Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain.

Project Summary The goal of this project is to develop a multimodal neuromodulatory opioid sparing device for low back paindemonstrate effective pain reliefthen evaluate opioid reduction for patients with acute or chronic back pain presenting for treatmentPain and opioid use disorderOUDare intricately relateddependence begins for up towith medications prescribed for paineither directly or through pills left in circulationCurrentlythere is no proven approach to help reduce long term opioid use for patients with chronic non cancer painWhat is known is that prescriptions of opioids for acute low back pain are a factor in eventual OUDand unused opioids in circulation are increasingly abused for non medical reasonsFor the already dependent with chronic painone barrier to reduction is fear of ongoing or increasing painAn effective non pharmaceutical pain reliever could reduce home opioid prescriptions for acute painand aid chronic pain patients seeking to weanAcute and chronic low back pain are among the most common sources of short and long term disabilityOpioids are commonly prescribedbut no better than nonaddictive solutions for chronic low back painNeuromodulationcoldhigh frequency vibrationlow frequency whole body vibrationacupressureheatand support are effective for manybut no current device combines these multiple modalities of pain reliefOne recent study found a surgically placed neuromodulatory device significantly decreased opioid use for patients with chronic low back painLow 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 usePatients with chronic pain report benefitting from multiple pain relief strategies over timeBecause having options improves the perception of controlthe ideal pain relief device would incorporate multiple pain relieving modalities to reduce catastrophizingTo relieve sharp painwe created an NICHD fundedBuzzyneuromodulatory device combining high frequency vibration and icenow proven effective in overindependent clinical trialsTo address low back painourDuoThermdevice incorporates the Buzzy frequencycoldheatacupressureand two additional frequenciesPreliminary data fromsubjects demonstrated substantial and sustained pain reductiondistinct preferences for vibration frequenciesand strong commercial desire for the productThis project will develop and clinically evaluate DuoTherman innovative opioid sparing therapeuticThis patient controlled external neuromodulation device will be designed to address acute and chronic LBPAfter validating effective pain relief with DuoTherm compared to placebowe 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 painwith multiple patient controlled effective neuromodulatory pain relief options including vibrationpressurecold and heatFear of pain and disabilityorcatastrophizingincreases opioid usebut is reduced when patients have effective options and feel control over painAfter proving that providing a multimodal device is effective for painthe project will determine whether the availability of an effective home therapy device reduces opioid use for acute and chronic low back pain patients