Project Summary The goal of this project is to develop a multimodal neuromodulatory opioid-sparing device for low back pain, demonstrate effective pain relief, then evaluate opioid reduction for patients with acute or chronic back pain presenting for treatment. Pain and opioid use disorder (OUD) are intricately related: dependence begins for up to 80% with medications prescribed for pain, either directly or through pills left in circulation. Currently, there is no proven approach to help reduce long-term opioid use for patients with chronic non-cancer pain. What is known is that prescriptions of opioids for acute low back pain are a factor in eventual OUD, and unused opioids in circulation are increasingly abused for non-medical reasons. For the already dependent with chronic pain, one barrier to reduction is fear of ongoing or increasing pain. An effective non-pharmaceutical pain reliever could reduce home opioid prescriptions for acute pain, and aid chronic pain patients seeking to wean. Acute and chronic low back pain are among the most common sources of short and long term disability. Opioids are commonly prescribed, but no better than non- addictive solutions for chronic low back pain. Neuromodulation (cold, high frequency vibration, low frequency whole body vibration, acupressure), heat, and support are effective for many, but no current device combines these multiple modalities of pain relief. One recent study found a surgically placed neuromodulatory device significantly decreased opioid use for patients with chronic low back pain. Low back pain would be the most impactful clinical scenario in which to test an external multi-modal neuromodulatory pain reliever for its impact on initial and chronic opioid use. Patients with chronic pain report benefitting from multiple pain relief strategies over time. Because having options improves the perception of control, the ideal pain relief device would incorporate multiple pain relieving modalities to reduce catastrophizing. To relieve sharp pain, we created an NICHD-funded “Buzzy” neuromodulatory device combining high frequency vibration and ice, now proven effective in over 28 independent clinical trials. To address low back pain, our “DuoTherm” device incorporates the Buzzy frequency, cold, heat, acupressure, and two additional frequencies. Preliminary data from 32 subjects demonstrated substantial and sustained pain reduction, distinct preferences for vibration frequencies, and strong commercial desire for the product. This project will develop and clinically evaluate DuoTherm, an innovative opioid-sparing therapeutic. This patient-controlled external neuromodulation device will be designed to address acute and chronic LBP. After validating effective pain relief with DuoTherm compared to placebo, we will test whether an effective low back pain relief device reduces opioid use for acute and chronic low back pain patients.

Project Narrative The goal of this project is to develop an opioid-sparing therapeutic consumer device for low back pain, with multiple patient-controlled effective neuromodulatory pain relief options including vibration, pressure, cold and heat. Fear of pain and disability, or “catastrophizing”, increases opioid use, but is reduced when patients have effective options and feel control over pain. After proving that providing a multimodal device is effective for pain, the project will determine whether the availability of an effective home therapy device reduces opioid use for acute and chronic low back pain patients.