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

Not Applicable

• Conditions: Joint Replacement
• Interventions: Device: TEAS

• Registration Number: NCT02979028
• Lead Sponsor: Second Hospital of Shanxi Medical University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-01
• Last Update Submitted: 2017-04-15
• Last Update Posted: 2017-04-18
• Study Start: 2017-05-01
• Primary Completion: 2018-03
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. ASAⅡ-Ⅲ,elective operation patients
2. No other severe complications history
3. Able to give informed consent

Exclusion Criteria

1. Having severe comorbidity resulting in estimated life expectancy <1 year.
2. Infection at the electroacupuncture site.
3. Suffered from neurologic disorder or impaired mental state
4. Participate in the other clinical trial 3 months before the enrollment
5. No suitable to participate in this experiment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group	TEAS	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.
Control group	TEAS	Control patients will receive the same treatment without electrical stimulation.
TEAS group	TEAS	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.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative complications	within 30 days after operation	Participants will be followed for the incidence of postoperative complications

Secondary Outcome Measures

Name	Time	Method
length of postoperative hospital stay	an expected average of 1 week	Participants will be followed for the duration of hospital stay
Quality of life during 30 days after surgery	One month	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
ICU transfer rate after operation	One month	Participants will be followed for ICU transfer rate after operation