Dose Dependent Effects of tDCS on Post-Operative Pain

NCT ID: NCT02241967

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-07
• Study Completion Date: 2020-07-02

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.

Conditions

Total Knee Arthroplasty (Postoperative Pain); Total Hip Arthroplasty(Postoperative Pain)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

tDCS Full Dose

4 active treatments

Group Type: EXPERIMENTAL

4 Real sessions of Transcranial Direct Current Stimulation

Intervention Type: DEVICE

Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.

tDCS Half Dose

2 active treatments

Group Type: EXPERIMENTAL

2 Real Sessions of Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

tDCS Minimal dose

1 active treatment

Group Type: EXPERIMENTAL

1 Real Session of Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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 tDCS

no active treatments

Group Type: SHAM_COMPARATOR

Sham Transcranial Direct Current Stimulation

Intervention Type: DEVICE

Four sessions of sham tDCS; control intervention.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Sham Transcranial Direct Current Stimulation

Four sessions of sham tDCS; control intervention.

Intervention Type: DEVICE

Other Intervention Names

tDCS Full Dose; tDCS Half Dose; tDCS Minimal Dose; Sham tDCS

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey J Borckardt, PhD

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CX001078

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CLIN-005-13F

Identifier Type: -

Identifier Source: org_study_id