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Key study findings included:
- Quell was used an average of 35 hours per week by the study subjects.
- Study subjects reported statistically and clinically significant improvement in all pain outcomes.
- All pain outcomes exhibited a strong dose-response relationship.
- About 60% of subjects with high device utilization reported a large (at least 2 point) improvement in pain interference with activity or mood.
The design was a retrospective, observational cohort study that examined changes in chronic pain outcomes following 60 days of Quell use. The study data were obtained from Quell users who consented to upload their device usage and clinical data to the Quell Health Cloud and who rated their pain at baseline (before starting Quell therapy) and 60 days later. The primary outcome measures were changes in pain intensity and pain interference with sleep, activity, and mood on an 11-point numerical rating scale. Dose–response associations were evaluated by stratifying subjects into low (≤30 days), intermediate (31–56 days), and high (≥57 days) utilization.
The study population consisted of 713 subjects. The average age was 55 years and 52% were female. Most subjects had chronic pain for over 3 years. The subjects had 5 sites of pain on average and complex medical histories with arthritis (62%), prior low back injury (41%), herniated disc (30%), spinal stenosis (29%) and fibromyalgia (26%) as the most common. At baseline, 47% of the subjects had severe pain.
"We are pleased that the results of this large, real-world study of Quell effectiveness has been published. The findings confirm that Quell provides valuable incremental pain relief to many individuals with chronic pain," said
About Quell
Quell is an advanced, wearable technology for treating chronic pain. It can be worn during the day while active and at night while sleeping. Quell is drug-free and has been cleared by the
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Source:
Source: NeuroMetrix, Inc.