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

Defense and Veterans Center for Integrative Pain Management

Status: Terminated

Conditions: Pain (Visceral, Somatic, or Neuropathic)

Treatments: Device: Sham NSS; Device: Experimental NSS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02673684

390805

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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17 participants in 2 patient groups

Sham Neurostim System (Sham NSS)

Sham Comparator group

Description:

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.

Treatment:

Device: Sham NSS

Working Neurostim System (Working NSS)

Experimental group

Description:

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.

Treatment:

Device: Experimental NSS