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NCT02241967 · ClinicalTrials.gov registry record · Phase 1
Dose Dependent Effects of tDCS on Post-Operative Pain
A Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
NCT02241967: Completed Phase 1 study, sponsored by VA Office of Research and Development.
NCT02241967 is a Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 119 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02241967, a Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
Study 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.
Primary Outcome
Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
Interventions
- DEVICE Sham Transcranial Direct Current Stimulation
- DEVICE 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2016-01-07 |
| Est. Completion | 2020-07-02 |
| Phase | Phase 1 |
What the finished NCT02241967 record still lists
NCT02241967 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 4 interventions - of which Sham Transcranial Direct Current Stimulation is the first listed.
NCT02241967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02241967 about?
NCT02241967 is a clinical study titled "Dose Dependent Effects of tDCS on Post-Operative Pain". 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 m...
What is the current status of trial NCT02241967?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2016-01-07. Estimated completion is 2020-07-02.
What interventions are being tested in trial NCT02241967?
The interventions under investigation include: Sham Transcranial Direct Current Stimulation (DEVICE), 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).
Who is sponsoring clinical trial NCT02241967?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02241967's enrollment target sits among peer trials
119 498th of 2000 higher than 1,502 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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