Chronic Pain Clinical Trial
Official title:
Empower Opioid Misuse Theranova Study for Veterans With Chronic Pain
This study evaluates the effects of peripheral nerve stimulation on opioid craving and use and pain in participants with chronic non-cancer pain (NCP) and opioid misuse. Participants will be randomized to receive the active or sham control treatment for the duration of the study.
This pilot study aims to examine the feasibility, acceptability, and preliminarily examine efficacy of peripheral nerve stimulation with the Empower Neuromodulation System on reducing opioid craving and use and decreasing pain. Opioid prescribing for chronic pain has increased dramatically over the past several decades, with devastating public health consequences, including high rates of opioid misuse and overdose deaths. Safe nonpharmacological treatments are urgently needed. In this randomized, controlled study, thirty Veterans with chronic non-cancer pain (NCP) and opioid misuse will be recruited and randomly assigned (1:1) to either the Active or Control treatment. On Days 1-7, participants will undergo baseline monitoring, and on Days 8-21, participants will undergo daily nerve stimulation treatment. Pain scores, craving, and opioid use will be measured daily Days 0-21. Our goal is to provide an intervention that, alone or in conjunction with current treatments, reduces craving and reduces reliance on opioids in high-risk chronic pain patients. ;
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