Clinical trials and other research results play an increasingly important role in wearable health tech devices. A new study evaluated transcutaneous electrical nerve stimulation (TENS) as an in-home treatment. We’ve written previously about TENS devices used to mitigate pain. We covered the NeuroMetrix Quell neurostim wearable several times, starting in 2015 when we reported the FDA cleared the Quell wearable as a medication-free way to manage pain.
NeuroMetrix recently announced a peer-reviewed publication of a study that analyzed the at-home treatment effect of Quell neurostimulation with 119 patients with fibromyalgia. Published in the Journal of Pain Research, the study compared 3-months of treatment with the Quell device in a double-blind, randomized, sham-controlled trial. The sham device was an extremely low power dose Quell unit. Neither the patients nor the testers knew who was using the real, full-strength Quell devices or the de-powered wearables. The subject patients were classified with several measures of lower or higher pain sensitivity.
The overall outcome of the study revealed that fibromyalgia patients using the real Quell unit had “modest treatment effects of reduced disease impact, pain, and functional impairment” from wearable TENS. However, the treatment effects were greater among the patients with higher rather than lower pain sensitivity. In the justifiably understated language of responsible clinical study reports, the authors concluded, “Wearable TENS may be a safe treatment option for people with fibromyalgia.” We can fill in the rest ourselves: “… especially for people with high pain sensitivity.”
We will continue to watch for more clinical studies that explore the effectiveness of wearables and other digital health solutions.
