NCT02673684

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Defense and Veterans Center for Integrative Pain Management · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

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

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-02-04
• Last updated: 2020-05-27
• Results posted: 2020-05-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study