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A clinical study on the improvement of pain after total knee arthroplasty by auricular pressure and tendon manipulation

Registration number：

ITMCTR2024000435

Date of Last Refreshed on：

2024-09-13

Date of Registration：

2024-09-13

Registration Status：

Retrospective registration

Public title：

A clinical study on the improvement of pain after total knee arthroplasty by auricular pressure and tendon manipulation

English Acronym：

Scientific title：

A clinical study on the improvement of pain after total knee arthroplasty by auricular pressure and tendon manipulation

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Xiaobo Sun/Yuanchi Huang

Study leader：

Xiaobo Sun

Applicant telephone：

15735213367

Study leader's telephone：

15735213367

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1141839847@qq.com

Study leader's E-mail：

1141839847@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

555 Youyi Road East Nanshaomen Beilin District Xi'an Shaanxi

Study leader's address：

555 Youyi Road East Nanshaomen Beilin District Xi'an Shaanxi

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Xi'an Honghui Hospital

Approved by ethic committee：

Approved No. of ethic committee：

202408012

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Xi'an Honghui Hospital

Date of approved by ethic committee：

2024/8/21 0:00:00

Contact Name of the ethic committee：

Ning Ning

Contact Address of the ethic committee：

555 Youyi Road East Nanshaomen Beilin District Xi'an Shaanxi

Contact phone of the ethic committee：

+86 29 8526 0259

Contact email of the ethic committee：

hhyyiec@163.com

Primary sponsor：

Department of Knee Joints Xi'an HongHui Hospital

Primary sponsor's address：

555 Youyi Road East Nanshaomen Beilin District Xi'an Shaanxi

Secondary sponsor：

Country：

China

Province：

Shaanxi

City：

Xi'an

Institution
hospital：

Xi'an HongHui Hospital

Address：

555 Youyi Road East Nanshaomen Beilin District

Source(s) of funding：

Self-funded

Target disease：

Knee arthritis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

The objective of this study was to evaluate the clinical effect of auricular point compression and tendon manipulation on pain after total knee arthroplasty.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Overall physical condition is I-III according to the American College of Anesthesiologists (ASA) score; (2) Preoperative diagnosis of knee osteoarthritis mainly unilateral symptoms conservative treatment failed; (3) Unilateral TKA is planned; (4) Patients aged 50-80 years; (5) Those who are not allergic to the auricular point pressure bean in this study; (6) Be willing to provide written informed consent and participate in and comply with the study.

Exclusion criteria：

(1) Patients undergoing bilateral TKA unicondylar knee replacement or revision; (2) Patients with severe lesions in both knee joints; (3) Cardiovascular disease diabetes and perioperative blood glucose control was poor (fasting blood glucose > 8 mmol/L) severe Patients with severe renal insufficiency severe liver insufficiency history of gastric ulcer and coagulation disorders; (4) a history of stroke or neurological or psychiatric illness (serious mental illness psychological problems and inability to communicate); (5) Past drug addiction drug use history narcotic drug dependence drug abuse history and the use of hormone drugs treatment; (6) Patients who are allergic to the drug in this study and have pruritus and ulceration of the skin at the treatment site; Body mass index (BMI)>35kg/m2; (8) There is serious ligament instability; (9) Central and peripheral nervous system problems that cannot complete the postoperative rehabilitation program.

Study execute time：

From 2024-08-22

To      2025-04-30

Recruiting time：

From 2024-09-02

To      2025-03-31

Interventions：

50

Group：

Test group

Sample size：

Intervention：

Perioperative routine analgesia regimen+uricular pressure and tendon manipulation

Intervention code：

50

Group：

Control group

Sample size：

Intervention：

Perioperative routine analgesia regimen

Intervention code：

Total sample size ： 100

Countries of recruitment
and research settings：

Country：

China

Province：

Shaanxi

City：

Xi'an

Institution/hospital：

Xi'an HongHui Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Interleukin-6

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Opioid use

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

deep venous thrombosis

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

knee motion

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Operative area infection

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Pain level

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

nausea and vomiting

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

C-reactive protein

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

50
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Computer-generated random numbers were generated by blinded nurses other than investigators using sealed envelopes.

Blinding：

Double blind: Researcher and subject are blinded.

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

no

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF and EDC

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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