Dose Dependent Effects of tDCS on Post-Operative Pain (tDCS-TKA)
Primary Purpose
Total Knee Arthroplasty (Postoperative Pain), Total Hip Arthroplasty(Postoperative Pain)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
4 Real sessions of Transcranial Direct Current Stimulation
2 Real Sessions of Transcranial Direct Current Stimulation
1 Real Session of Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Total Knee Arthroplasty (Postoperative Pain) focused on measuring total knee arthroplasty, pain, post-surgical pain, opioid, transcranial direct current stimulation, tDCS, brain stimulation, total hip arthroplasty, TKA, THA
Eligibility Criteria
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
Sites / Locations
- Ralph H. Johnson VA Medical Center, Charleston, SC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
tDCS Full Dose
tDCS Half Dose
tDCS Minimal dose
Sham tDCS
Arm Description
4 active treatments
2 active treatments
1 active treatment
no active treatments
Outcomes
Primary Outcome Measures
Post-operative Opioid Pain Medication Dose
Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
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.
Secondary Outcome Measures
Patient-reported Average Pain Ratings
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."
Full Information
NCT ID
NCT02241967
First Posted
September 2, 2014
Last Updated
June 24, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02241967
Brief Title
Dose Dependent Effects of tDCS on Post-Operative Pain
Acronym
tDCS-TKA
Official Title
Dose Dependent Effects of tDCS on Post-Operative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2016 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty (Postoperative Pain), Total Hip Arthroplasty(Postoperative Pain)
Keywords
total knee arthroplasty, pain, post-surgical pain, opioid, transcranial direct current stimulation, tDCS, brain stimulation, total hip arthroplasty, TKA, THA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS Full Dose
Arm Type
Experimental
Arm Description
4 active treatments
Arm Title
tDCS Half Dose
Arm Type
Experimental
Arm Description
2 active treatments
Arm Title
tDCS Minimal dose
Arm Type
Experimental
Arm Description
1 active treatment
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
no active treatments
Intervention Type
Device
Intervention Name(s)
4 Real sessions of Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS Full Dose
Intervention Description
Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.
Intervention Type
Device
Intervention Name(s)
2 Real Sessions of Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS Half Dose
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
1 Real Session of Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS Minimal Dose
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Other Intervention Name(s)
Sham tDCS
Intervention Description
Four sessions of sham tDCS; control intervention.
Primary Outcome Measure Information:
Title
Post-operative Opioid Pain Medication Dose
Description
Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
Time Frame
2-Days
Title
Patient-reported Pain Intensity Ratings
Description
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.
Time Frame
2-Days
Secondary Outcome Measure Information:
Title
Patient-reported Average Pain Ratings
Description
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."
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey J Borckardt, PhD
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Dose Dependent Effects of tDCS on Post-Operative Pain
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