The double-blind, randomized, sham-controlled trial was conducted at the
A poster titled "Outcome of TENS for Fibromyalgia: Randomized Sham-Controlled Trial" will be presented at the
- In the intention-to-treat (ITT) population, the treatment difference in the Patient Global Impression of Change (PGIC, primary endpoint) was not significant (sham 3.24 ± 0.26, active 3.58 ± 0.25, p=0.351). However, in a pre-specified subgroup analysis of subjects with elevated baseline pain sensitivity, the active treatment group exhibited a significant and clinically meaningful improvement compared to sham (sham 3.09±0.40, active 4.24 ± 0.37, p=0.032).
- Several secondary endpoints were positive in the ITT population. The reduction in the mean FIQR Total Score was significantly greater for active treatment (-14.0 ± 2.1) compared to sham (-6.6 ± 2.2), p=0.001. The Brief Pain Inventory (BPI) interference subscale and the painDETECT questionnaire (PDQ) also exhibited significant improvements compared to sham.
- There were few TENS related adverse events, and all were minor and self-limited.
An oral presentation titled "Baseline Pain Sensitivity Predicts Responder Rates of Wearable TENS Use in Fibromyalgia: Analysis of a Double-Blinded Randomized Sham-Controlled Trial" will be given at the 3rd
- In the ITT population, the FIQR responder rate (≥15% reduction) was 56% for the active device compared to 35% for sham (p=0.029).
- In subjects with elevated baseline pain sensitivity, the PGIC responder rate was 58% (active) versus 30% (sham), p=0.024. The pain responder rate (≥30% reduction) was 58% (active) versus 18% (sham), p=0.001.
"I would like to thank Dr.
Note: The use of Quell for fibromyalgia is investigational. The safety and effectiveness for this purpose has not been reviewed by the
Fibromyalgia is a disorder characterized by widespread chronic pain accompanied by fatigue, sleep, cognitive, balance and mood disturbances. It affects an estimated 2 to 6 percent of the US population, or as many as 5 to 15 million people, 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 FDA approved for managing fibromyalgia pain, there is an unmet need for safe and effective non-pharmacological treatments.
Quell is a novel transcutaneous electrical nerve stimulator (TENS) that is indicated for symptomatic relief and management of chronic lower extremity pain and is available over-the-counter. It is a wearable device that can be used during the day while active and at night while sleeping. Quell users can personalize and manage therapy discreetly via the Quell app. Quell also offers health tracking metrics relevant to chronic pain sufferers. Quell users can synchronize their data with the Quell Health Cloud®, which provides customized feedback and powers a large chronic pain outcomes database. Visit QuellRelief.com for more information.
SVP and Chief Financial Officer
Source: NeuroMetrix, Inc.