The Nerivio (Theranica) TENS device has been found to provide similar pain relief as standard care medications as an alternative for patients with chronic migraines.
The Nerivio (Theranica) remote electrical neuromodulator has shown similar results to standard care medications in patients with chronic migraines, according to data from a post-hoc study analysis. Patients with chronic migraines, according to the study authors.1,2
“Chronic migraine is a particularly disabling condition, diagnosed when a migraine patient experiences migraine-induced headaches for at least 15 days each month,” lead researcher Brian Grosberg, director of the Hartford Healthcare Headache Program, said in a news release.1 “The recent consensus statement of the American Headache Society recommends that, in order to avoid medication overuse, patients with migraines who need to use acute treatments regularly should be instructed to limit medication use to an average of two headache days per week.”
The US Food and Drug Administration approved Nerivio in October 2020 as the first wearable device controlled by a smartphone to treat acute migraine headaches. Nerivio has since been approved for the acute treatment of episodic and chronic migraine headaches in adult and adolescent patients. At the onset of a migraine attack, the REN device, which is worn on the upper arm, triggers an internal analgesic mechanism called conditional pain modulation.
Among the 78 patients with chronic migraine, 62.8% of those treated with REN experienced significant pain relief within 2 hours of starting treatment compared to 48.7% of patients who received standard care (s = .056). Furthermore, 64.1% of patients in the REN group achieved consistent pain relief versus 57.7% of patients on standard care medications (s = .369) set.
Pain relief was achieved in single therapy in 23.1% of patients with chronic migraine with Nerivio compared with 19.2% of patients in the standard drug group (s = .532). Furthermore, REN and standard care medications produced 14.1% consistency in pain relief across multiple treatments (s = 1.00).
In a two-arm study published in pain medicineCombining the Nerivio device with the optional in-app Guided Imagery, Education and Relaxation (GIER) from Nerivio increased the proportion of patients with consistent pain relief and improved acute migraine symptoms versus treatment with REN therapy alone.3,4
The researchers evaluated 85 patients with migraine who were at least 18 years old who treated their attacks with REN in parallel with the GIER intervention (REN + GIER) and compared them individually on age and gender with 85 patients who used REN alone. After 2 hours of treatment, the REN + GIER group showed a statistically significantly higher proportion of patients who had achieved stable analgesia (s = .008), consistent improvement in function (s = .014), the continuous return of the normal function (s = .005) from the REN group only.
“Chronic migraine patients often have 4, 5, or even 6 headache days a week,” Grosberg said in the statement. “To treat them effectively and safely, we must expand standard first-line care treatment options beyond prescribed medications,” Grosberg said in the statement. “This research provides a robust comparison between REN and prescription medications, particularly triptans, strengthening the conclusion that REN provides a much-needed alternative for acute migraine treatment of standard care — without compromising efficacy.”1
1. A new study suggests that REN is comparable to standard care medications prescribed for the acute treatment of chronic migraine. New release. Theranica. September 19, 2022. Accessed September 30, 2022. https://www.prnewswire.com/news-releases/new-study-suggests-ren-comparable-to-standard-care-presigned-medications-for-acute- treatment – Chronic Migraine – 301626947.html
2. Grosberg B, Rabany L, Vizel M, et al. Comparing the efficacy of remote electrical neuromodulation and standard care medications for acute treatment of chronic migraine: a post-hoc analysis. Pain management. 2022; 12 (7): 837-844. doi: 10.2217/pmt-2022-0053.
3. A peer-reviewed study demonstrated the positive effect of Nerivio’s Guided Imagery, Education, and Relaxation (GIER) on response to migraine treatment. New release. Theranica. February 16, 2022. Accessed February 18, 2022. https://www.prnewswire.com/news-releases/peer-reviewed-study-shows-positive-impact-of-nerivios-guided-imagery-education-and-relaxation-gier-feature-on-migraine-treatment- Response 301483460.html
4. Buse DC, Rabany L, Lin T, Ironi A, Connelly MA, Bickel JL. Combining a directed intervention for education and relaxation (GIER) with remote electrical neuromodulation (REN) in the acute treatment of migraine. Payne Med. Published online February 11, 2022. doi: 10.1093/pm/pnac021