NeuroMetrix Inc‘s Quell technology has been selected for use in a large, NIH-funded, randomized, pragmatic clinical trial of TENS and physical therapy for fibromyalgia.
The study, titled “Fibromyalgia TENS in physical therapy study (FM-TIPS): An embedded pragmatic clinical trial,” is a center-randomized, pragmatic trial of routine physical therapy with or without TENS. The objectives of the trial are to assess the feasibility of using TENS in addition to physical therapy for treatment of patients with fibromyalgia and to determine 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.
It is supported by NIH’s Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative. The principal investigators are Drs Kathleen Sluka of the University of Iowa and Leslie Crofford of Vanderbilt University.
Quell technology is an advanced TENS platform that is enabled by a proprietary neurostimulation microchip that provides flexible, precise, high-power nerve stimulation in small wearable devices. Quell supports Bluetooth low energy (BLE) to communicate with mobile applications. NeuroMetrix is creating a custom Quell device and mobile application in collaboration with the study investigators for use in the FM-TIPS trial, a media release from the company explains.
“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,” Shai N. Gozani, MD, PhD, President and CEO of NeuroMetrix, says in the release.
“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.”
[Source(s): NeuroMetrix Inc, Globe Newswire]