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

NCT ID: NCT02979028

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-04-30

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.

Conditions

Joint Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

TEAS group

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.

Group Type: EXPERIMENTAL

TEAS

Intervention Type: DEVICE

Transcutaneous electrical acupoint stimulation

Sham group

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.

Group Type: SHAM_COMPARATOR

TEAS

Intervention Type: DEVICE

Transcutaneous electrical acupoint stimulation

Control group

Control patients will receive the same treatment without electrical stimulation.

Group Type: PLACEBO_COMPARATOR

TEAS

Intervention Type: DEVICE

Transcutaneous electrical acupoint stimulation

Interventions

TEAS

Transcutaneous electrical acupoint stimulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zheng Guo

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zheng Guo

Role: STUDY_CHAIR

Second Hospital of Shanxi Medical University

Central Contacts

Xiao-ying Zhao

Role: CONTACT

zhaoxy06@163.com

13513616985

Zheng Guo

Role: CONTACT

guozheng713@163.com

89-351-3365108

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Other Identifiers

zxy

Identifier Type: -

Identifier Source: org_study_id