Trial Outcomes & Findings for A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2) (NCT NCT04750538)
NCT ID: NCT04750538
Last Updated: 2025-03-20
Results Overview
VAS Scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. Change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after intervention)\] - a positive value indicates that the score (and pain level) decreased
COMPLETED
NA
17 participants
Baseline, 10 minutes after intervention
2025-03-20
Participant Flow
Participant milestones
| Measure |
BreEStim 120, Then BreEStim 240
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes.
BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes.
|
BreEStim 240, Then BreEStim 120
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes.
BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes.
|
|---|---|---|
|
First Intervention (10-15 Minutes)
STARTED
|
17
|
0
|
|
First Intervention (10-15 Minutes)
COMPLETED
|
17
|
0
|
|
First Intervention (10-15 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Washout (About 1-17 Days)
STARTED
|
17
|
0
|
|
Washout (About 1-17 Days)
COMPLETED
|
17
|
0
|
|
Washout (About 1-17 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (20-30 Minutes)
STARTED
|
17
|
0
|
|
Second Intervention (20-30 Minutes)
COMPLETED
|
17
|
0
|
|
Second Intervention (20-30 Minutes)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2)
Baseline characteristics by cohort
| Measure |
BreEStim 120, Then BreEStim 240
n=17 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes.
BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes.
|
BreEStim 240, Then BreEStim 120
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes.
BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
—
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
—
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
—
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
—
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
8 Participants
n=99 Participants
|
—
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=99 Participants
|
—
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Others
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
—
|
17 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 10 minutes after interventionVAS Scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. Change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after intervention)\] - a positive value indicates that the score (and pain level) decreased
Outcome measures
| Measure |
BreEStim 120
n=17 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes.
|
BreEStim 240
n=17 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes.
|
|---|---|---|
|
Change in Pain Level as Measured by the Visual Analog Scale (VAS).
|
1.43 score on a scale
Standard Deviation 1.24
|
1.71 score on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline, 5 minutes after interventionElectrical Sensation Threshold (EST) is the minimum electrical current intensity that a person can reliably perceive as a sensation on their skin. This threshold is self-reported by the subjects, and electrical intensity values are recorded when participants first detect the electrical stimulation. Change is reported as \[(EST at 5 minutes after intervention) - (EST at baseline)\] - a positive value indicates a decrease in sensation perception.
Outcome measures
| Measure |
BreEStim 120
n=17 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes.
|
BreEStim 240
n=17 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes.
|
|---|---|---|
|
Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST)
|
0.95 milliampere (mA)
Standard Deviation 4.06
|
3.43 milliampere (mA)
Standard Deviation 11.57
|
SECONDARY outcome
Timeframe: Baseline, 5 minutes after interventionAn Electrical Pain Threshold (EPT) refers to the minimum intensity of electrical stimulation required to produce a perceptible pain sensation on a person's skin, essentially measuring the point at which an electrical current becomes painful. The EPT is self-reported by subjects when they feel the electrical intensity begins to cause pain. Change is reported as \[(EPT at 5 minutes after intervention) - (EPT at baseline)\] - a positive value indicates an increase in pain threshold.
Outcome measures
| Measure |
BreEStim 120
n=17 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes.
|
BreEStim 240
n=17 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes.
|
|---|---|---|
|
Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT)
|
3.92 milliampere (mA)
Standard Deviation 17.97
|
2.29 milliampere (mA)
Standard Deviation 10.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 10 minutes after interventionHRV is a measure of the variation in time between each heartbeat. We use HRV to identify the autonomic nervous system changes after intervention treatment.
Outcome measures
Outcome data not reported
Adverse Events
BreEStim 120
BreEStim 240
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BreEStim 120
n=17 participants at risk
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes.
|
BreEStim 240
n=17 participants at risk
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Redness
|
23.5%
4/17 • 3 weeks
|
23.5%
4/17 • 3 weeks
|
|
General disorders
Discomfort
|
100.0%
17/17 • 3 weeks
|
100.0%
17/17 • 3 weeks
|
Additional Information
Sheng Li, MD, PhD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place