Highlights
- •Transcutaneous occipital nerve stimulation (tONS) was well tolerated and effective.
- •tONS at 100 Hz reduced headache days and headache duration more effectively.
- •tONS was a promising approach for patients who preferred nonpharmacological therapy.
- •This was the first study on the effect of tONS with different frequencies in China.
Abstract
This study's objective was to evaluate the efficacy and tolerability of transcutaneous
occipital nerve stimulation (tONS) in patients with migraine, and to explore whether
different tONS frequencies influenced treatment effectiveness. This was a randomized,
controlled trial of tONS for prevention of migraine. Patients were randomized to 1
of 5 therapeutic groups before treatment for 1 month. Groups A through C received
tONS at different frequencies (2 Hz, 100 Hz, and 2/100 Hz), group D underwent sham
tONS intervention, and group E received topiramate orally. The primary outcomes were
the 50% responder rate and headache characteristics. A total of 110 patients completed
the study. The 50% responder rate was significantly greater in the groups undergoing
active tONS and topiramate, compared with sham-treated group. A significant reduction
in headache intensity was noted in each test group compared with the sham group; the
groups undergoing tONS at different frequencies did not differ significantly. From
baseline to the 1-month treatment period, the tONS group with 100 Hz and topiramate
group exhibited significant decreases in headache duration. We conclude that tONS
therapy is a new promising approach for migraine prevention. It has infrequent and
mild adverse events and may be effective among patients who prefer nonpharmacological
treatment.
Perspective
This article introduces a randomized, controlled trial to illustrate tONS as a new
approach for prevention of migraine. It shows tONS is well tolerated and could be
considered as a promising treatment for patients who prefer to nonpharmacological
therapy.
Key words
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References
- A transcutaneous electrical nerve stimulation device (Cefaly) for migraine prevention.Med Lett Drugs Ther. 2014; 56: 78
- Central mechanisms of peripheral nerve stimulation in headache disorders.Prog Neurol Surg. 2011; 24: 16-26
- Cervicogenic headache: An assessment of the evidence on clinical diagnosis, invasive tests, and treatment.Lancet Neurol. 2009; 8: 959-968
- The influence of ictal cutaneous allodynia on the response to occipital transcutaneous electrical stimulation in chronic migraine and chronic tension-type headache: a randomized, sham-controlled study.Cephalalgia. 2015; 35: 389-398
- Topiramate 100 mg/day in migraine prevention: A pooled analysis of double-blind randomised controlled trials.Int J Clin Pract. 2015; 59: 961-968
- Development of opioid tolerance with repeated transcutaneous electrical nerve stimulation administration.Pain. 2003; 102: 195-201
- Topiramate reduces headache days in chronic migraine: A randomized, double-blind, placebo-controlled study.Cephalalgia. 2007; 27: 814-823
- New therapeutic approaches for the prevention and treatment of migraine.Lancet Neurol. 2015; 14: 1010-1022
- Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: A systematic analysis for the Global Burden of Disease Study 2013.Lancet. 2015; 386: 743-800
- Peripheral neuromodulation: A review.Curr Pain Headache Rep. 2014; 18: 412
- Acupuncture and endorphins.Neurosci Lett. 2004; 361: 258-261
- Effect of low- and high-frequency TENS on Met-enkephalin-Arg-Phe and dynorphin A immunoreactivity in human lumbar CSF.Pain. 1991; 47: 295-298
- The International Classification of Headache Disorders, 3rd edition (beta version).Cephalalgia. 2013; 33: 629-808
- Transcutaneous electrical nerve stimulation. Continuing Education in Anaesthesia.Critical Care & Pain. 2009; 9: 130-135
- Electrotherapy for neck pain.Cochrane Database Syst Rev. 2013; : CD004251
- Topiramate in patients with episodic migraine: Reducing the risk for chronic forms of headache.Headache. 2007; 47: 13-21
- Recent approaches and development of acupuncture on chronic daily headache.Curr Pain Headache Rep. 2016; 20: 4
- Neuromodulation in migraine: State of the art and perspectives.Exp Rev Med Devices. 2015; 12: 329-339
- Occipital nerve stimulation for drug-resistant chronic cluster headache: A prospective pilot study.Lancet Neurol. 2007; 6: 314-321
- Safety and patients’ satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly(R) device in headache treatment: A survey of 2,313 headache sufferers in the general population.J Headache Pain. 2013; 14: 95
- The effects of transcutaneous electrical nerve stimulation in patients with severe angina pectoris.Circulation. 1985; 71: 308-316
- European Headache Federation: Neuromodulation of chronic headaches: Position statement from the European Headache Federation.J Headache Pain. 2013; 14: 86
- Pain mechanisms: a new theory.Science. 1965; 150: 971-979
- Comparison of neurofeedback and transcutaneous electrical nerve stimulation efficacy on treatment of primary headaches: A randomized controlled clinical trial.Iran Red Crescent Med J. 2014; 16: e17799
- Comparison between efficacy of imipramine and transcutaneous electrical nerve stimulation in the prophylaxis of chronic tension-type headache: A randomized controlled clinical trial.J Res Med Sci. 2011; 16: 923-927
- Anticonvulsants in migraine prophylaxis: A Cochrane review.Cephalalgia. 2008; 28: 585-597
- Alternative headache treatments: Nutraceuticals, behavioral, and physical treatments.Headache. 2011; 51 (author reply: 1354): 1353
- The effects of peripheral occipital nerve stimulation for the treatment of patients suffering from chronic migraine: A single center experience.Pain Phys. 2014; 17: E369-E374
- Outcome of transcutaneous electrical nerve stimulation in chronic pain: Short-term results of a double-blind, randomised, placebo-controlled trial.J Headache Pain. 2006; 7: 196-205
- Clinical trials update 2014: Year in review.Headache. 2015; 55: 149-157
- Transcutaneous supraorbital neurostimulation in “de novo” patients with migraine without aura: The first Italian experience.J Headache Pain. 2015; 16: 69
- Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial.Neurology. 2013; 80: 697-704
- Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study.Neurology. 2016; 87: 529-538
- Guidelines for controlled trials of prophylactic treatment of chronic migraine in adults.Cephalalgia. 2008; 28 ([erratum in 28:679, 2008]): 484-495
- Occipital nerve stimulator placement via a retromastoid to infraclavicular approach: A technical report.Stereotact Funct Neurosurg. 2010; 88: 121-125
- Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: A systematic analysis for the Global Burden of Disease Study 2010.Lancet. 2012; 380: 2163-2196
- The prevalence and burden of primary headaches in China: A population-based door-to-door survey.Headache. 2012; 52: 582-591
Article info
Publication history
Published online: April 18, 2017
Accepted:
March 27,
2017
Received in revised form:
March 10,
2017
Received:
December 9,
2016
Footnotes
Trial registration: Chinese Clinical Trial Registry (ChiCTR-ONC-16008130); Registered March 22, 2016.
This work was supported by the National Scientific Research Fund (grant number 81471147).
The authors have no conflicts of interest to declare.
Identification
Copyright
© 2017 by the American Pain Society