Pain (Visceral, Somatic, or Neuropathic)NSSNCT02673684
Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use
A study testing Experimental NSS in people with Pain (Visceral, Somatic, or Neuropathic), run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain (Visceral, Somatic, or Neuropathic)
- What is being tested?
- Experimental NSS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 1 May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Double Blind, Randomized, Sham-Controlled Study on the Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use in Pain Patients
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.
Read the 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)
- Being tested
- Experimental NSS, Sham NSS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental NSSDevice
Also called Electro Auricular Device
5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear.
Sham NSSDevice
(5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear.
| Study group | Role | What they receive |
|---|---|---|
| Sham Neurostim System (Sham NSS) | Sham comparator | 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. Receives: Device: Sham NSS |
| Working Neurostim System (Working NSS) | Experimental | 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. Receives: Device: Experimental NSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to 5 days
Secondary outcomes (1)
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
Measured: baseline to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion1 May 2016
- Study completion1 May 2016
Why it stopped: Lost funding from sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain (Visceral, Somatic, or Neuropathic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Health Solutions
- Responsible party
- Sponsor
- Investigators
- Chester Buckenmaier, MD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673684
- Sponsor's protocol ID
- 390805
- Acronym
- NSS
- Status last verified
- May 2020
- First submitted
- 27 Jan 2016
- Last updated
- 27 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Sham-Controlled Study on the Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use in Pain Patients
- ClinicalTrials.gov ID
- NCT02673684
- Acronym / sponsor ID
- NSS / 390805
- Conditions
- Pain (Visceral, Somatic, or Neuropathic)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lost funding from sponsor
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Collaborators
- Innovative Health Solutions
- Study start
- Feb 2016
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 27 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Neurostim System (Sham NSS) | Sham comparator | Device: Sham NSSIn 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. |
| Working Neurostim System (Working NSS) | Experimental | Device: Experimental NSSIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental NSSAlso: Electro Auricular Device5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear. | Device | Working Neurostim System (Working NSS) |
| Sham NSS(5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear. | Device | Sham Neurostim System (Sham NSS) |
Primary outcome
Pain Measured Via the Defense and Veterans Pain Scale v2.0 (DVPRS)
Time frame: baseline to 5 days
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 1. - Hardly notice pain 2. - Notice pain, does not interfere with activities 3. - Sometimes distracts me 4. - Distracts me, can do usual activities 5. - Interrupts some activities 6. - Hard to ignore, avoid usual activities 7. - Focus of attention, prevents doing daily activities 8. - Awful, hard to do anything 9. - Can't bear pain, unable to do anything 10. - As bad as it could be, nothing else matters Higher values represent worse outcomes
1 secondary outcome
Modified PROMIS for Pain Intensity
Time frame: baseline to 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pain (Visceral, Somatic, or Neuropathic)
Recruiting
Post Operative Pain and Vagal Stimulation
Rectal Surgery, Pain (Visceral, Somatic, or Neuropathic)
Not yet recruiting
The Effect of Sound-Based Interventions on Pain and Anxiety in Pediatric Patients
Pain (Visceral, Somatic, or Neuropathic), Anxiety Acute
RecruitingPhase 2/3
Virtual Menstrual Pain Approaches in Females
Pain (Visceral, Somatic, or Neuropathic), Women of Reproductive Age
RecruitingObservational study
Characteristics of Persistent Pain Composition Following Total Hip or Knee Arthroplasty: a Descriptive Study
Pain (Visceral, Somatic, or Neuropathic), Hip Arthroplasty Replacement
Recruiting
Comparison of Conventional Buccal Nerve Block Versus Buccal Nerve Trunk Block During Extraction of Posterior Mandibular Teeth
Pain (Visceral, Somatic, or Neuropathic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chester Buckenmaier, MD principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental NSS in people with Pain (Visceral, Somatic, or Neuropathic), run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Measured Via the Defense and Veterans Pain Scale v2.0 (DVPRS) (time frame: baseline to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.