Clinical trial NCT02673684: Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain (Visceral, Somatic, or Neuropathic)
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
Collaborators: name: Innovative Health Solutions
First posted: 2016-02-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Measured Via the Defense and Veterans Pain Scale v2.0 (DVPRS)
timeFrame: baseline to 5 days
Secondary outcomes:
measure: Modified PROMIS for Pain Intensity
timeFrame: baseline to 10 days
Other outcomes:
measure: Modified PROMIS for Pain Interference
timeFrame: baseline to 10 days
measure: Modified PROMIS for Sleep Disturbance
timeFrame: baseline to 10 days
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Chester Buckenmaier, MD
role: PRINCIPAL_INVESTIGATOR
References: