NeuroMetrix, Inc. 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.
According to the Centers for Disease Control and Prevention (CDC), low back pain is the second most common cause of disability in U.S. adults. The incidence of low back pain is as high as 12 percent of the general population at any given point in time, and nearly 25 percent of U.S. adults report having had it at some point over any one-month period. The condition is costly with total costs estimated to be up to $200 billion annually.
Low back pain persisting for 3 months or longer is defined as chronic. There are few accepted treatments for chronic low back pain that do not involve prescription medication, manipulation, invasive procedures, or surgery.
Quell utilizes neurostimulation technology to provide relief from chronic pain. The wearable device is lightweight and can be worn during the day while active, and at night while sleeping. In addition to analgesic therapy, Quell objectively tracks utilization and various health metrics including sleep and activity. In a recently published study of Quell in chronic pain that included subjects with low back pain, 81 percent of participants reported improvement in their chronic pain on the Patient Global Impression of Change (PGIC) scale. In addition, 67 percent of participants reported a reduction in use of analgesics.
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 (Brief Pain Inventory), coping (Pain Catastrophizing Scale), level of disability (Pain Disability Index), mood (Hospital Anxiety and Depression Scale), 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.
“We are honored to partner with the Brigham and Women’s Hospital Pain Management Center on this important study. Chronic low back pain is a major health problem and represents a natural application for Quell therapy,” said Shai N. Gozani, M.D., Ph.D., president and CEO of NeuroMetrix. “This study will analyze the potential for Quell to reduce pain and improve quality of life in people suffering from chronic low back pain. We look forward to learning a great deal from this study.”
About Brigham and Women’s Hospital Pain Management Center
Boston’s Brigham and Women’s Hospital (BWH) is an international leader in virtually every area of medicine and has been the site of pioneering breakthroughs that have improved lives around the world. A major teaching hospital of Harvard Medical School, BWH has a legacy of excellence that continues to grow year after year. The Brigham and Women’s Hospital Center for Pain Therapy and Research encompasses two programs: Clinical care and education is provided through the Pain Management Center, and basic science and clinical research is conducted through the Pain Research Center. The BWH Pain Management Center is a nationally recognized model for innovation and excellence.
NeuroMetrix is a commercial stage, innovation driven healthcare company combining bioelectrical and digital medicine to address chronic health conditions including chronic pain, sleep disorders, and diabetes. The company’s lead product is Quell, an over-the-counter wearable therapeutic device for chronic pain. Quell is integrated into a digital health platform that helps patients optimize their therapy and decrease the impact of chronic pain on their quality of life. The company also markets DPNCheck, a rapid point-of-care test for diabetic neuropathy, which is the most common long-term complication of Type 2 diabetes. The company maintains an active research effort and has several pipeline programs, including a therapeutic device for restless leg syndrome. The company is located in Waltham, MA and was founded as a spinoff from the Harvard-MIT Division of Health Sciences and Technology in 1996. For more information: www.NeuroMetrix.com.
(Source: Business Wire)