NeuroMetrix to sponsor study assessing impact of Quell on chronic low back pain
NeuroMetrix announced a clinical study of Quell Wearable Pain Relief Technology in patients with chronic low back pain at the Brigham and Women's Hospital Pain Management Center. This study is a 3-month single site, controlled, randomized clinical trial. The study will enroll 60 adult patients with a primary complaint of chronic low back pain. The subjects will be randomized to treatment with the Quell device or "treatment-as-usual." Subjects in both arms will use a smartphone app developed by the Pain Management Center that helps patients document and manage their pain. Study outcome measures include validated measures of pain, coping, level of disability, mood, healthcare utilization, and overall satisfaction. All subjects will be given Quantitative Sensory Testing at baseline. The study will also examine the potential benefits of Quell as a digital health intervention. The device integrates with a smartphone app that includes objective feedback to the subject about their therapy utilization and sleep.