Dose Dependent Effects of tDCS on Post-Operative Pain
Condition: Total Knee Arthroplasty (Postoperative Pain); Total Hip Arthroplasty(Postoperative Pain)
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): 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
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 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.
Other intervention name(s): tDCS Full Dose; tDCS Half Dose; tDCS Minimal Dose; Sham tDCS
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; pain; post-surgical pain; opioid; transcranial direct current stimulation; tDCS; brain stimulation; total hip arthroplasty; TKA; THA