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

Pain (Visceral, Somatic, or Neuropathic) Clinical Trial

— NSS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02673684
• Other study ID #: 390805
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 1, 2016

Study information

• Verified date: May 2020
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 1, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain (Visceral, Somatic, or Neuropathic)

Intervention

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

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management	Innovative Health Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified PROMIS for Pain Interference	Use the following scale to to answer the questions about Pain Interference in the last 24 hours; 1=Not at all 2=A little bit 3= Somewhat 4= Quite a bit 5=Very much; How much did pain interfere with your enjoyment of life?; How much did pain interfere with your ability to concentrate?; How much did pain interfere with your day to day activities?	baseline to 10 days
Other	Modified PROMIS for Sleep Disturbance	Use the scale to answer the following question regarding Sleep Disturbance in the past 24 hours; 1=Very Poor 2=Poor 3= Fair 4= Good 5=Very Good; 1. My sleep quality was...; Use the scale to answer the following questions regarding Sleep Disturbance in the past 24 hours; 1=Not at all 2=A little bit 3= Somewhat 4= Quite a bit 5=Very much; My sleep was refreshing…; I had a problem with my sleep…; I had difficulty falling asleep…	baseline to 10 days
Primary	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	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