Dose Dependent Effects of tDCS on Post-Operative Pain (tDCS-TKA)
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ClinicalTrials.gov Identifier: NCT02241967 |
Recruitment Status :
Completed
First Posted : September 16, 2014
Last Update Posted : July 7, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Total Knee Arthroplasty (Postoperative Pain) Total Hip Arthroplasty(Postoperative Pain) | Device: Transcranial Direct Current Stimulation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Dose Dependent Effects of tDCS on Post-Operative Pain |
Actual Study Start Date : | January 7, 2016 |
Actual Primary Completion Date : | July 2, 2020 |
Actual Study Completion Date : | July 2, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: tDCS Full Dose
4 active treatments
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Device: Transcranial Direct Current Stimulation
Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
Other Name: tDCS |
Experimental: tDCS Half Dose
2 active treatments
|
Device: Transcranial Direct Current Stimulation
Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
Other Name: tDCS |
Experimental: tDCS Minimal dose
1 active treatment
|
Device: Transcranial Direct Current Stimulation
Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
Other Name: tDCS |
Sham Comparator: Sham tDCS
no active treatments
|
Device: Transcranial Direct Current Stimulation
Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
Other Name: tDCS |
- Post-operative opioid pain medication dose [ Time Frame: 3-Days ]Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
- Patient-reported pain ratings [ Time Frame: 6 Months ]Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods

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Ages Eligible for Study: | 19 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants will be 120 patients undergoing TKA or THA surgery at the Ralph H. Johnson VAMC in Charleston SC.
- Between the ages of 19 and 90
- Mentally capable of reading, writing, giving consent, and following instructions
- Cleared for and scheduled for unilateral TKA or THA surgery
Exclusion Criteria:
- Implanted medical devices above the waist
- Pregnant
- History of seizures
- Allergic to latex rubber
- Psychiatric conditions other than for depression and/or anxiety disorders

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241967
United States, South Carolina | |
Ralph H. Johnson VA Medical Center, Charleston, SC | |
Charleston, South Carolina, United States, 29401-5799 |
Principal Investigator: | Jeffrey J Borckardt, PhD | Ralph H. Johnson VA Medical Center, Charleston, SC |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT02241967 |
Other Study ID Numbers: |
CLIN-005-13F CX001078 ( Other Grant/Funding Number: Charleston CSR&D ) |
First Posted: | September 16, 2014 Key Record Dates |
Last Update Posted: | July 7, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
total knee arthroplasty pain post-surgical pain opioid transcranial direct current stimulation |
tDCS brain stimulation total hip arthroplasty TKA THA |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |