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 after multiple sessions of treatment.
Detailed description
Subjects will receive 10-session BreEStim and 10-session EStim treatment in a random order. The interval between BreEStim and EStim is at least 2 weeks. The following assessment will be made before and after 1. Visual analogue scale (VAS). 2. Quantitative sensory testing (QST). It includes non-invasive assessment of tactile sensation threshold (TST), electrical sensation threshold (EST), electrical pain threshold (EPT), and thermal thresholds. 3. Hear rate variability (HRV). It consists of 5-minute electrocardiogram (ECG) recording before and after a treatment session.
Interventions
DEVICEBreEStim 240
240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
DEVICEEStim 240
240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
Sponsors
National Institute on Disability, Independent Living, and Rehabilitation Research
The University of Texas Health Science Center, Houston
Study design
Allocation
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 |
|---|---|---|
| Average Change in Pain as Measured by the Visual Analog Scale (VAS) | From Baseline to completion of 10 intervention sessions (about 2 weeks) | 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. For each session change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after each intervention)\] - a positive value indicates that the score (and pain level) decreased. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection Threshold (EST) | From Baseline to completion of 10 intervention sessions (about 2 weeks) | 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. For each session change is reported is reported as \[(EST at 5 minutes after intervention) - (EST at baseline)\] - a positive value indicates a decrease in sensation perception. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10. |
| Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT) | From Baseline to completion of 10 intervention sessions (about 2 weeks) | 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. For each session change is reported as \[(EPT at 5 minutes after intervention) - (EPT at baseline)\] - a positive value indicates an increase in pain threshold. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability (HRV) Measured by Electrocardiogram (ECG) | Baseline, after 10 intervention sessions, about 2 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BreEStim 240, Then EStim 240 BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.
BreEStim 240: 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. | 9 |
| EStim 240, Then BreEstim 240 EStim is transcutaneous electrical nerve stimulation.
BreEStim 240: 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | EStim 240, Then BreEstim 240 | BreEStim 240, Then EStim 240 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 9 Participants | 14 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Others | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 11 / 11 | 11 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Average Change in Pain 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. For each session change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after each intervention)\] - a positive value indicates that the score (and pain level) decreased. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.
Time frame: From Baseline to completion of 10 intervention sessions (about 2 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BreEStim 240 | Average Change in Pain as Measured by the Visual Analog Scale (VAS) | 1.38 score on a scale | Standard Deviation 0.69 |
| EStim 240 | Average Change in Pain as Measured by the Visual Analog Scale (VAS) | 0.93 score on a scale | Standard Deviation 0.43 |
Secondary
Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection 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. For each session change is reported as \[(EPT at 5 minutes after intervention) - (EPT at baseline)\] - a positive value indicates an increase in pain threshold. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.
Time frame: From Baseline to completion of 10 intervention sessions (about 2 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BreEStim 240 | Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT) | 3.69 mA | Standard Deviation 3.87 |
| EStim 240 | Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT) | 0.99 mA | Standard Deviation 1.51 |
Secondary
Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection 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. For each session change is reported is reported as \[(EST at 5 minutes after intervention) - (EST at baseline)\] - a positive value indicates a decrease in sensation perception. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.
Time frame: From Baseline to completion of 10 intervention sessions (about 2 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BreEStim 240 | Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection Threshold (EST) | -0.22 mA | Standard Deviation 0.27 |
| EStim 240 | Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection Threshold (EST) | -0.11 mA | Standard Deviation 0.37 |
Other Pre-specified
Change 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.
Time frame: Baseline, after 10 intervention sessions, about 2 weeks