Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Double Blind, Randomized, Sham-Controlled Study on the Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use in Pain Patients

Conditions
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Pain (Visceral, Somatic, or Neuropathic)

Intervention / Treatment
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* Device: Experimental NSS
* Device: Sham NSS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be inpatients (at Walter Reed National Military Medical Center) at the time of study enrollment and study device placement. Any patient experiencing post-operative pain (visceral, somatic, or neuropathic) and has a pain score (measured via DVPRS v2.0) equal to or greater than 4 for at least 3 hours in the past 24 hours. Has an intact external ear where device can be placed The skin of the ear at placement site must be free of infection The participant cannot have been on regularly scheduled central acting opioids for more than 30 days continuously leading up to the initiation of the study. However, intermittent, breakthrough opioids are permissible, but the potential subject must have a current opioid prescription. The participant must have vital signs (HR/breathing/blood pressure) within normal limits. Able to understand English and verbalize their pain level. Exclusion Criteria: Have inconsistent vital signs (fluctuating, extremely low blood pressure, tachycardia, etc.) Wear any time of implanted electrical device such as a brain shunt, vagal stimulator, pace maker, spinal pain pump, etc. Pregnant (by results of preoperative Human Chorionic Gonadotropin or hCG urine or blood testing) Has a history of skin allergy to metals unwilling to voluntarily participate hemophilia Psoriasis vulgaris on ears

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Neurostim System (Sham NSS)<br>In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device. | Device: Sham NSS<br>* (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear.<br>|
| Experimental: Working Neurostim System (Working NSS)<br>In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device. | Device: Experimental NSS<br>* 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear.<br>* Other names: Electro Auricular Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 - Hardly notice pain - Notice pain, does not interfere with activities - Sometimes distracts me - Distracts me, can do usual activities - Interrupts some activities - Hard to ignore, avoid usual activities - Focus of attention, prevents doing daily activities - Awful, hard to do anything - Can't bear pain, unable to do anything - As bad as it could be, nothing else matters Higher values represent worse outcomes | baseline to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 How intense was your pain at its worst? How intense was your average pain? What is your level of pain right now? Higher values represent worse outcomes | baseline to 10 days |