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).
has a history of SCI > 1 year
has a DN4 (Douleur Neuropathique en 4 Questions) score of 4 or greater
has neuropathic pain >3 months
is stable on oral pain medications at least one month
is on a mechanical ventilator
is currently having active urinary tract infection (UTI)
does not have any residual sensation in the arms
has other pain (musculoskeletal, visceral etc.), but not neuropathic, e.g., shoulder pain from wheelchair use
Parallel
Active BreEStim Treatment
DeviceDuring 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.
Sham BreEStim Treatment
DeviceDuring 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 TENS Treatment
DeviceDuring 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.
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.
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.
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.
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The University of Texas Health Science Center, Houston
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
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