The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and sham BreEStim and Transcutaneous Electrical Nerve Stimulation (TENS) in management of neuropathic pain in patients after spinal cord injury (SCI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
During the Active BreEStim Treatment session, participants will remain relaxed while breathing is monitored using a nasal cannula. Surface electrodes will be placed over the median nerve at the wrist or another selected peripheral nerve. Electrical stimulation will be synchronized with voluntary breathing and delivered at an individually tolerated intensity for approximately 30 minutes.
During the Sham BreEStim Treatment session, participants will remain relaxed while breathing is monitored using a nasal cannula. Surface electrodes will be placed over the median nerve at the wrist or another selected peripheral nerve. Electrical stimulation will be synchronized with voluntary breathing and delivered at the sensory threshold level for approximately 30 minutes.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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. Mean VAS difference will be compared.
Time frame: Baseline, 10-15 minutes after intervention
the difference in the percentage of responders between active BreEStim and Sham BreEStim groups
Given sham-controlled design, the investigators define responders as individual participants who achieve at least a 30% reduction in pain from their individual baseline scores.
Time frame: Baseline, 10-15 minutes after intervention
the difference in the percentage of responders between between active BreEStim and transcutaneous electrical nerve stimulation (TENS) groups.
Given sham-controlled design, the investigators define responders as individual participants who achieve at least a 30% reduction in pain from their individual baseline scores.
Time frame: Baseline, 10-15 minutes after intervention
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During the TENS Treatment session, participants will remain relaxed while transcutaneous electrical stimulation is applied through surface electrodes placed over the painful area. Stimulation will be delivered at an individually tolerated intensity for approximately 30 minutes.