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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 between baseline and the active REN or sham (p > 0.999 and p = 0.485, respectively). However, during and after BoNT-A administration, the active REN group reported significantly lower pain scores compared to both the sham and baseline conditions. At intra-procedure, the REN group experienced a mean pain reduction of 15.0 points (p 0.999 for both intra-procedure and post-procedure). Additionally, REN lowered the incidence of headache as an adverse event, with only 15% (8/52) of participants experiencing post-procedural headache compared to 55% (29/53) in the sham group and 39% (23/59) at baseline (odds ratio = 0.28, 95% confidence interval: 0.10 to 0.69, p = 0.008). No additional adverse events were reported. CONCLUSIONS: REN significantly reduces procedural pain and post-procedural headache associated with BoNT-A injections for chronic migraine and may serve as a noninvasive, easily implemented pain management strategy for acute procedural pain. REN represents a promising approach to improving patient comfort during routine migraine treatment as well as reducing post-procedural headache.
Cheng et al. (Wed,) studied this question.