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Effectiveness of Transcranial Direct Current Stimulation for TKR

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ClinicalTrials.gov Identifier: NCT03898245
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Young Hwang, SMG-SNU Boramae Medical Center

Brief Summary:

Transcranial direct current stimulation (tDCS) is a technique of noninvasive cortical stimulation allowing significant modification of brain function used. Clinical application of this technique could be helpful for pain, Parkinson's disease, dystonia, cerebral palsy and dementia etc. And tDCS is safe with only mild, transient adverse effects. But there is few studies focused to postoperative states.

The aim of this project is to reveal the effect of tDCS for postoperative pain after total knee replacement surgery,


Condition or disease Intervention/treatment Phase
Transcranial Direct Current Stimulation Post Operative Pain Device: apply tDCS Device: Sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Transcranial Direct Current Stimulation for Postoperative Pain in Total Knee Replacement Surgery
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 10, 2020

Arm Intervention/treatment
Active Comparator: active tDCS
intervention : Intensity 2mA, 30minues, 7 times (post operation in 30min, in 4hrs, and 1 time a day from POD#1 to POD #7) apply tDCS
Device: apply tDCS
Intensity 2mA, 20minues, 4 times (post operation in 30min, in 4hrs, next day morning and next day afternoon) anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC

Sham Comparator: sham tDCS
Intensity 2mA, 8 seconds (but looks same as an intervention 30mins), 7 times (post operation in 30min, in 4hrs, and 1 time a day from POD#1 to POD #7) apply tDCS (sham mode)
Device: Sham tDCS
Intensity 0mA, 40 seconds, 4 times (post operation in 30min, in 4hrs, next day morning and next day afternoon) anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC




Primary Outcome Measures :
  1. VAS score [ Time Frame: 1hour, 6hours, 24 hours, 48 hours ]
    the decrease of pain scale in postop state with Visual Analog Scale.


Secondary Outcome Measures :
  1. Incidence of Delirium [ Time Frame: postop day 1,3,6 ]
    Incidence of Delirium

  2. Consumption of PCA [ Time Frame: 24 hours ]
    The consumption of opioid.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have scheduled elective spine surgery.

Exclusion Criteria:

  • Who has Cognitive dysfunction before surgery.
  • Who already has delirium before surgery.
  • Who has pain disorder ( like CRPS)
  • Who cannot reveal the one's pain.

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): NCT03898245


Contacts
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Contact: Jin-Young Hwang, MD, phD +82-10-2746-4750 mistyblue15@naver.com

Locations
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Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
SMG-SNU Boramae Medical Center
Investigators
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Principal Investigator: Jin-Young Hwang, MD,phD Seoul Metropolitan Government Seoup National University Boramae Medical Center

Publications:
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Responsible Party: Jin-Young Hwang, Associate professor, Department of Anesthesiology and Pain medicine, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT03898245     History of Changes
Other Study ID Numbers: 2018/00/0000.0
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms