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.”
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
SVP and Chief Financial Officer
Source: NeuroMetrix, Inc.