<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02979028</url>
  </required_header>
  <id_info>
    <org_study_id>zxy</org_study_id>
    <nct_id>NCT02979028</nct_id>
  </id_info>
  <brief_title>Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty</brief_title>
  <acronym>TEAS</acronym>
  <official_title>The Protective Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty: A Single-Center, Double-Blinded, Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Hospital of Shanxi Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Hospital of Shanxi Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center, randomized, double-blinded, controlled clinical trial. The purpose&#xD;
      of this study is to to determine whether treating by transcutaneous electrical acupoint&#xD;
      stimulation (TEAS) during perioperative could alleviate the postoperative complications in&#xD;
      patients undergoing artificial joint replacement surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The complications from patients accepted artificial joint replacement surgery will directly&#xD;
      or indirectly affect the prognosis of the patients, resulting in patients with delayed&#xD;
      recovery and increase the hospitalization time and cost. Serious complications can lead to&#xD;
      patients deaths during perioperative period. It has been proved that the electroacupuncture&#xD;
      application during perioperative period can reduce the dosage of anesthetic drugs, and has a&#xD;
      good effect on the protection of the heart and brain. At the same time, the&#xD;
      electroacupuncture can also regulate the body's immune function, reduce allergy, reduce&#xD;
      postoperative pain and so on.Compared with acupuncture, transcutaneous electric acupoint&#xD;
      stimulation (TEAS) is a noninvasive technique that has similar effects to acupuncture. The&#xD;
      investigators hypothesize that TEAS before anesthesia and during surgery would decrease the&#xD;
      morbidity and mortality of postoperative complications in 30 days after artificial joint&#xD;
      replacement surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 1, 2017</start_date>
  <completion_date type="Anticipated">April 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of postoperative complications</measure>
    <time_frame>within 30 days after operation</time_frame>
    <description>Participants will be followed for the incidence of postoperative complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of postoperative hospital stay</measure>
    <time_frame>an expected average of 1 week</time_frame>
    <description>Participants will be followed for the duration of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life during 30 days after surgery</measure>
    <time_frame>One month</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU transfer rate after operation</measure>
    <time_frame>One month</time_frame>
    <description>Participants will be followed for ICU transfer rate after operation</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Joint Replacement</condition>
  <arm_group>
    <arm_group_label>TEAS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control patients will receive the same treatment without electrical stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TEAS</intervention_name>
    <description>Transcutaneous electrical acupoint stimulation</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_label>TEAS group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASAⅡ-Ⅲ,elective operation patients&#xD;
&#xD;
          2. No other severe complications history&#xD;
&#xD;
          3. Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Having severe comorbidity resulting in estimated life expectancy &lt;1 year.&#xD;
&#xD;
          2. Infection at the electroacupuncture site.&#xD;
&#xD;
          3. Suffered from neurologic disorder or impaired mental state&#xD;
&#xD;
          4. Participate in the other clinical trial 3 months before the enrollment&#xD;
&#xD;
          5. No suitable to participate in this experiment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zheng Guo</last_name>
    <role>Study Chair</role>
    <affiliation>Second Hospital of Shanxi Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiao-ying Zhao</last_name>
    <phone>13513616985</phone>
    <email>zhaoxy06@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zheng Guo</last_name>
    <phone>89-351-3365108</phone>
    <email>guozheng713@163.com</email>
  </overall_contact_backup>
  <reference>
    <citation>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.</citation>
    <PMID>19577884</PMID>
  </reference>
  <reference>
    <citation>Geerts 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.</citation>
    <PMID>15383478</PMID>
  </reference>
  <reference>
    <citation>Singh 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.</citation>
    <PMID>22021865</PMID>
  </reference>
  <reference>
    <citation>Krecisz 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.</citation>
    <PMID>23212287</PMID>
  </reference>
  <reference>
    <citation>Hou 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.</citation>
    <PMID>23789215</PMID>
  </reference>
  <reference>
    <citation>Yang 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.</citation>
    <PMID>20172127</PMID>
  </reference>
  <reference>
    <citation>Ni 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.</citation>
    <PMID>22380768</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>April 15, 2017</last_update_submitted>
  <last_update_submitted_qc>April 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Hospital of Shanxi Medical University</investigator_affiliation>
    <investigator_full_name>Zheng Guo</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>TEAS</keyword>
  <keyword>complication</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02979028
org study id: zxy
nct id: NCT02979028
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The incidence of postoperative complications
time frame: within 30 days after operation
description: Participants will be followed for the incidence of postoperative complications
measure: length of postoperative hospital stay
time frame: an expected average of 1 week
description: Participants will be followed for the duration of hospital stay
measure: Quality of life during 30 days after surgery
time frame: One month
description: 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
measure: ICU transfer rate after operation
time frame: One month
description: Participants will be followed for ICU transfer rate after operation
arm group label: TEAS group
arm group type: Experimental
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.
arm group label: Sham group
arm group type: Sham Comparator
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.
arm group label: Control group
arm group type: Placebo Comparator
description: Control patients will receive the same treatment without electrical stimulation.
intervention type: Device
intervention name: TEAS
description: Transcutaneous electrical acupoint stimulation
arm group label: Control group
arm group label: Sham group
arm group label: TEAS group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 89 Years
healthy volunteers: No
last name: Zheng Guo
role: Study Chair
affiliation: Second Hospital of Shanxi Medical University
last name: Xiao-ying Zhao
phone: 13513616985
email: zhaoxy06@163.com
last name: Zheng Guo
phone: 89-351-3365108
email: guozheng713@163.com
citation: 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: 19577884
citation: Geerts 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: 15383478
citation: Singh 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: 22021865
citation: Krecisz 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: 23212287
citation: Hou 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: 23789215
citation: Yang 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: 20172127
citation: Ni 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: 22380768
responsible party type: Principal Investigator
investigator affiliation: Second Hospital of Shanxi Medical University
investigator full name: Zheng Guo
investigator title: professor