Pain Management
Conditions
Keywords
neuropathic pain, BreEStim
Brief summary
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).
Interventions
DEVICEActive BreEStim Treatment
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.
DEVICESham BreEStim Treatment
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.
DEVICEThe TENS Treatment
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.
Sponsors
The University of Texas Health Science Center, Houston
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Able to tolerate BreEStim treatment for 1 minute
Exclusion criteria
* 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 * has a pacemaker to avoid possible side effect of electrical stimulation * is not able to follow commands, or to give consent * has asthma or other pulmonary disease * has a history of cardiac pathology, implanted pacemakers, or current use of rhythm altering medication like beta-blockers * has baclofen pump or deep brain implants * has respiratory tract/sinus infection and rhinorrhea * has low motor neuron injury that no responses will be triggered by electrical stimulation * has severe mental disorders (e.g., depression, substance abuse) and is receiving active treatment and frequent monitoring * is not medically stable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Level as Measured by the Visual Analog Scale (VAS). | Baseline, 10-15 minutes after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the difference in the percentage of responders between active BreEStim and Sham BreEStim groups | Baseline, 10-15 minutes after intervention | 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. | Baseline, 10-15 minutes after intervention | 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. |
Countries
United States
Contacts
CONTACTSheng Li, MD, PhD
CONTACTShengai Li, MS
PRINCIPAL_INVESTIGATORSheng Li, MD, PhD
The University of Texas Health Science Center, Houston
Outcome results
None listed