Efficacy of high-frequency transcutaneous electrical nerve stimulation for chronic low back pain: does hypersensitivity matter?

Preliminary Results from Quell Chronic Low Back Pain Study Presented at World Institute of Pain World Congress

Preliminary results from a study of Quell® wearable pain relief in chronic low back pain were presented at the 9th World Congress of the World Institute of Pain in Dublin, Ireland.

The study was conducted by Dr. Robert Jamison and his colleagues at the Brigham and Women’s Hospital Pain Management Center in Boston, MA.  The poster presentation was titled

“Efficacy of high-frequency transcutaneous electrical nerve stimulation for chronic low back pain: does hypersensitivity matter?”

and included the following key findings:

  • Subjects in the experimental (Quell) group demonstrated reduced pain intensity compared to control subjects.
  • Subjects in the experimental group exhibited reduced pain interference with function and pain compared to the control group.
  • Subjects in the experimental group with greater sensitivity on quantitative sensory testing had more disability and higher Quell use, but sensitivity did not predict pain outcomes.
  • Subjects in the experimental group used their device 381 ± 353 hours during the study.

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 or “treatment-as usual.”

Study subjects averaged 46.2 ± 2.7 years of age.

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.

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. For those with chronic low back pain (low back pain persisting for three or more months), there are few accepted treatments that do not involve prescription medication, manipulation, invasive procedures, or surgery.

“Chronic low back pain is a major health problem and represents a natural application for Quell,” said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix.

“The preliminary results from this study led by Dr. Robert Jamison are encouraging and we look forward to formal publication of the study findings.”

About Brigham and Women’s Hospital Pain Management Center

Boston’s Brigham and Women’s Hospital (BWH) is an international leader in virtually every area of medicine and has been the site of pioneering breakthroughs that have improved lives around the world. A major teaching hospital of Harvard Medical School, BWH has a legacy of excellence that continues to grow year after year. The Brigham and Women’s Hospital Center for Pain Therapy and Research encompasses two programs: clinical care and education is provided through the Pain Management Center, and basic science and clinical research is conducted through the Pain Research Center. The BWH Pain Management Center is a nationally recognized model for innovation and excellence.

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 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.

About NeuroMetrix

NeuroMetrix is an innovation driven healthcare company combining neurostimulation and digital medicine to address chronic health conditions including chronic pain, sleep disorders, and diabetes. The company’s lead product is Quell, an over-the-counter wearable therapeutic device for chronic pain. The company also markets DPNCheck®, a rapid point-of-care test for diabetic neuropathy, which is the most common long-term complication of Type 2 diabetes.

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