Effectiveness of Transcranial Direct Current Stimulation for TKR

Seoul National University

Status: Unknown

Conditions: Transcranial Direct Current Stimulation; Post Operative Pain

Treatments: Device: Sham tDCS; Device: apply tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03898245

2018/00/0000.0

Details and patient eligibility

About

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,

Enrollment: 70 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

active tDCS

Active Comparator group

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

Treatment:

Device: apply tDCS

sham tDCS

Sham Comparator group

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)

Treatment:

Device: Sham tDCS