Trial Outcomes & Findings for Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use (NCT NCT02673684)
NCT ID: NCT02673684
Last Updated: 2020-05-27
Results Overview
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
TERMINATED
NA
17 participants
baseline to 5 days
2020-05-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Study not completed d/t loss of funding
|
9
|
8
|
Baseline Characteristics
Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use
Baseline characteristics by cohort
| Measure |
Sham NSS
n=9 Participants
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.
|
NSS (Working Device)
n=8 Participants
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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 5 daysPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 10 daysPopulation: 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.
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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 10 daysPopulation: No data analysis was done due to loss of funding in the early stages of project.
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?
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 10 daysPopulation: No data analysis was done due to loss of funding in the early stages of project.
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…
Outcome measures
Outcome data not reported
Adverse Events
Sham NSS
NSS (Working Device)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mary McDuffie
Defense and Veterans Center for Integrative Pain Management
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place