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

Shanxi Medical University

Status: Unknown

Conditions: Joint Replacement

Treatments: Device: TEAS

Study type: Interventional

Funder types: Other

Identifiers

NCT02979028

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 60 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

TEAS group

Experimental group

Description:

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.

Treatment:

Device: TEAS

Sham group

Sham Comparator group

Description:

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.

Treatment:

Device: TEAS

Control group

Placebo Comparator group

Description:

Control patients will receive the same treatment without electrical stimulation.

Treatment:

Device: TEAS