Dose Dependent Effects of tDCS on Post-Operative Pain (tDCS-TKA)

June 24, 2022 updated by: VA Office of Research and Development
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS Full Dose
4 active treatments
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.
Other Names:
  • tDCS Full Dose
Experimental: tDCS Half Dose
2 active treatments
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.
Other Names:
  • tDCS Half Dose
Experimental: tDCS Minimal dose
1 active treatment
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.
Other Names:
  • tDCS Minimal Dose
Sham Comparator: Sham tDCS
no active treatments
Device: Sham Transcranial Direct Current Stimulation
Four sessions of sham tDCS; control intervention.
Other Names:
  • Sham tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Opioid Pain Medication Dose
Time Frame: 2-Days
Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
2-Days
Patient-reported Pain Intensity Ratings
Time Frame: 2-Days
Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of "0- no pain at all" to maximum of "10- worst pain imaginable." Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.
2-Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported Average Pain Ratings
Time Frame: 6 Months
Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: "0- no pain," "10-worst pain imaginable."
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2016

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-005-13F
  • CX001078 (Other Grant/Funding Number: Charleston CSR&D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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