Abstract
BACKGROUND: Neuropathic Pain (NP) affects 10% of the general population, decreasing quality of life for millions of Americans and contributing to higher physical and mental health care costs. The most widely used treatments for NP involve medications that show limitations in efficacy and burdensome side effects. METHODS: This randomized controlled trial explored the efficacy of a wearable Audio-Visual Stimulation neuromodulation device (Sana) as a novel intervention for chronic NP in 75 participants. Outcomes were assessed at baseline, after 8-weeks of daily use of the assigned Sana or Sham device, and after 4 weeks of discontinued use. RESULTS: For the main outcome (Neuropathic Pain Symptom Inventory total), there were statistically significant improvements in the Active arm that were greater than those in the Sham Arm at Week-14 (Mean Difference = 8.75, p = 0.021). Both groups showed significant improvements at the end of the treatment period (Week-10), and the Active arm maintained this improvement after an additional 4 weeks of non-use, while the Sham arm almost returned to baseline (Active Change = 11.7, p < = 0.001 | Sham Change = 3, p = 0.24). Participants in the Active arm had significant decreases in use of anxiolytic, opiate, antidepressant, and anticonvulsant medications compared to the Sham arm. CONCLUSIONS: The study provides strong evidence supporting the efficacy of a novel AVS Device in generating durable improvements in NP, with superiority over Sham at 14 weeks. The Sana device may also reduce the reliance on pain medications and is a safe and easy to use treatment option for patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04280562. Date of first enrolment was 1/31/2020 and the trial was retrospectively registered on clinicaltrials.gov on 2/20/2020. This minor delay was due to administrative and pandemic-related disruptions and is less than the 21 days allowed between trial registration and the first participant being enrolled in compliance with the FDAAA 801 regulations. Despite the delayed registration, the trial was conducted in a prospective manner with trail design, protocol, and endpoints finalized well before enrolment with full compliance with the Program for the Protection of Human Subjects (PHHS) at the Icahn School of Medicine at Mount Sinai (ISMMS), and without intention of selective reporting. In addition, IRB approval in 2018 and 2019 for documents including the protocol and consent form, without any modification after the enrolment of the first participant, further support that the clinical trial was conducted prospectively.