Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty

Study Overview
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Brief Summary
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This is a single center, randomized, double-blinded, controlled clinical trial. The purpose of this study is to to determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative complications in patients undergoing artificial joint replacement surgery.

Detailed Description
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The complications from patients accepted artificial joint replacement surgery will directly or indirectly affect the prognosis of the patients, resulting in patients with delayed recovery and increase the hospitalization time and cost. Serious complications can lead to patients deaths during perioperative period. It has been proved that the electroacupuncture application during perioperative period can reduce the dosage of anesthetic drugs, and has a good effect on the protection of the heart and brain. At the same time, the electroacupuncture can also regulate the body's immune function, reduce allergy, reduce postoperative pain and so on.Compared with acupuncture, transcutaneous electric acupoint stimulation (TEAS) is a noninvasive technique that has similar effects to acupuncture. The investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after artificial joint replacement surgery.

Official Title
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The Protective Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty: A Single-Center, Double-Blinded, Randomised Controlled Trial

Conditions
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Joint Replacement

Intervention / Treatment
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* Device: TEAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASAⅡ-Ⅲ,elective operation patients No other severe complications history Able to give informed consent Exclusion Criteria: Having severe comorbidity resulting in estimated life expectancy <1 year. Infection at the electroacupuncture site. Suffered from neurologic disorder or impaired mental state Participate in the other clinical trial 3 months before the enrollment No suitable to participate in this experiment

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEAS group<br>Electric stimulation was given through electrode attached to acupoints SP6 and ST36 .TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery. | Device: TEAS<br>* Transcutaneous electrical acupoint stimulation<br>|
| Sham Comparator: Sham group<br>Non-acupoint is located 2cm inward to the specific acupoints.TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery. | Device: TEAS<br>* Transcutaneous electrical acupoint stimulation<br>|
| Placebo Comparator: Control group<br>Control patients will receive the same treatment without electrical stimulation. | Device: TEAS<br>* Transcutaneous electrical acupoint stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative complications | Participants will be followed for the incidence of postoperative complications | within 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of postoperative hospital stay | Participants will be followed for the duration of hospital stay | an expected average of 1 week | 
| Quality of life during 30 days after surgery | evaluate the quality of life after surgery by WHO QOL-BREF scale with interview ，WHO QOL-BREF scale includes five aspects: physical, psychological, social, environmental, integrated, divided into five levels | One month | 
| ICU transfer rate after operation | Participants will be followed for ICU transfer rate after operation | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TEAS, complication