The article reports an intention-to-treat analysis of a double-blind, randomized, sham-controlled trial that compared 3-months of at-home treatment with a standard (active) or low dose (sham) Quell device in 119 subjects with fibromyalgia.
Note: The use of Quell for fibromyalgia is investigational and has not been cleared or approved by the
Fibromyalgia is a common form of chronic pain that is also accompanied by fatigue, sleep, cognitive and mood disturbances. It affects an estimated 2 to 6 percent of the
Quell is an advanced, non-invasive, nerve stimulation device that is covered by 18 U.S. utility patents. It is the only wearable neurostimulator that is enabled by a custom designed microchip that provides precise, high-power nerve stimulation in a form factor the size of a credit card. Quell utilizes position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night. The device supports Bluetooth® low energy (BLE) to communicate with the Quell app, which is available for iOS and Android mobile devices. Quell is currently indicated for symptomatic relief and management of chronic lower extremity (knee, foot and leg) pain. It is available over-the-counter for this use. Visit QuellRelief.com for more information.
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Source: NeuroMetrix, Inc.