Survey Results Highlight REN Efficacy for Menstrual Migraine

Remote electrical neuromodulation (REN) may provide a safe and effective nonpharmacological treatment option for patients suffering from menstrual migraine, according to study results published in Pain and Therapy.

Around 60% of women migraineurs suffer from attacks associated with menstruation, and menstrual migraines are often more painful, more disabling, of longer duration, and less responsive to treatment, authors wrote.

In addition, “pharmacotherapy in menstrual migraine is further complicated by the lack of strong evidence-based recommendation, the involvement of hormones, and in some cases the use of contraceptives,” they said.

Both the European and American headache associations recommend integration of neuromodulation into migraine care for certain patients, and previous research has indicated that REN is safe and clinically beneficial for treatment of adults with episodic or chronic migraine.

Specifically, the abortive treatment “stimulates mainly C and Aδ fibers in the upper arm to activate an endogenous analgesic mechanism termed conditioned pain modulation (CPM).”

To better understand the effectiveness, satisfaction, and safety of REN among women who use the treatment in their regular migraine care, investigators carried out an online survey among users.

All participants (n = 91) used Nerivio, a device from Theranica Bio-Electronics Ltd, and were recruited via an in-app notification and/or email. Patients were between the ages of 18 and 55 years, resided in the United States, and completed at least 4 treatment sessions between October 2019 and October 2020.

Menstrual migraine was defined as an affirmative reply to the prompt, “Do you usually experience migraines that occur 2 days before you get your period or during the first 3 days of your period (menstrual migraines)?” All participants were also prescribed a migraine therapy by a neurologist.

The majority of women were White (92%) and they had a mean age of around 35 years and an average number of 13 headache days per month. Of migraineurs included, “88 (96.7%) women had menstrually related migraine (attacks occur especially but not only during the perimenstrual period), and 3 women (3.3%) had pure menstrual migraine (attacks occur only with menstruation),” researchers wrote—a ratio that is consistent with the relative ratio of women with pure menstrual migraine in epidemiological studies.

Analyses revealed:

• 74.7% (68/91) reported that the treatment was at least moderately effective (moderately effective, 37.4%; very effective, 26.4%; extremely effective, 11%).
• 45.1% (41/91) reported satisfaction from REN (slightly satisfied, 33%; extremely satisfied, 12.1%), whereas 34.1% were neutral and 20.9% (19/91) were not satisfied.
• 100% of the participants reported that the treatment is at least moderately tolerable (moderately tolerable, 8.8%; very tolerable, 20.9%; extremely tolerable, 70.3%).
• 13.2% (12/91) of respondents reported mild short-term adverse effects.
• The treatment was reported not effective for cramps by 61.3% (46/75) of the participants (slightly effective, 29.3%; not effective, 32.2%).
• The treatment was reported not effective for pelvic pain by 63.2% (24/38) of the participants (slightly effective, 28.9%; not effective, 34.2%).

Adverse effects reported included a sore arm several days following treatment, bruised arm, nausea, dizziness, drowsiness, muscle twitching, arm numbness during treatment, and tingling in the arm and hand.

“This study provides hope for the many women whose migraine headaches are associated with menstruation,” said Hida Nierenburg, MD, the study’s lead author, in a statement. “This can be an especially important option for women who are taking other medications and may be at risk for drug-drug interactions.”

The retrospective self-reported nature of the study marks a limitation, as it may introduce recall bias. Findings may also not be generalizable to non-REN users, and clinical trials are warranted to better understand the treatment’s effects.

Reference

Nierenburg H, Rabany L, Lin T, et al. Remote electrical neuromodulation (REN) for the acute treatment of menstrual migraine: a retrospective survey study of effectiveness and tolerability. Pain Ther. Published online June 17, 2021. doi:10.1007/s40122-021-00276-7