According to the Centers for Disease Control and Prevention (CDC), low back pain is the second most common cause of disability in US adults. The incidence of low back pain is as high as 12% of the general population at any given point in time, and nearly 25% of US 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 $200B 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% of participants reported improvement in their chronic pain on the Patient Global Impression of Change (PGIC) scale. In addition, 67% 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.”