Healthcare company and wearable medical device developer, NeuroMetrix, Inc., has just announced it arrived at positive preliminary clinical trial results with Quell Wearable Pain Relief, an easy-to-use, over-the-counter device for chronic pain. This device is the first to feature the company’s patented, wearable intensive nerve stimulation (WINS) technology to induce drug-free pain relief.
The study was designed as an open-label, single-arm, flexible dosing, 60-day trial of Quell for treatment of chronic pain. Patients (n=88) enrolled in the study had a median age of 56 years old, and 45% were female. Most of them had been living with chronic pain for 1-10 years, while almost 25% have had chronic pain longer than 15 years. The participants reported pain in an average of 3 sites, and were also suffering from: arthritis (61%), diabetes (40%), sciatica (27%), and fibromyalgia (26%). Baseline data revealed 40% of patients suffered from severe chronic pain, while the remaining majority reported moderate pain.
The study’s primary outcome was achieved with 81% of participants testifying Quell therapy improved their chronic pain and overall health, according to the Patient Global Impression of Change scale. Secondary outcome measures were also favorable, with 67% of patients reporting a reduced dependency on their pain medications. The Brief Pain Inventory was used to assess pain intensity, relief, and interference, which participants said were reduced over the 60-day study period. The largest measured changes were related with 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.”
The 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.
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