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

This study has been terminated.
(Lost funding from sponsor)
Sponsor:
Collaborator:
Innovative Health Solutions
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier:
NCT02673684
First received: January 27, 2016
Last updated: February 7, 2017
Last verified: February 2017
History of Changes
January 27, 2016
February 7, 2017
February 2016
May 1, 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02673684 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use
Double Blind, Randomized, Sham-Controlled Study on the Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use in Pain Patients
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Pain (Visceral, Somatic, or Neuropathic)
  • 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
  • Device: Sham NSS
    (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear.
  • 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.
    Intervention: Device: Sham NSS
  • 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.
    Intervention: Device: Experimental NSS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
May 1, 2016
May 1, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02673684
390805
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
Plan to Share IPD: No
Defense and Veterans Center for Integrative Pain Management
Defense and Veterans Center for Integrative Pain Management
Innovative Health Solutions
Principal Investigator: Chester Buckenmaier, MD Uniformed Services University of the Health Sciences
Defense and Veterans Center for Integrative Pain Management
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP