Key study findings included:
- Quell was used an average of 36 hours per week by the study participants for 60 days.
- Study participants reported statistically and clinically significant decreases in pain interference with activity and mood. Daily users also reported a clinically significant decrease in pain intensity and less pain interference with sleep.
- All pain outcomes exhibited a dose-response relationship, suggesting that frequent Quell use was associated with less pain and improved quality of life.
- There were no differences in pain outcomes or dose-response associations between study participants with distal chronic pain (i.e., affecting the feet and legs) and proximal chronic pain (i.e., hips, lower back and upper body). This result suggests that Quell produces pain relief beyond the site of stimulation at the calf.
The design was a retrospective, observational cohort study that compared pain outcomes in participants with distal and proximal chronic pain following 60 days of Quell use. The study data were obtained from 1676 Quell users who opted to upload their device usage and clinical data to the Quell Health Cloud™ and who rated their pain at baseline (before starting Quell therapy) and 60 days later. The primary outcome measures were changes in pain intensity and pain interference with sleep, activity, and mood on an 11-point numerical rating scale.
“This study is the largest to demonstrate that fixed-site, high-frequency transcutaneous electrical nerve stimulation may have widespread effects beyond the site of stimulation, which is at the upper calf for Quell," said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix, Inc. "This is an important study for further establishing the Quell mechanism of action and is representative of our efforts to leverage the Quell Health Cloud to conduct sophisticated, large scale scientific and clinical research.”
Additional clinical and scientific research on Quell wearable pain relief can be found at QuellRelief.com/.
Quell is an advanced, wearable technology for treating chronic pain. It can be worn during the day while active and at night while sleeping. Quell is drug-free and has been cleared by the FDA for treatment of chronic pain without a prescription. Quell has been shown in multiple clinical studies to relieve chronic pain and, in a published study, 4 out of 5 users reported improvement in chronic pain. Quell users can personalize and manage therapy discreetly via the Quell app. Quell also offers health tracking relevant to chronic pain sufferers including pain, sleep, activity, and gait. Quell users can synchronize their data with the Quell Health Cloud, which provides customized feedback and powers one of the world’s largest chronic pain databases. Quell is available online and through select retailers. Visit QuellRelief.com for more information.
NeuroMetrix is an innovation driven healthcare company combining neurostimulation 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. 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. For more information, please visit NeuroMetrix.com.
SVP and Chief Financial Officer
Source: NeuroMetrix, Inc.