- mHealth wearables that focus on pain relief are finding validation as an alternative to opioids.
SPR Therapeutics, the Cleveland-based developer of a digital health platform for treatment of acute and chronic pain, has received $10 million in grants and contracts from the US Department of Defense for three projects.
In addition, Waltham, Mass.-based NeuroMetrix has announced the publication of a study in the Journal of Pain and Relief that indicates its Quell wearable is helping people reduce pain, with corresponding improvements in activity and mood.
An estimated 100 million Americans suffer from chronic pain, described as lasting more than three months. While the causes are many, from trauma and amputations to chronic diseases, the popular course or treatment until recently has been opioids. This, in turn, has created a pain management market worth, by some estimates, $635 billion a year.
The two companies are part of a growing digital therapeutics field, aimed at using mHealth and telehealth to replace medications – especially opioids - and improve clinical outcomes. And they’ve captured the attention of healthcare providers in both the US and the UK.
The DoD grants for SPR Therapeutics are part of an ongoing partnership between the company and the US government, which has received more than $30 million in grants and contracts for its SPRINT percutaneous Peripheral Nerve Stimulation therapy platform.
In this latest round, the DoD is giving the company $6 million to support a trial program comparing the mHealth platform against conventional medical treatment to reduce pain and opioid use in military service members. A $3 million grant, meanwhile, will go toward continuing research on the use of mHealth for pain management following surgery for combat and non-combat related orthopedic trauma.
In addition, the agency is awarding SPR Therapeutics a $1 million contract to adapt the company’s platform for independent use by other healthcare providers, including those outside the government ecosystem.
“The management of chronic and post-operative pain continues to be a challenge among US Military, veterans and the general public,” Maria Bennett, founder, President and CEO of SPR Therapeutics, said in a press release. “In the midst of the opioid crisis and the need for non-opioid pain treatment options, product refinements and data from additional studies of percutaneous PNS will support the independent, appropriate and effective use of our SPRINT PNS System for pain management.”
NeuroMetrix, meanwhile, is touting a study of more than 1,600 people with distal and proximal chronic pain who used the Quell wearable for at least 60 days. Those participating in the study transmitted their data – including changes in pain intensity and pain interference with sleep, activity, and mood on an 11-point numerical rating scale – to researchers for analysis at the beginning and end of the two-month project.
According to the study, participants used the device an average of 36 hours per week, and reported “statistically and clinically significant decreases in pain interference with activity and mood” and “a clinically significant decrease in pain intensity and less pain interference with sleep.”
“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,” Shai N. Gozani, MD, PhD, the company’s President and CEO, said in a press release. “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.”
Two years ago, NeuroMetrix launched a partnership with San Diego’s Scripps Translational Science Institute (now called the Scripps Research Translational Institute) to analyze how Quell might be used to help people living with cancer.
“This primary end point was chosen to provide a novel way for patients with cancer to have optimal pain control while reducing their overall opioid use,” SRTI officials said. “The study will also examine the potential benefits of Quell as a digital health intervention. The device integrates with a smartphone app that includes electronic pain tracking and provides objective feedback to the subject about their therapy utilization and sleep.”