WOBURN, Mass.—NeuroMetrix, Inc. announced today that Quell technology has been selected for use in a large, randomized, pragmatic clinical trial of transcutaneous electrical nerve stimulation (TENS) for fibromyalgia. The clinical trial is funded by the National Institutes of Health (NIH).
“We are honored that Drs. Sluka and Crofford and their colleagues have chosen to use Quell technology for this first-of-its-kind TENS clinical trial. Fibromyalgia is a common chronic pain condition that is difficult to manage and can benefit from new treatment options,” said Shai N. Gozani, M.D., Ph.D., president and chief executive officer of NeuroMetrix. “This novel pragmatic study will inform the clinical use of TENS for fibromyalgia. We also expect that our experience with this and other ongoing studies will guide development of a new fibromyalgia-focused Quell device.”
Fibromyalgia is characterized by widespread musculoskeletal pain accompanied by fatigue, sleep and mood disturbances. It affects an estimated 2 to 4 percent of the U.S. population, and is most often diagnosed between the ages of 30 and 50. The cause of fibromyalgia remains unclear, but scientific studies point to abnormalities in the way the brain processes normal sensations and pain. Although several drugs are approved for treating fibromyalgia pain, there is an unmet need for safe, non-pharmacological options.
In a recently published article, a sham-controlled, double-blind, randomized controlled trial of TENS using frequency and charge modulated pulses showed that TENS improved movement-evoked pain in patients with fibromyalgia.
The new trial is entitled “Fibromyalgia TENS in physical therapy study (FM-TIPS): An embedded pragmatic clinical trial,” a center-randomized, pragmatic trial of routine physical therapy with or without TENS. It is supported by NIH’s Helping to End Addiction Long-term (HEAL) Initiative, and by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The principle investigators are Drs. Kathleen Sluka of the University of Iowa and Leslie Crofford of Vanderbilt University.
The trial objectives include assessing the feasibility of using TENS in addition to physical therapy for treatment of patients with fibromyalgia, and determining if TENS use improves symptoms, increases adherence to physical therapy, increases the likelihood of meeting therapeutic goals and reduces medication use. A total of 660 patients will be enrolled.
NeuroMetrix’s Quell technology is a TENS platform with a proprietary neurostimulation microchip that provides flexible, precise, high-power nerve stimulation in small wearable devices. Quell supports Bluetooth low energy to communicate with mobile applications. The company is creating a custom Quell device and mobile application, in collaboration with the study investigators, for use in the FM-TIPS trial.
The use of Quell technology for fibromyalgia remains investigational only. The safety and effectiveness for this purpose has not been reviewed by the FDA.