Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty
TEAS
The Protective Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty: A Single-Center, Double-Blinded, Randomised Controlled Trial
1 other identifier
interventional
300
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2016
CompletedFirst Posted
Study publicly available on registry
December 1, 2016
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 18, 2017
November 1, 2016
10 months
November 29, 2016
April 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of postoperative complications
Participants will be followed for the incidence of postoperative complications
within 30 days after operation
Secondary Outcomes (3)
length of postoperative hospital stay
an expected average of 1 week
Quality of life during 30 days after surgery
One month
ICU transfer rate after operation
One month
Study Arms (3)
TEAS group
EXPERIMENTALElectric 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.
Sham group
SHAM COMPARATORNon-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
PLACEBO COMPARATORControl patients will receive the same treatment without electrical stimulation.
Interventions
Eligibility Criteria
You may qualify if:
- ASAⅡ-Ⅲ,elective operation patients
- No other severe complications history
- Able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
Huddleston JI, Maloney WJ, Wang Y, Verzier N, Hunt DR, Herndon JH. Adverse events after total knee arthroplasty: a national Medicare study. J Arthroplasty. 2009 Sep;24(6 Suppl):95-100. doi: 10.1016/j.arth.2009.05.001. Epub 2009 Jul 4.
PMID: 19577884BACKGROUNDGeerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. doi: 10.1378/chest.126.3_suppl.338S.
PMID: 15383478BACKGROUNDSingh JA, Jensen MR, Harmsen WS, Gabriel SE, Lewallen DG. Cardiac and thromboembolic complications and mortality in patients undergoing total hip and total knee arthroplasty. Ann Rheum Dis. 2011 Dec;70(12):2082-8. doi: 10.1136/ard.2010.148726. Epub 2011 Oct 21.
PMID: 22021865BACKGROUNDKrecisz B, Kiec-Swierczynska M, Chomiczewska-Skora D. Allergy to orthopedic metal implants - a prospective study. Int J Occup Med Environ Health. 2012 Sep;25(4):463-9. doi: 10.2478/S13382-012-0029-3. Epub 2012 Dec 3.
PMID: 23212287BACKGROUNDHou L, Chen C, Xu L, Yin P, Peng W. Electrical stimulation of acupoint combinations against deep venous thrombosis in elderly bedridden patients after major surgery. J Tradit Chin Med. 2013 Apr;33(2):187-93. doi: 10.1016/s0254-6272(13)60123-5.
PMID: 23789215BACKGROUNDYang L, Yang J, Wang Q, Chen M, Lu Z, Chen S, Xiong L. Cardioprotective effects of electroacupuncture pretreatment on patients undergoing heart valve replacement surgery: a randomized controlled trial. Ann Thorac Surg. 2010 Mar;89(3):781-6. doi: 10.1016/j.athoracsur.2009.12.003.
PMID: 20172127BACKGROUNDNi X, Xie Y, Wang Q, Zhong H, Chen M, Wang F, Xiong L. Cardioprotective effect of transcutaneous electric acupoint stimulation in the pediatric cardiac patients: a randomized controlled clinical trial. Paediatr Anaesth. 2012 Aug;22(8):805-11. doi: 10.1111/j.1460-9592.2012.03822.x. Epub 2012 Mar 2.
PMID: 22380768BACKGROUND
Study Officials
- STUDY CHAIR
Zheng Guo
Second Hospital of Shanxi Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 29, 2016
First Posted
December 1, 2016
Study Start
May 1, 2017
Primary Completion
March 1, 2018
Study Completion
April 1, 2018
Last Updated
April 18, 2017
Record last verified: 2016-11