Effectiveness of Transcranial Direct Current Stimulation for TKR

Not Applicable

• Conditions: Post Operative Pain; Transcranial Direct Current Stimulation
• Interventions: Device: Sham tDCS; Device: apply tDCS

• Registration Number: NCT03898245
• Lead Sponsor: 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,

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-03-29
• Last Update Submitted: 2019-03-29
• Study First Posted: 2019-04-01
• Last Update Posted: 2019-04-01
• Study Start: 2019-05-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham tDCS	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)
active tDCS	apply 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

Primary Outcome Measures

Name	Time	Method
VAS score	1hour, 6hours, 24 hours, 48 hours	the decrease of pain scale in postop state with Visual Analog Scale.

Secondary Outcome Measures

Name	Time	Method
Incidence of Delirium	postop day 1,3,6	Incidence of Delirium
Consumption of PCA	24 hours	The consumption of opioid.

Trial Locations

Locations (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of