Remote electrical neuromodulation for reducing procedural pain in patients with chronic migraine receiving onabotulinumtoxinA injections: A randomized sham-controlled study
Abstract
Background: OnabotulinumtoxinA (BoNT-A) is an established preventive treatment for chronic migraine but involves 31 to 40 injections per session, often causing discomfort and post-procedural headaches. Remote electrical neuromodulation (REN) is a noninvasive therapy with efficacy in migraine treatment via conditioned pain modulation but has not been evaluated for procedural pain. This study evaluated REN's effectiveness in reducing acute procedural pain and postprocedural headache associated with BoNT-A injections.
Methods: This was an investigator-initiated single-center, randomized, single-blind, sham-controlled crossover study enrolled 80 adults (aged 22 to 74 years) with chronic migraine undergoing routine BoNT-A treatment. Each participant received one injection session without a device, followed by sessions using active REN and sham in randomized order. REN was applied to the upper arm 10 min prior to injections and removed after injection completion. Pain intensity was measured using a visual analog scale (0 to 100) at pre-procedure, intra-procedure, and post-procedure time points. The primary outcome was procedural pain intensity, and secondary outcomes included post-procedural headache incidence and adverse events. Due to clear benefit, the study was terminated early based on predefined stopping criteria.
Results: Final analysis of 60 participants (mean age 48.0 years; 49/60, 82% female) demonstrated that pre-procedural pain levels were not significantly different…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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