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Effectiveness of Transcranial Direct Current Stimulation for TKR

Primary Purpose

Transcranial Direct Current Stimulation, Post Operative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
apply tDCS
Sham tDCS
Sponsored by
SMG-SNU Boramae Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transcranial Direct Current Stimulation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active tDCS

sham tDCS

Arm Description

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

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)

Outcomes

Primary Outcome Measures

VAS score
the decrease of pain scale in postop state with Visual Analog Scale.

Secondary Outcome Measures

Incidence of Delirium
Incidence of Delirium
Consumption of PCA
The consumption of opioid.

Full Information

First Posted
March 29, 2019
Last Updated
March 29, 2019
Sponsor
SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03898245
Brief Title
Effectiveness of Transcranial Direct Current Stimulation for TKR
Official Title
Effectiveness of Transcranial Direct Current Stimulation for Postoperative Pain in Total Knee Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
May 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SMG-SNU Boramae Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Direct Current Stimulation, Post Operative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Active Comparator
Arm Description
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
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
apply tDCS
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
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 Measure Information:
Title
VAS score
Description
the decrease of pain scale in postop state with Visual Analog Scale.
Time Frame
1hour, 6hours, 24 hours, 48 hours
Secondary Outcome Measure Information:
Title
Incidence of Delirium
Description
Incidence of Delirium
Time Frame
postop day 1,3,6
Title
Consumption of PCA
Description
The consumption of opioid.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Young Hwang, MD, phD
Phone
+82-10-2746-4750
Email
mistyblue15@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Young Hwang, MD,phD
Organizational Affiliation
Seoul Metropolitan Government Seoup National University Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27865707
Citation
Lefaucheur JP. A comprehensive database of published tDCS clinical trials (2005-2016). Neurophysiol Clin. 2016 Dec;46(6):319-398. doi: 10.1016/j.neucli.2016.10.002. Epub 2016 Nov 17.
Results Reference
background
PubMed Identifier
21470608
Citation
Borckardt JJ, Romagnuolo J, Reeves ST, Madan A, Frohman H, Beam W, George MS. Feasibility, safety, and effectiveness of transcranial direct current stimulation for decreasing post-ERCP pain: a randomized, sham-controlled, pilot study. Gastrointest Endosc. 2011 Jun;73(6):1158-64. doi: 10.1016/j.gie.2011.01.050. Epub 2011 Apr 5.
Results Reference
background
PubMed Identifier
23370085
Citation
Borckardt JJ, Reeves ST, Robinson SM, May JT, Epperson TI, Gunselman RJ, Schutte HD, Demos HA, Madan A, Fredrich S, George MS. Transcranial direct current stimulation (tDCS) reduces postsurgical opioid consumption in total knee arthroplasty (TKA). Clin J Pain. 2013 Nov;29(11):925-8. doi: 10.1097/AJP.0b013e31827e32be.
Results Reference
background

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Effectiveness of Transcranial Direct Current Stimulation for TKR

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