WALTHAM, Mass.--(BUSINESS WIRE)--NeuroMetrix, Inc. (NURO), an innovative health-care company that develops wearable medical technology and point-of-care tests that help patients and physicians better manage chronic pain, nerve diseases, and sleep disorders, today announced preliminary results from a clinical study of the Quell Wearable Pain Relief device in subjects with chronic pain.
The study was an open-label, single-arm, flexible dosing, 60-day trial of Quell for treatment of chronic pain. The average age of the subjects was 56 years and 45% were female. Most had chronic pain for 1-10 years, although nearly a quarter had more than 15 years of pain. The subjects had 3 sites of pain on average and complex medical histories with arthritis (61%), diabetes (40%), sciatica (27%), and fibromyalgia (26%) as the most common. At baseline, 40% of the subjects had severe pain, with the remaining 60% reporting moderate pain.
The primary outcome measure was strongly positive with 81% (95% CI, 71 – 88%) of subjects rating Quell therapy as improving their chronic pain and overall health on a Patient Global Impression of Change scale. Secondary outcome measures were also positive with 67% of subjects reporting a reduction in use of pain medications. Pain intensity, relief, and interference, which were assessed using the Brief Pain Inventory, showed statistically significant improvement over the 60-day study period. The largest measured changes were in pain relief and interference with sleep, general activity, and walking ability.
"We are pleased with these results. They represent the first formal evaluation of self-administered wearable intensive nerve stimulation (WINS). Quell provided substantial pain relief and improvement in quality of life measures. The primary outcome measure was impressive with 81% of subject’s rating Quell therapy as improving their chronic pain and overall health. We were not surprised that two-thirds of the subjects reduced their use of pain medications, as we have consistently received this anecdotal feedback from Quell users over the past several months," said Shai N. Gozani, M.D., Ph.D. President and CEO of NeuroMetrix, Inc. “We look forward to completing data analyses and publishing the results.”
A study abstract, “Treatment of Chronic Pain with a Novel Wearable Transcutaneous Electrical Nerve Stimulator", was accepted for poster presentation at the PAINWeek 2015 Scientific Sessions, September 8-12 in Las Vegas. A Company representative will present the study results at the Poster Reception on September 10.
Study Design
This study was an open-label, single-arm, flexible dosing, 60-day trial of Quell for treatment of chronic pain. The study was designed to mimic real world use of Quell. Study subjects were asked to self-administer Quell daily to manage pain and were not given special instruction on the device, were not contacted during the 60-day study period, and were not asked to alter their analgesic medications or pain treatments. The primary outcome measure was the subject’s self-rated change in their chronic pain and overall health using a 5-point patient global impression of change (PGIC) scale. This measure represents the subject’s overall assessment of the efficacy of pain treatment including pain relief, quality of life, and side effects. Secondary outcome measures were change in use of pain medications and selected pain intensity, pain relief, and pain interference domains from the Brief Pain Inventory. Baseline subject characteristics and 30 and 60 day follow-up data were obtained via an online questionnaire. A total of 88 enrolled subjects completed the 60-day follow-up.
About Quell Wearable Pain Relief Device
Quell is an easy-to-use, over-the-counter device for relief of chronic pain. This first-of-its-kind wearable device utilizes NeuroMetrix’s patented, wearable intensive nerve stimulation (WINS) technology to provide drug-free pain relief. It is designed for people with nerve pain, sciatica, osteoarthritis and fibromyalgia, among other conditions. Quell is currently available through select healthcare professionals and online at www.QuellRelief.com.
About NeuroMetrix
NeuroMetrix is an innovative health-care company that develops wearable medical technology and point-of-care tests that help patients and physicians better manage chronic pain, nerve diseases, and sleep disorders. The company is located in Waltham, Massachusetts and was founded as a spinoff from the Harvard-MIT Division of Health Sciences and Technology in 1996. For more information, please visit www.NeuroMetrix.com.
