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

• ClinicalTrials.gov Identifier: NCT02241967
• Recruitment Status: Active, not recruiting
• First Posted: September 16, 2014
• Last Update Posted: October 3, 2019
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

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.

Condition or disease	Intervention/treatment	Phase
Total Knee Arthroplasty (Postoperative Pain); Total Hip Arthroplasty(Postoperative Pain)	Device: Transcranial Direct Current Stimulation	Phase 1

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. 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Dose Dependent Effects of tDCS on Post-Operative Pain
• Actual Study Start Date: January 7, 2016
• Estimated Primary Completion Date: February 5, 2020
• Estimated Study Completion Date: February 5, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: tDCS Full Dose; 4 active treatments	Device: Transcranial Direct Current Stimulation; Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.; Other Name: tDCS
Experimental: tDCS Half Dose; 2 active treatments	Device: Transcranial Direct Current Stimulation; Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.; Other Name: tDCS
Experimental: tDCS Minimal dose; 1 active treatment	Device: Transcranial Direct Current Stimulation; Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.; Other Name: tDCS
Sham Comparator: Sham tDCS; no active treatments	Device: Transcranial Direct Current Stimulation; Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.; Other Name: tDCS

Outcome Measures

Primary Outcome Measures :

1. Post-operative opioid pain medication dose [ Time Frame: 3-Days ]
   Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.

Secondary Outcome Measures :

1. Patient-reported pain ratings [ Time Frame: 6 Months ]
   Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, South Carolina

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States, 29401-5799

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Jeffrey J Borckardt, PhD; Ralph H. Johnson VA Medical Center, Charleston, SC

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02241967 History of Changes
• Other Study ID Numbers: CLIN-005-13F; CX001078 ( Other Grant/Funding Number: Charleston CSR&D )
• First Posted: September 16, 2014
• Last Update Posted: October 3, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by VA Office of Research and Development:

total knee arthroplasty; pain; post-surgical pain; opioid; transcranial direct current stimulation; tDCS; brain stimulation; total hip arthroplasty; TKA; THA

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms