In particular, researchers found that Quell lessens pain interference with activity and mood, and concluded that the device is a practical approach to help reduce chronic pain throughout the body.
“We are pleased that the results of this large, real-world study of Quell effectiveness has been published. The findings confirm that Quell provides valuable incremental pain relief to many individuals with chronic pain,” Shai N. Gozani, MD, PhD, president and CEO of NeuroMetrix, said in a press release.
Quell, which is worn on the upper calf, delivers electrical stimulation to sensory nerve cells, providing widespread pain relief. It can be used both during the day and at night during sleep. An app allows users to personalize the therapy, including intensity and number of sessions, and to keep track of their pain and other health measures such as sleep and activity.
This technology has been cleared by the U.S. Food and Drug Administration for the treatment of chronic pain without a prescription.
In this observational study, researchers evaluated if Quell could provide significant relief to patients living with chronic pain.
The study included 713 Quell users who agreed to have their usage and data tracked for 60 days. All patients rated their pain intensity and pain interference with mood, activity, and sleep both before starting the therapy and after 60 days of use. Data was uploaded by the patients into the Quell Health Cloud, a database of clinical data from Quell users run by NeuroMetrix.
Most participants experienced moderate-to-severe pain every day, persisting for more than three years. Pain was felt at several points of the body, nearly five sites on average per patient. Almost all participants (97.2%) had lower back or lower extremity pain. A lot of them (72.9%) also reported pain in the upper body (upper extremity, trunk, neck, head, or facial pain).
Several pain-causing health conditions affected the patients. Only 125 (17.5%) experienced a single condition, while 461 (64.7%) were affected by three or more. At least 25% of patients reported having fibromyalgia.
At the end of the 60-day period, participants reported a significant improvement in all pain measures.
Researchers observed the most significant changes in pain interference with activity and mood. Quell reduced the impact of pain on daily activities and mood in 48.7% of patients.
Improvements were dependent on the degree of Quell use. Participants used the device for an average of 35 hours per week, and results showed that the more it was used, the more likely a patient was to experience pain relief.
The percentage of patients with a 30% or more decrease in pain intensity increased from 18% of participants who used Quell less frequently — about twice a week — to 33% of participants who wore it daily. A decrease in the influence of pain on activity and mood followed the same trend.
This study was the first to be published using data retrieved from the Quell Health Cloud. The database has collected more than 2.5 million hours of patient data including usage, therapy, sleep, activity and gait, and is one of the world’s largest chronic pain databases, according to NeuroMetrix.
“We believe that our ability to leverage the Quell Health Cloud to conduct sophisticated, large scale scientific and clinical research is a substantial long term competitive advantage,” Gozani said.