Quell Plus Physical Therapy Reduces Fibromyalgia Pain by 1.2 Points in 384-Patient Trial
electroCore published a 384-patient cluster randomized trial evaluating Quell plus outpatient physical therapy in fibromyalgia, enrolling 191 in PT-Quell and 193 in PT-only groups. At day 60, PT-Quell reduced movement-evoked pain by 1.2 points versus PT alone, sustained six months, with 81% reporting daily use.
1. Trial Design and Enrollment
electroCore enrolled 384 participants into a cluster randomized clinical trial comparing outpatient physical therapy combined with the modified Quell device (191 participants) to physical therapy alone (193 participants) for fibromyalgia pain management.
2. Efficacy Outcomes
At day 60, the PT-Quell group experienced a 1.2-point greater reduction in movement-evoked pain compared to PT-only, with statistically significant improvements in resting pain, fatigue, pain interference and fibromyalgia impact; benefits appeared within 30 days and were sustained up to six months.
3. Patient Adoption and Market Potential
Among respondents, 81% found the Quell device helpful and 55% continued daily use; with fibromyalgia affecting an estimated 2–4% of the population, Quell represents the first FDA-cleared non-drug treatment option, highlighting a substantial commercial opportunity for electroCore.