A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 3)

Study Overview
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Brief Summary
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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
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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 Visual analogue scale (VAS). 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. Hear rate variability (HRV). It consists of 5-minute electrocardiogram (ECG) recording before and after a treatment session.

Official Title
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A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 3)

Conditions
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Pain Management

Intervention / Treatment
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* Device: BreEStim 240
* Device: EStim 240


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BreEStim<br>BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. | Device: BreEStim 240<br>* 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.<br>|
| Experimental: EStim<br>EStim is transcutaneous electrical nerve stimulation. | Device: EStim 240<br>* 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain as measured by the visual analog scale (VAS). Scores are recorded from 0 to10. | Scores are recorded from 0 to 10 with 0 being no pain and 10 being worst pain. | Baseline, after 10 intervention sessions, about 2 weeks | 
| Change in sensation measured by Electrical sensation detection threshold (EDT) | This is self-reported by the subjects as soon as they first sense the electrical current. | Baseline, after 10 intervention sessions, about 2 weeks | 
| Change in pain measured by Electrical pain detection threshold (EPT) | This is self-reported by the subjects at the first sensation of pain. | Baseline, after 10 intervention sessions, about 2 weeks | 
| 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. | Baseline, after 10 intervention sessions, about 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phantom Limb Pain, BreEStim