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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
The University of Texas Health Science Center
Houston, Texas, United States
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)
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)
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.
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Time frame: From Baseline to completion of 10 intervention sessions (about 2 weeks)