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Electrical Acupoint Stimulation for Postoperative Recovery (EAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249701
Recruitment Status : Unknown
Verified March 2018 by weiliang zhang, Shandong University of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2017
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
weiliang zhang, Shandong University of Traditional Chinese Medicine

Brief Summary:
This study investigates electrical acupoint stimulation (EAS) administered in peri-operation for improving postoperative recovery in elder patients, who accept knee arthroplasty. the surgery cause to change of stress response, which might be associated with postoperative recovery of patient Totally, three groups are created, 1/3 participants receive transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture, the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.

Condition or disease Intervention/treatment Phase
Postoperative Complications Postoperative Nausea and Vomiting Postoperative Infection Postoperative Delirium Postoperative Pneumonia Deep Vein Thrombosis Postoperative Retention of Urine Postoperative Recovery Device: Transcutaneous Electrical Acupoint Stimulation Device: Electroacupuncture Device: sham Transcutaneous Electrical Acupoint Stimulation Not Applicable

Detailed Description:
Theoretically, the application of electrical acupoint stimulation (EAS) base on the theory of traditional Chinese medicine. It deems that a surgery might consume Qi, then cause to imbalance of Qi and Blood, especially in elder patients. Besides, surgery lead to change of stress response (hormones). The EAS administration intra-operatively perhaps be beneficial to recovery of patients, reduce the incidence of postoperative complications. The main possible mechanism was stress response regulation. The hypothesis is that the EAS improve postoperative recovery of patient through regulating stress response.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants divided into 3 groups randomized, one group receive transcutaneous electrical acupoint stimulation, one group receive electroacupuncture, the third group only connect to acupoints without stimulation.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The intervention administered randomly to the participants. The participants, care providers, investigator, outcomes assessor done their job, separately. The blind will be controlled by a assigned investigator.
Primary Purpose: Prevention
Official Title: Electrical Acupoint Stimulation for Postoperative Recovery After Knee Arthroplasty. A Randomized, Double-blind, Clinical Trial.
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : October 30, 2019

Arm Intervention/treatment
Experimental: TEAS group
Transcutaneous Electrical Acupoint Stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao. Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
Device: Transcutaneous Electrical Acupoint Stimulation
The intervention will be administered by electrical acupoint machine, the brand is Great Wall.

Placebo Comparator: Electroacupuncture group
Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
Device: Electroacupuncture
The intervention will be administered by electrical acupoint machine, the brand is Great Wall.

Sham Comparator: sham TEAS group
Sham transcutaneous electrical acupoint stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao; Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
Device: sham Transcutaneous Electrical Acupoint Stimulation
The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.




Primary Outcome Measures :
  1. The postoperative recovery [ Time Frame: 7 days ]
    Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.


Secondary Outcome Measures :
  1. The adverse event [ Time Frame: 7 days ]
    Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al.

  2. The level of stress response [ Time Frame: up to 7 days ]
    Assess the level of preoperative stress response at 1, 3, 7 days after operation. It mainly include Adrenocorticotropic Hormone (ACTH), Cortisol (COR), Adrenaline (E), norepinephrine (NE). All measures unit is pg/ml.

  3. Postoperative complications [ Time Frame: 7 days ]
    Record the incidence of any postoperative complications during 7 days

  4. The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10 [ Time Frame: up to 7 days ]
    Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation. It mainly include Tumor Necrosis Factor-a (TNF-a), Interleukins-1 (IL-1), Interleukins-6 (IL-6), Interleukins-10 (IL-10). All measures unit is ng/ml.

  5. The level of inflammatory response by C-reactive protein [ Time Frame: up to 7 days ]
    Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation through C-reactive protein. the unit is mg/L.


Other Outcome Measures:
  1. Age in years [ Time Frame: 1 day ]
    Once patients enrolled, the age (years) need to be recorded ahead of operation.

  2. ASA classification status [ Time Frame: 1 day ]
    Once patients enrolled, the ASA condition need to be recorded ahead of operation depend on the ASA classification.

  3. Gender [ Time Frame: 1 day ]
    Once patients enrolled, the gender need to be recorded ahead of operation.

  4. Weight in kilograms [ Time Frame: 1 day ]
    Once patients enrolled, the weight (kilograms) need to be recorded ahead of operation.

  5. Height in meters [ Time Frame: 1 day ]
    Once patients enrolled, the height (meters) need to be recorded ahead of operation.

  6. BMI in kg/m^2 [ Time Frame: 1 day ]
    Once patients enrolled, the BMI (weight and height will be combined to report BMI in kg/m^2) will be reported base on weight and height ahead of operation.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Agree to sign the contract
  • The patients receive total hip or knee arthroplasty
  • Epidural anesthesia administered

Exclusion Criteria:

  • The patients' age out of range setting
  • Forbidden to the administration of transcutaneous electrical acupoint stimulation
  • Communication disorder
  • The patients who had medical history of cerebral vascular diseases, deep vein thrombosis, urinary retention, nausea and vomiting.
  • The patients who attended another trial in the past three months
  • Emergency surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249701


Contacts
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Contact: zhang weiliang, MD 086-0531-68617021 ext 6114 hezhangweiliang@163.com
Contact: Su Fan, MD 086-0531-68617023 ext 6114 boatsail@163.com

Locations
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China, Shandong
Affiliated hospital of shandong university of traditional chinese medicine
Ji'nan, Shandong, China, 250011
Contact: zhang weiliang, MD    086-0531-68617021 ext 6114    hezhangweiliang@163.com   
Contact: Su Fan, MD    086-0531-68617023 ext 6114    boatsail@163.com   
Sponsors and Collaborators
Shandong University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Su Fan, MD Shandong University of Traditional Chinese Medicine
  Study Documents (Full-Text)

Documents provided by weiliang zhang, Shandong University of Traditional Chinese Medicine:
Informed Consent Form  [PDF] March 28, 2018

Publications of Results:

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Responsible Party: weiliang zhang, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03249701    
Other Study ID Numbers: SZH-A-20170501-R2
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD sharing content included the intervention protocol, record or data collected for the primary and secondary outcome measures.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion, forever.
Access Criteria: Anyone are available to access the data collected on this website with requiring to sign the Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by weiliang zhang, Shandong University of Traditional Chinese Medicine:
Acupoint Stimulation
postoperative recovery
Postoperative Complications
Peri-operation
Additional relevant MeSH terms:
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Pneumonia
Delirium
Urinary Retention
Thrombosis
Venous Thrombosis
Vomiting
Postoperative Complications
Postoperative Nausea and Vomiting
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes
Urination Disorders
Urologic Diseases