by Peking Union Medical College at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Auriculotherapy, Arthroplasty, Replacement, Knee, Enhanced Recovery After Surgery
- What is being tested?
- Auriculotherapy
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: 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.
- Being tested
- Auriculotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuriculotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Auriculotherapy intervention group | Not described Receives: Other: Auriculotherapy | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: 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.
Measured: Within 3 days before surgery
Acupoint electrical measurement value(AE)
Measure the electrical measurement values of acupoints in corresponding parts of the body through a meridian analyzer.
Measured: 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.
Measured: Within 1 months after surgery
Hospital stay
Including wish days during acute and recovery periods
Measured: Within 1 months after 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.
Measured: 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.
Measured: 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.
Measured: postoperative days 1-4, 7 and 14
C-reactive protein (CRP)
This indicator was collected through review of medical records
Measured: Within 3 days before surgery and 4 days after surgery
Erythrocyte Sedimentation Rate(ESR)
This indicator was collected through review of medical records.
Measured: 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.
Measured: 1 month after surgery
Expenses during hospitalization
This indicator was collected through review of medical records
Measured: Within 3 days after the patient leaves the surgical hospital
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.
Measured: 1 month after surgery
Adverse events related to auricular acupuncture diagnosis and treatment
Adverse events related to auricular acupuncture diagnosis and treatment
Measured: Within 1 month after surgery
Affected limb drainage volume
This indicator was collected through review of medical records
Measured: Within 4 days 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
Measured: 24±2h after the start of AP or first visit, 12±2h before surgery, and 2 h before surgery.
patient-controlled analgesia (PCA) pressing times
This indicator was collected through review of medical records
Measured: postoperative Days 1-4
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
Measured: 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).
Measured: 2 h before surgery
AROM
Measured: 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.
Measured: postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start23 Mar 2024
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AuriculotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qindong Mi, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273488
- Sponsor's protocol ID
- EXZL20240002
- Status last verified
- Dec 2025
- First submitted
- 31 Jan 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Auricular Acupoint Diagnosis and Therapy in Enhanced Recovery After Surgery of Total Knee Arthroplasty Based on Real World Study
- ClinicalTrials.gov ID
- NCT06273488
- Acronym / sponsor ID
- EXZL20240002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auriculotherapy intervention group | – | Other: Auriculotherapy |
| Control group | – | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AuriculotherapyTreatment 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. | Other | Auriculotherapy intervention group |
Primary outcome
Changes in Range of motion(△AROM)
Time frame: 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.
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.
21 secondary outcomes
Facial Visual Analog Scale (VAS-F)
Time frame: preoperatively and on postoperative Days 1-4, 7 and 14 during early rehabilitation exercise
Self-Assessment Survey for Anxiety(SAS)
Time frame: Within 3 days before surgery
Acupoint electrical measurement value(AE)
Time frame: Within 3 days before surgery and 1 month after surgery
Dosage of painkillers
Time frame: Within 1 months after surgery
Hospital stay
Time frame: Within 1 months after surgery
HSS knee joint scoring
Time frame: postoperative Days 7 and 14
Thigh circumference(knee joint circumference)
Time frame: postoperative days 1-4, and 14
Kine siphobia (TSK) score
Time frame: postoperative days 1-4, 7 and 14
C-reactive protein (CRP)
Time frame: Within 3 days before surgery and 4 days after surgery
Erythrocyte Sedimentation Rate(ESR)
Time frame: Within 3 days before surgery and 4 days after surgery
Postoperative satisfaction
Time frame: 1 month after surgery
Expenses during hospitalization
Time frame: Within 3 days after the patient leaves the surgical hospital
Demand rate and satisfaction rate of auricular point diagnosis and treatment
Time frame: 1 month after surgery
Adverse events related to auricular acupuncture diagnosis and treatment
Time frame: Within 1 month after surgery
Affected limb drainage volume
Time frame: Within 4 days after surgery
Preoperative Anxiety Scale (PAS-7) score
Time frame: 24±2h after the start of AP or first visit, 12±2h before surgery, and 2 h before surgery.
patient-controlled analgesia (PCA) pressing times
Time frame: postoperative Days 1-4
Modified Pittsburgh Sleep Quality Index (M-PSQI)
Time frame: 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)
Time frame: 2 h before surgery
AROM
Time frame: 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)
Time frame: postoperative day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auriculotherapy and Arthroplasty, Replacement, Knee, run by Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Range of motion(△AROM) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.