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81% of subjects reported improvement in chronic pain and overall health
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Two-thirds of subjects reported decreased use of pain medications
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Clinically significant improvement in pain relief, sleep, general
activity and walking ability
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.
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