BreEStim in Managing Neuropathic Pain After Spinal Cord Injury (SCI)

A Randomized, Double-blind, Sham-controlled, Parallel-group Trial Designed to Evaluate the Efficacy of BreEStim in Managing Neuropathic Pain After Spinal Cord Injury (SCI)

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).

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