Effectiveness of Transcranial Direct Current Stimulation for TKR

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03898245
• Other study ID #: 2018/00/0000.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 10, 2020

Study information

• Verified date: March 2019
• Source: SMG-SNU Boramae Medical Center
• Contact: Jin-Young Hwang, MD, phD
• Phone: +82-10-2746-4750
• Email: mistyblue15[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 10, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain
• Transcranial Direct Current Stimulation

Intervention

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 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS score	the decrease of pain scale in postop state with Visual Analog Scale.	1hour, 6hours, 24 hours, 48 hours
Secondary	Incidence of Delirium	Incidence of Delirium	postop day 1,3,6
Secondary	Consumption of PCA	The consumption of opioid.	24 hours