Authors: Beth Baughman DuPree, Jason Wesley, Estelle Farrell, Paul Lewis.
The aim of this IRB approved study was to evaluate the efficacy of the non-invasive, drug-free, re-usable patch, Signal ReliefTM, for the management of general musculoskeletal pain. Pain severity was assessed at baseline and upon completion of 7-day treatment schedule using Visual Analog Pain Scale (VAS), Brief Pain Inventory form (BPI) and Pain Interference Score (PIS). Reduction in pain medication use was evaluated via pain medication diary. An optional, exploratory endpoint of Substance P blood serum levels at baseline and end of treatment was also assessed. We enrolled 42 subjects with 2 board-certified physicians, one primary care and one a pain specialist. Thirty-two subjects completed the trial. Seventy five percent (24/32) subjects had a ≥ 30% reduction in pain on VAS. The average reduction in pain per VAS, BPI and PSI for the cohort was 59.7% (-65.6, -53.7); 44% (-53.1, -34.9); and 47.4% (-53.7, -41.1) respectively. Sixty eight percent (22/32) subjects were taking pain medication upon study entry. Reduction in pain medication use demonstrated was a 96.5% decrease for non-opioids and 91.4% decrease for opioids. Substance P levels were collected for 24 subjects. While 50% of subjects (12/24) showed a reduction in Substance P levels there was an overall increase of 11.7% across the entire cohort. Safety assessments included physical examination, monitoring of vital signs, and adverse event reporting per study visit schedule. No adverse events were reported. Our findings suggest that the Signal ReliefTM may be an effective non-invasive, drug-free option for the management of general musculoskeletal pain.
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