Abstract
Background: A recent randomized controlled study showed that 66.7% (66/99) and 37.4% (37/99) of people undergoing remote electrical neuromodulation (REN), a novel non-pharmacological migraine treatment, achieve pain relief and pain freedom, respectively, at 2 h post-treatment. The participants who completed the 6-weeks double-blind phase of this study were offered to participate in an open-label extension (OLE) with an active REN device.Objective: This study investigated the clinical use of REN, focusing on its potential in reducing the use of acute migraine medications.Methods: The parent study for this open-label extension (OLE) was a randomized, double-blind, sham-controlled study of acute treatment conducted on 296 participants enrolled at 12 sites in the USA and Israel. This study included a run-in phase, in which migraine attacks were treated with usual care, and an 8-weeks double-blind treatment phase. One hundred sixty participants continued in an 8-weeks OLE phase in which they could incorporate a REN device into their usual care. Medication use rate (percentage of participants who treated their attacks only with REN and avoided medications in all their attacks) and pain outcomes at 2 h post-treatment were compared between the OLE and the run-in phase in a within-subject design.Results: The analyses were performed on 117 participants with episodic migraine. During the OLE, 89.7% of the participants treated their attacks only with REN and avoided medications in all their attacks compared with 15.4% in the run-in phase (p < 0.0001). The rates of pain relief and pain-free in at least 50% of the treatments at 2 h post-treatment were comparable (pain relief: 58.1% in the run-in phase and 57.3% in the OLE, p = 0.999; pain-free: 23.1% in the run-in vs. 30.8% in the OLE, p = 0.175).Conclusions: REN may reduce the use of acute migraine medications. Thus, incorporating REN into usual care may reduce the risk for medication overuse headache (MOH). Future studies should evaluate whether REN reduces the use of acute migraine medications in a population at risk for MOH.
Highlights
Medication overuse headache (MOH) may occur in patients with a pre-existing disorder such as migraine as a consequence of frequent acute medication use with treatments such as triptans, ergots, barbiturates, or opiates as a complication of their underlying condition [1, 2]
Of the 296 participants enrolled in the parent study, 252 were randomized to active and sham groups; 245 participants were eligible to continue in the open-label extension (OLE) [seven participants withdrew from the study [15]], of which 160 participants continued in the OLE
There was no reduction in pain relief and pain-free rates associated with the incorporation of remote electrical neuromodulation (REN) into usual care, with over 57% of the participants achieving pain relief at 2 h post-treatment in at least 50% of their treatments and over 30% of the participants achieving a pain-free outcome at 2 h post-treatment in at least 50% of their treatments
Summary
Medication overuse headache (MOH) may occur in patients with a pre-existing disorder such as migraine as a consequence of frequent acute medication use with treatments such as triptans, ergots, barbiturates, or opiates as a complication of their underlying condition [1, 2]. High-frequency usage of acute medications such as triptans, ergots, barbiturates, anti-inflammatories, or opiates may cause adverse events (AEs) including gastrointestinal issues, renal or hepatic toxicities, dependency, and withdrawal, and interference with other medications and medical conditions. There are several non-pharmacological interventions used for the treatment of headache, including behavioral techniques (e.g., biofeedback, cognitive behavioral therapy, and relaxation) and neuromodulation methods (e.g., external trigeminal nerve stimulation, non-invasive vagus nerve stimulation, and singlepulse transcranial magnetic stimulation). The participants who completed the 6-weeks double-blind phase of this study were offered to participate in an open-label extension (OLE) with an active REN device
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