Dose Dependent Effects of tDCS on Post-Operative Pain

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.

Conditions

• Total Knee Arthroplasty (Postoperative Pain)
• Total Hip Arthroplasty(Postoperative Pain)

Interventions

DEVICE

4 Real sessions of Transcranial Direct Current Stimulation

Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.

DEVICE

2 Real Sessions of Transcranial Direct Current Stimulation

Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 2 real sessions of tDCS and 2 sham.

DEVICE

1 Real Session of Transcranial Direct Current Stimulation

Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 1 real sessions of tDCS and 3 sham.

DEVICE

Sham Transcranial Direct Current Stimulation

Four sessions of sham tDCS; control intervention.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Jeffrey J Borckardt, PhD · Ralph H. Johnson VA Medical Center, Charleston, SC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

19 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-07

Primary Completion

2020-07-02

Completion

2020-07-02

Countries

• United States

Study Locations