Pain (Visceral, Somatic, or Neuropathic)
Conditions
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.
Interventions
DEVICEExperimental NSS
5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear.
DEVICESham NSS
(5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear.
Sponsors
Innovative Health Solutions
Defense and Veterans Center for Integrative Pain Management
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measured Via the Defense and Veterans Pain Scale v2.0 (DVPRS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified PROMIS for Pain Intensity | baseline to 10 days | 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 1. How intense was your pain at its worst? 2. How intense was your average pain? 3. What is your level of pain right now? Higher values represent worse outcomes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Modified PROMIS for Pain Interference | baseline to 10 days | Use the following scale to to answer the questions about Pain Interference in the last 24 hours 1=Not at all 2=A little bit 3= Somewhat 4= Quite a bit 5=Very much 1. How much did pain interfere with your enjoyment of life? 2. How much did pain interfere with your ability to concentrate? 3. How much did pain interfere with your day to day activities? |
| Modified PROMIS for Sleep Disturbance | baseline to 10 days | Use the scale to answer the following question regarding Sleep Disturbance in the past 24 hours 1=Very Poor 2=Poor 3= Fair 4= Good 5=Very Good 1\. My sleep quality was... Use the scale to answer the following questions regarding Sleep Disturbance in the past 24 hours 1=Not at all 2=A little bit 3= Somewhat 4= Quite a bit 5=Very much 1. My sleep was refreshing… 2. I had a problem with my sleep… 3. I had difficulty falling asleep… |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Sham NSS: (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear. | 9 |
| NSS (Working Device) 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.
Experimental NSS: 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear. | 8 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study not completed d/t loss of funding | 9 | 8 |
Baseline characteristics
| Characteristic | Sham NSS | NSS (Working Device) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 |
Outcome results
Primary
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 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
Time frame: baseline to 5 days
Population: Sufficient data was not collected and the study was terminated. No data analysis was done due to loss of funding in the early stages of project.
Secondary
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 1. How intense was your pain at its worst? 2. How intense was your average pain? 3. What is your level of pain right now? Higher values represent worse outcomes
Time frame: baseline to 10 days
Population: Sufficient data was not collected and the study was terminated. No data analysis was done due to loss of funding in the early stages of project.
Other Pre-specified
Modified PROMIS for Pain Interference
Use the following scale to to answer the questions about Pain Interference in the last 24 hours 1=Not at all 2=A little bit 3= Somewhat 4= Quite a bit 5=Very much 1. How much did pain interfere with your enjoyment of life? 2. How much did pain interfere with your ability to concentrate? 3. How much did pain interfere with your day to day activities?
Time frame: baseline to 10 days
Population: No data analysis was done due to loss of funding in the early stages of project.
Other Pre-specified
Modified PROMIS for Sleep Disturbance
Use the scale to answer the following question regarding Sleep Disturbance in the past 24 hours 1=Very Poor 2=Poor 3= Fair 4= Good 5=Very Good 1\. My sleep quality was... Use the scale to answer the following questions regarding Sleep Disturbance in the past 24 hours 1=Not at all 2=A little bit 3= Somewhat 4= Quite a bit 5=Very much 1. My sleep was refreshing… 2. I had a problem with my sleep… 3. I had difficulty falling asleep…
Time frame: baseline to 10 days
Population: No data analysis was done due to loss of funding in the early stages of project.