Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02241967 |
| Other study ID # |
CLIN-005-13F |
| Secondary ID |
CX001078 |
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
January 7, 2016 |
| Est. completion date |
July 2, 2020 |
Study information
| Verified date |
June 2022 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The proper control of acute and chronic pain is one of the most important areas in health
care. Despite the profound advances in neuroscience over the past 20 years, the investigators
still largely use opiate narcotics, much as was done in the Civil War. Total knee
arthroplasty (TKA) is one of the most common orthopedic procedures performed 1. While knee
pain is often a complaint that precedes TKA, the procedure itself is associated with
considerable post-operative pain lasting days to weeks. Adequate postoperative pain control
is an important factor in determining recovery time and hospital length of stay. New
analgesic strategies are needed that can be used adjunctively to existing strategies with the
potential to reduce reliance on opioid analgesia. Several novel brain stimulation
technologies including transcranial magnetic stimulation (TMS) and transcranial direct
current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety
of pain conditions. Electricity has no metabolite or other residue, and can be delivered with
minimal discomfort and without problems associated with drug-drug interactions. In two
independent preliminary pilot studies, the Investigators have shown that tDCS can reduce
post-operative PCA use by as much as 46% while simultaneously reducing subjective pain
ratings. The present study aims to determine the effects of transcranial direct current
stimulation (tDCS) on post-operative pain, patient-controlled analgesia (PCA) use, and
post-surgical complications during the 48-hour post-operative period following total knee
arthroplasty.
Description:
The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the
effects of tDCS on pain among Veterans receiving unilateral total knee arthroplasty (TKA) and
unilateral total hip arthroplasty (THA). Further, this study will examine dose-dependency of
the tDCS analgesic effects. Each tDCS session delivered either 20 min of real or sham tDCS.
Real tDCS was administered at 2mA whereas sham tDCS delivered none.
120 patients undergoing TKA will be randomly assigned to one of four groups:Group 1 will have
4 sessions of real tDCS, Group 2 - 2 sessions of real tDCS (+ 2 sham-sessions), and Group 3 -
1 session of real tDCS (+ 3 sham-sessions). Group 4 is "Sham" tDCS, which does not involve
any real stimulation. The participants will receive 2 tDCS treatments on the day of their
surgery, and 2 tDCS treatments the day after their surgery.
