The publication in JAMA Network Open, titled, "Transcutaneous Electrical Nerve Stimulation and Pain With Movement in People With Fibromyalgia: A Cluster Randomized Clinical Trial."
The study evaluated the use of a modified Quell device, an FDA-authorized nonpharmacological wearable stimulation device, when added to outpatient physical therapy ("PT") for people with fibromyalgia. The trial enrolled 384 participants [that completed baseline data collection], including 191 individuals in the PT-Quell group and 193 individuals in the PT-only group.
At day 60, reduction in movement-evoked pain was significantly greater in the PT-Quell group compared with the PT-only group, (between-group difference, −1.2 points [95% CI, −1.6 to −0.7]; P<.001), and statistically significant improvements favoring the PT-Quell group were also observed across several other secondary measures, including resting pain, pain interference, movement-evoked fatigue, resting fatigue, and fibromyalgia impact (FIQR) during the randomized phase. The benefits of Quell were observed within 30 days and were sustained for up to six months. Among respondents, 81% reported finding Quell helpful, and 55% continued to use Quell daily.