Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use (NSS)
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|ClinicalTrials.gov Identifier: NCT02673684|
Recruitment Status : Terminated (Lost funding from sponsor)
First Posted : February 4, 2016
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain (Visceral, Somatic, or Neuropathic)||Device: Experimental NSS Device: Sham NSS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Double Blind, Randomized, Sham-Controlled Study on the Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use in Pain Patients|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||May 1, 2016|
|Actual Study Completion Date :||May 1, 2016|
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.
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673684
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator:||Chester Buckenmaier, MD||Uniformed Services University of the Health Sciences|