External trigeminal neurostimulation in patients with chronic migraine

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Abstract

Aim: To assess the safety and efficacy of external trigeminal neurostimulation (e-TNS) as an add-on treatment in chronic migraine (CM) prophylaxis. Materials & methods: A prospective observational open-label study was conducted on CM patients observed at baseline and 3 months after starting daily sessions of 20 min with e-TNS (Cefaly ^®). Results: A total of 24 volunteers affected by CM according to the ICHD-3 were included. At the 3 month follow-up, a >30% reduction of headache days was observed in four (16.5%) of 24 patients; a marginal headache improvement was observed in ten (42%) patients, with no or minor adverse effects (four of 24 patients). Conclusion: e-TNS may constitute a safe preventive treatment in CM, its limited efficacy is not statistically significant.

Abstract

Plain language summary

Migraine is one of the most prevalent and disabling diseases in the world. In chronic migraine cases, patients have headache ≥15 days/month, of which at least eight are migraines, for >3 months and often develop a medication overuse headache because of the excessive intake of drugs. Preventive therapies include, among others, peripheral nerve stimulation. In our study, 24 patients affected by chronic migraine were asked to use a peripheral nerve stimulation device (Cefaly ^®) for 20 min daily for 3 months. During this period, we evaluated the efficacy and safety of the treatment using specific headache diaries in which patients collect information about their symptoms and disability. Our results show a limited and not statistically significant reduction in headache days in a group of patients (‘responders’) without serious adverse reactions.

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An observational open-label study to assess external trigeminal neurostimulation as add-on treatment in chronic migraine concludes that external trigeminal neurostimulation may constitute a safe but not efficacious preventive treatment in chronic migraine patients.

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Most cited references 31

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Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition

(2018)

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Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.

Robert H Dworkin, Dennis C Turk, Kathleen Wyrwich … (2008)

A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments.

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Migraine prevalence, disease burden, and the need for preventive therapy.

R Lipton, M. Bigal, M. Diamond … (2007)

1) To reassess the prevalence of migraine in the United States; 2) to assess patterns of migraine treatment in the population; and 3) to contrast current patterns of preventive treatment use with recommendations for use from an expert headache panel. A validated self-administered headache questionnaire was mailed to 120,000 US households, representative of the US population. Migraineurs were identified according to the criteria of the second edition of the International Classification of Headache Disorders. Guidelines for preventive medication use were developed by a panel of headache experts. Criteria for consider or offer prevention were based on headache frequency and impairment. We assessed 162,576 individuals aged 12 years or older. The 1-year period prevalence for migraine was 11.7% (17.1% in women and 5.6% in men). Prevalence peaked in middle life and was lower in adolescents and those older than age 60 years. Of all migraineurs, 31.3% had an attack frequency of three or more per month, and 53.7% reported severe impairment or the need for bed rest. In total, 25.7% met criteria for "offer prevention," and in an additional 13.1%, prevention should be considered. Just 13.0% reported current use of daily preventive migraine medication. Compared with previous studies, the epidemiologic profile of migraine has remained stable in the United States during the past 15 years. More than one in four migraineurs are candidates for preventive therapy, and a substantial proportion of those who might benefit from prevention do not receive it.

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Author and article information

Contributors

Michele Trimboli: (View ORCID Profile)

Journal

Title: Pain Management

Abbreviated Title: Pain Management

Publisher: Future Medicine Ltd

ISSN (Print): 1758-1869

ISSN (Electronic): 1758-1877

Publication date Created: March 2023

Publication date (Print): March 2023

Volume: 13

Issue: 3

Pages: 185-192

Affiliations

[1 ]Department of Neurology, AOR San Carlo, Potenza, Italy

[2 ]Department of Medical & Surgical Sciences, Institute of Neurology, Magna Græcia University, Catanzaro, Italy

[3 ]Department of Medical & Surgical Sciences, Anesthesia & Intensive Care, Magna Graecia University, Catanzaro, Italy

[4 ]Department of Business Administration & Law, University of Calabria, Cosenza, Italy

Article

DOI: 10.2217/pmt-2022-0082

SO-VID: b077bd67-a8d6-4660-ada3-7039034ae277

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External trigeminal neurostimulation in patients with chronic migraine

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Special issue: The European Union’s External Action: Views from the Outside

Most cited references 31

Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition

Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.

Migraine prevalence, disease burden, and the need for preventive therapy.

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