The purpose of this study is to evaluate the ability of Neuro-Stim System, a non-pharmacologic alternative for pain management, to reduce pain and treat insomnia. Neuro-Stim System uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system.
Pain is a complex problem that complicates recovery and rehabilitation after traumatic injury and surgery. The physician must balance pain management therapies against the potential for side effects and complications. Most of the treatment options for pain are pharmacological and have the potential for serious side effects and drug interactions. A non-pharmacological treatment would reduce the risk of adverse events and likely enhance the overall multimodal pain plan. The purpose of this study is to evaluate the effectiveness of Neuro-Stim System (NSS), a non-pharmacological option that uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system, to treat pain and improve sleep. Pain patients will be asked to participate in a study to evaluate the ability of Neuro-Stim System to reduce pain and to treat insomnia. NSS is a Federal Drug Administration (FDA) approved device intended to be used for chronic and acute pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
17
5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear.
(5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear.
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Pain Measured Via the Defense and Veterans Pain Scale v2.0 (DVPRS)
The primary outcome is pain measured by the Defense and Veterans Pain Rating Scale (DVPRS) from 0-10 at baseline, 15 minutes, and daily for 5 days after application. Rate the severity of your CURRENT pain: 0 - No Pain 1. \- Hardly notice pain 2. \- Notice pain, does not interfere with activities 3. \- Sometimes distracts me 4. \- Distracts me, can do usual activities 5. \- Interrupts some activities 6. \- Hard to ignore, avoid usual activities 7. \- Focus of attention, prevents doing daily activities 8. \- Awful, hard to do anything 9. \- Can't bear pain, unable to do anything 10. \- As bad as it could be, nothing else matters Higher values represent worse outcomes
Time frame: baseline to 5 days
Modified PROMIS for Pain Intensity
Use the scale to answer the following questions for Pain Intensity in the past 24 hours, 1=had no pain 2=Mild 3= Moderate 4= Severe 5=Very Severe 1. How intense was your pain at its worst? 2. How intense was your average pain? 3. What is your level of pain right now? Higher values represent worse outcomes
Time frame: baseline to 10 days
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