NeuroMetrix Reports Publication of Randomized Controlled Trial of Quell Wearable Pain Relief in Chronic Low Back Pain
January 22 2019 - 1:00PM
NeuroMetrix, Inc. (Nasdaq:NURO) today reported publication of
results from a randomized controlled trial of Quell® in subjects
with chronic low back pain in the journal Pain Practice. The
paper is titled “Outcome of a High Frequency Transcutaneous
Electrical Nerve Stimulator (hfTENS) Device for Low Back Pain: A
Randomized Controlled Trial.” The study was conducted by
Dr. Robert Jamison and colleagues at the Brigham and
Women's Hospital Pain Management Center in Boston, MA.
The study was a three-month single site, controlled, randomized
clinical trial. A total of 68 adult patients with a primary
complaint of chronic low back pain were enrolled and randomized
with equal probability to treatment with the Quell device
(experimental group) or "treatment-as usual" (control group).
Study subjects averaged 46.2 ± 12.7 years of age and 60% were
female. All subjects reported chronic low back pain as their
primary complaint. Over half of the subjects (57%) reported
multi-site pain. All subjects used a smartphone app developed
by the Pain Management Center that helps patients document and
manage their pain. Outcome measures included the Brief Pain
Inventory, the Pain Catastrophizing Scale, the Pain Disability
Index and the Hospital Anxiety and Depression Scale. All
subjects were given Quantitative Sensory Testing at baseline.
Several key findings from the trial include:
- Subjects in the experimental group reported significantly less
pain compared to control subjects following 90 days of
therapy. On average, subjects in the experimental group
experienced a 1.2-point decrease in pain (on a 0 to 10 scale)
compared to no change in the control group.
- Subjects in the experimental group reported less overall
pain-related interference in function (e.g., activity, sleep, mood,
work) compared to the control group.
- Subjects in the experimental group reported reduced pain
catastrophizing scores compared to the control group.
- Subjects in the experimental group used their device 381 ± 353
hours during the study.
According to the Centers for Disease Control and
Prevention (CDC), low back pain is the second most common
cause of disability in US adults. The incidence of low back pain is
as high as 12 percent of the general population at any given point
in time, and nearly 25 percent of US adults report having had it at
some point over any one-month period. The condition has a
significant economic impact, with total costs estimated to be up
to $200B annually.
"Chronic low back pain is a major health problem with unmet
therapeutic needs," said Shai N. Gozani, M.D., Ph.D.,
President and CEO of NeuroMetrix. "The results published in
this trial, along with other studies published in peer-reviewed
journals, suggest that Quell may be a useful treatment option for
individuals with chronic low back pain.”
About Quell
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.
About NeuroMetrix
NeuroMetrix is a commercial stage, innovation driven healthcare
company combining neurostimulation and digital medicine to address
chronic health conditions including chronic pain, sleep disorders,
and diabetes. The Company has two primary products. Quell is an
over-the-counter wearable therapeutic device for chronic pain.
DPNCheck® is 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 http://www.neurometrix.com.
Source: NeuroMetrix, Inc.
NeuroMetrix, Inc. Thomas T. Higgins, 781-314-2761 SVP and Chief
Financial Officer Neurometrix.ir@neurometrix.com
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