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

Purpose

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.

Condition	Intervention
Pain (Visceral, Somatic, or Neuropathic)	Device: Experimental NSS Device: Sham NSS


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator Primary Purpose: Treatment
Official Title:	Double Blind, Randomized, Sham-Controlled Study on the Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use in Pain Patients

Further study details as provided by Defense and Veterans Center for Integrative Pain Management:

Primary Outcome Measures:

Pain Measured via the Defense and Veterans Pain Scale v2.0 (DVPRS) [ Time Frame: baseline to 5 days ]
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. Data will be analyzed using repeated measures analysis of variance (RM-ANOVA) and results will be confirmed by examining each time point using the Wilcoxon rank sum test. Data for question 2 on the DVPRS regarding the effect of pain on sleep (on a scale of 0-10) will be analyzed similarly.

Secondary Outcome Measures:

Modified PROMIS for pain, pain interference, and sleep [ Time Frame: baseline to 10 days ]
Determine if sleep scores improve in patients treated with NSS.
Opioid Use [ Time Frame: baseline to 10 days ]
Morphine equivalent of opioids used by subjects will be calculated and compared between groups.


Enrollment:	11
Study Start Date:	February 2016
Study Completion Date:	May 1, 2016
Primary Completion Date:	May 1, 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Comparator: Sham NSS 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 (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear.
Experimental: NSS 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 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear. Other Name: Electro Auricular Device

Arms

Assigned Interventions

Sham Comparator: Sham NSS

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

(5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear.

Experimental: NSS

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

5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear.

Other Name: Electro Auricular Device

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02673684

Locations


United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889

Sponsors and Collaborators

Defense and Veterans Center for Integrative Pain Management

Innovative Health Solutions

Investigators


Principal Investigator:	Chester Buckenmaier, MD	Uniformed Services University of the Health Sciences

More Information


Responsible Party:	Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier:	NCT02673684 History of Changes
Other Study ID Numbers:	390805
Study First Received:	January 27, 2016
Last Updated:	February 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No

Additional relevant MeSH terms:


Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs	Analgesics Sensory System Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 14, 2017

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