Dose Dependent Effects of tDCS on Post-Operative Pain
tDCS-TKA
2 other identifiers
interventional
119
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2014
CompletedFirst Posted
Study publicly available on registry
September 16, 2014
CompletedStudy Start
First participant enrolled
January 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2020
CompletedResults Posted
Study results publicly available
October 7, 2021
CompletedJuly 13, 2022
June 1, 2022
4.5 years
September 2, 2014
June 25, 2021
June 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Post-operative Opioid Pain Medication Dose
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
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 Outcomes (1)
Patient-reported Average Pain Ratings
6 Months
Study Arms (4)
tDCS Full Dose
EXPERIMENTAL4 active treatments
tDCS Half Dose
EXPERIMENTAL2 active treatments
tDCS Minimal dose
EXPERIMENTAL1 active treatment
Sham tDCS
SHAM COMPARATORno active treatments
Interventions
Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.
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.
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.
Four sessions of sham tDCS; control intervention.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Implanted medical devices above the waist
- Pregnant
- History of seizures
- Allergic to latex rubber
- Psychiatric conditions other than for depression and/or anxiety disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey Borckardt, Ph.D
- Organization
- Ralph H. Johnson VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey J Borckardt, PhD
Ralph H. Johnson VA Medical Center, Charleston, SC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2014
First Posted
September 16, 2014
Study Start
January 7, 2016
Primary Completion
July 2, 2020
Study Completion
July 2, 2020
Last Updated
July 13, 2022
Results First Posted
October 7, 2021
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share