Pain Management
Conditions
Keywords
Phantom Limb Pain, BreEStim
Brief summary
The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation.
Interventions
Sponsors
National Institute on Disability, Independent Living, and Rehabilitation Research
The University of Texas Health Science Center, Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* has phantom limb pain (PLP) after amputation of one limb, upper or lower limb; * has chronic pain, \>3 months; * is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)
Exclusion criteria
* currently adjusting oral pain medications for their PLP; * has pain, but not PLP (e.g., from inflammation at the incision wound of the residual limb); * has a pacemaker, or other metal and/or implanted devices; * has cognitive impairment from brain injury or are not able to follow commands, or to give consent; * has amputation in multiple limbs; * have asthma or other pulmonary diseases; * are not medically stable; * have preexisting psychiatric disorders; * alcohol or drug abuse; * have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Level as Measured by the Visual Analog Scale (VAS). | Baseline, 10 minutes after intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST) | Baseline, 5 minutes after intervention | Electrical 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. |
| Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Threshold (EPT) | Baseline, 5 minutes after intervention | An 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference in Heart Rate Variability (HRV) Measured by Electrocardiogram (ECG) | Baseline, 10 minutes after intervention | HRV is a measure of the variation in time between each heartbeat. We use HRV to identify the autonomic nervous system changes after intervention treatment. A 5-minute HRV will be recorded prior to the intervention, and 10 mins after the intervention. In this study, the major HRV outcome measurement parameters we choose include: SDNN (standard deviation of normal-to-normal intervals), RMSSD (root mean square of successive differences), and pNN50 (percentage of adjacent RR intervals differing by more than 50ms). SDNN represents the overall variability in the time intervals between heartbeats, providing a general measure of autonomic nervous system function. RMSSD primarily reflects short-term variations in heart rate, often considered a good indicator of parasympathetic activity. pNN50 Measures the proportion of consecutive heartbeats with a significant difference in interval, reflecting the instantaneous changes in heart rate and parasympathetic activity and modulation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BreEStim 120, Then EStim 120 BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
BreEStim: 120 BreEStim stimuli will applied for about 10-30 minutes.
EStim: 120 EStim stimuli will applied for about 10-30 minutes. | 15 |
| EStim 120, Then BreEStim 120 BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
BreEStim: 120 BreEStim stimuli will applied for about 10-30 minutes.
EStim: 120 EStim stimuli will applied for about 10-30 minutes. | 0 |
| Total | 15 |
Baseline characteristics
| Characteristic | Total | BreEStim 120, Then EStim 120 |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 13 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Others | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 6 Participants | 6 Participants |
| Region of Enrollment United States | 15 participants | 15 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 15 / 15 | 15 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Pain Level as Measured by the Visual Analog Scale (VAS).
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
Time frame: Baseline, 10 minutes after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BreEStim 120 | Change in Pain Level as Measured by the Visual Analog Scale (VAS). | 1.38 score on a scale | Standard Deviation 1.24 |
| EStim 120 | Change in Pain Level as Measured by the Visual Analog Scale (VAS). | 1.27 score on a scale | Standard Deviation 1.13 |
Secondary
Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Threshold (EPT)
An 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.
Time frame: Baseline, 5 minutes after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BreEStim 120 | Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Threshold (EPT) | 3.99 milliampere (mA) | Standard Deviation 19.18 |
| EStim 120 | Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Threshold (EPT) | 3.39 milliampere (mA) | Standard Deviation 7.14 |
Secondary
Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST)
Electrical 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.
Time frame: Baseline, 5 minutes after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BreEStim 120 | Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST) | 1.00 milliampere (mA) | Standard Deviation 4.34 |
| EStim 120 | Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST) | 0.44 milliampere (mA) | Standard Deviation 2.58 |
Other Pre-specified
Difference in Heart Rate Variability (HRV) Measured by Electrocardiogram (ECG)
HRV is a measure of the variation in time between each heartbeat. We use HRV to identify the autonomic nervous system changes after intervention treatment. A 5-minute HRV will be recorded prior to the intervention, and 10 mins after the intervention. In this study, the major HRV outcome measurement parameters we choose include: SDNN (standard deviation of normal-to-normal intervals), RMSSD (root mean square of successive differences), and pNN50 (percentage of adjacent RR intervals differing by more than 50ms). SDNN represents the overall variability in the time intervals between heartbeats, providing a general measure of autonomic nervous system function. RMSSD primarily reflects short-term variations in heart rate, often considered a good indicator of parasympathetic activity. pNN50 Measures the proportion of consecutive heartbeats with a significant difference in interval, reflecting the instantaneous changes in heart rate and parasympathetic activity and modulation.
Time frame: Baseline, 10 minutes after intervention