NeuroMetrix reports publication of randomized controlled trial of Quell
NeuroMetrix reported publication of results from a randomized controlled trial of Quell in subjects with chronic low back pain in the journal Pain Practice. The paper is titled "Outcome of a High Frequency Transcutaneous Electrical Nerve Stimulator Device for Low Back Pain: A Randomized Controlled Trial." The study was a three-month single site, controlled, randomized clinical trial. A total of 68 adult patients with a primary complaint of chronic low back pain were enrolled and randomized with equal probability to treatment with the Quell device or "treatment-as usual". Study subjects averaged 46.2 +/- 12.7 years of age and 60% were female. All subjects reported chronic low back pain as their primary complaint. Over half of the subjects reported multi-site pain. All subjects used a smartphone app developed by the Pain Management Center that helps patients document and manage their pain. Outcome measures included the Brief Pain Inventory, the Pain Catastrophizing Scale, the Pain Disability Index and the Hospital Anxiety and Depression Scale. All subjects were given Quantitative Sensory Testing at baseline. Several key findings from the trial include: Subjects in the experimental group reported significantly less pain compared to control subjects following 90 days of therapy. On average, subjects in the experimental group experienced a 1.2-point decrease in pain compared to no change in the control group. Subjects in the experimental group reported less overall pain-related interference in function compared to the control group. Subjects in the experimental group reported reduced pain catastrophizing scores compared to the control group. Subjects in the experimental group used their device 381 +/- 353 hours during the study.