CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 119 enrolled
Drug / intervention
4 Real sessions of Transcranial Direct Current Stimulation +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02241967
NCT02241967Phase 1Completed

Dose Dependent Effects of tDCS on Post-Operative Pain

VA Office of Research and Development·interventional·Posted Sep 16, 2014·Updated Jul 13, 2022

In Brief

A Phase 1 clinical trial evaluating 4 Real sessions of Transcranial Direct Current Stimulation, 2 Real Sessions of Transcranial Direct Current Stimulation, and 2 other interventions for Total Knee Arthroplasty (Postoperative Pain) and Total Hip Arthroplasty(Postoperative Pain). Completed, enrolled 119 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 16, 2014
Enrollment StartJan 7, 2016
Primary CompletionJul 2, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.8 years ago

Interventions

4 Real sessions of Transcranial Direct Current Stimulationdevice

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 Transcranial Direct Current Stimulationdevice

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.

1 Real Session of Transcranial Direct Current Stimulationdevice

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.

Sham Transcranial Direct Current Stimulationdevice

Four sessions of sham tDCS; control intervention.