Phase 1
N=119
Dose Dependent Effects of tDCS on Post-Operative Pain
Total Knee Arthroplasty (Postoperative Pain) · Total Hip Arthroplasty(Postoperative Pain)
Bottom Line
View on ClinicalTrials.gov: NCT02241967 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Post-operative Opioid Pain Medication Dose — 26.99; 31.12; 28.65; 33.15 mg of morphine equivalent dose (MED)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 4 Real sessions of Transcranial Direct Current Stimulation (Device); 2 Real Sessions of Transcranial Direct Current Stimulation (Device); 1 Real Session of Transcranial Direct Current Stimulation (Device); Sham Transcranial Direct Current Stimulation (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Opioid Pain Medication Dose |
26.99; 31.12; 28.65; 33.15 | — |
| PRIMARY Patient-reported Pain Intensity Ratings |
5.33; 5.59; 5.84; 5.33 | — |
| SECONDARY Patient-reported Average Pain Ratings |
3.06; 3.45; 3.77; 4.89 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02241967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.