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

NCT ID: NCT02673684

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-05-01

Brief 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.

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.

Conditions

Pain (Visceral, Somatic, or Neuropathic)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham Neurostim System (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.

Group Type: SHAM_COMPARATOR

Sham NSS

Intervention Type: DEVICE

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

Working Neurostim System (Working 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.

Group Type: EXPERIMENTAL

Experimental NSS

Intervention Type: DEVICE

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

Interventions

Experimental NSS

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

Intervention Type: DEVICE

Sham NSS

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

Intervention Type: DEVICE

Other Intervention Names

Electro Auricular Device

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovative Health Solutions

INDUSTRY

Sponsor Role: collaborator

Defense and Veterans Center for Integrative Pain Management

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chester Buckenmaier, MD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

390805

Identifier Type: -

Identifier Source: org_study_id