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, we 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. While knee pain is often a complaint that precedes TKA, the procedure itself is associated with considerable post-operative pain lasting days to weeks, and adequate postoperative pain control is an important factor in determining recovery time, hospital length of stay, and long-term surgical outcomes. Primary methods used to manage post-operative pain primarily involve systemic opiates. Despite available strategies, patients still report considerable post-operative pain, and often struggle to complete post-operative physical therapy regimens. Additionally, systemic opiates have associated side-effects that can lead to post-operative complications including but not limited to mental-clouding, confusion, addiction, respiratory depression, interactions with other medications, and fatigue. These are not trivial concerns as the population receiving TKA are more and more likely to be elderly and/or overweight and thus these complications can have serious negative consequences. 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 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 preliminary studies, the investigators have found that tDCS can reduce post-operative PCA use by as much as 46% in TKA patients while simultaneously reducing subjective pain ratings. These findings are promising, but this new technology is in its infancy, and a foundation of well-controlled, high-quality clinical trials needs to be established before this field moves forward. The proposed study will be the first randomized, double-blind, sham-controlled clinical trial of the effects of tDCS on subjective pain-ratings, PCA opioid usage, and post- operative complications among veterans receiving unilateral TKA surgery. Further, this study will examine the relative efficacy of 3 different tDCS dosing strategies compared to sham stimulation. Data from this trial will likely yield information regarding the feasibility and efficacy of tDCS as a post-operative pain-management approach. If the proposed pilot trial suggests significant and meaningful effects of tDCS as an adjunctive post- operative pain management strategy, this could change the way post-operative pain management is approached in the future.

Public Health Relevance

The proper control of acute and chronic pain is one of the most important areas in health care. Several brain stimulation technologies including transcranial direct current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety of pain conditions. This study will be the first randomized, double-blind trial of tDCS technology as an adjunctive pain management strategy for post-operative pain in veterans.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
5I01CX001078-04
Application #
9428412
Study Section
Clinical Trials (CLIN)
Project Start
2014-10-01
Project End
2019-09-30
Budget Start
2017-10-01
Budget End
2018-09-30
Support Year
4
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Ralph H Johnson VA Medical Center
Department
Type
DUNS #
039807318
City
Charleston
State
SC
Country
United States
Zip Code
29401