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Dose Dependent Effects of tDCS on Post-Operative Pain
Phase 1 trial testing 4 Real sessions of Transcranial Direct Current Stimulation in Total Knee Arthroplasty (Postoperative Pain) in 119 participants. Completed in 2 July 2020.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 119 |
| Start date | 7 January 2016 |
| Primary completion | 2 July 2020 |
| Estimated completion | 2 July 2020 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
Adults 19 to 90, any sex, with Total Knee Arthroplasty (Postoperative Pain) or Total Hip Arthroplasty(Postoperative Pain). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
| Group | Value | 95% CI |
|---|---|---|
| tDCS Full Dose | 26.99 | ± 2.99 |
| tDCS Half Dose | 31.12 | ± 3.73 |
| tDCS Minimal Dose | 28.65 | ± 31.12 |
| Sham tDCS | 33.15 | ± 5.60 |
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.
| Group | Value | 95% CI |
|---|---|---|
| tDCS Full Dose | 5.33 | ± .44 |
| tDCS Half Dose | 5.59 | ± .43 |
| tDCS Minimal Dose | 5.84 | ± .48 |
| Sham tDCS | 5.33 | ± .56 |
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."
| Group | Value | 95% CI |
|---|---|---|
| tDCS Full Dose | 3.06 | ± .46 |
| tDCS Half Dose | 3.45 | ± .72 |
| tDCS Minimal Dose | 3.77 | ± .74 |
| Sham tDCS | 4.89 | ± .59 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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