Effectiveness of Transcranial Direct Current Stimulation for TKR

NCT ID: NCT03898245

Last Updated: 2019-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-05-10

Brief Summary

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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,

Detailed Description

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Conditions

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Transcranial Direct Current Stimulation Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

apply tDCS

Intervention Type DEVICE

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 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)

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin-Young Hwang

Associate professor, Department of Anesthesiology and Pain medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Young Hwang, MD,phD

Role: PRINCIPAL_INVESTIGATOR

Seoul Metropolitan Government Seoup National University Boramae Medical Center

Locations

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Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Jin-Young Hwang, MD, phD

Role: CONTACT

+82-10-2746-4750

References

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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.

Reference Type BACKGROUND
PMID: 27865707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21470608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23370085 (View on PubMed)

Other Identifiers

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2018/00/0000.0

Identifier Type: -

Identifier Source: org_study_id

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