Effectiveness of Transcranial Direct Current Stimulation for TKR

March 29, 2019 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center

Effectiveness of Transcranial Direct Current Stimulation for Postoperative Pain in Total Knee Replacement Surgery

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,

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-707
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Delirium
Time Frame: postop day 1,3,6
Incidence of Delirium
postop day 1,3,6
Consumption of PCA
Time Frame: 24 hours
The consumption of opioid.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Jin-Young Hwang, MD,phD, Seoul Metropolitan Government Seoup National University Boramae Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

May 10, 2020

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/00/0000.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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