Treatment of migraine attacks by transcutaneous electrical nerve stimulation in emergency department: A randomize controlled trial

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Abstract

Purpose

The primary purpose of this trial is to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) therapy application in the emergency department.

Methods

The patients were divided into 2 groups: a sham group, and a verum group. Patients in the verum group include those who use the device for the first time. Both groups were connected to visually indistinguishable devices. Both groups underwent therapy for a total of 20 min. Using the Visual Analog Scale (VAS), the patients' perceived changes in pain intensity were recorded at the 20th and 120th minutes after initiation therapy. After the 120th minute, patients' individual needs for additional treatment were assessed. Additionally, their self-reported well-being was assessed using a Likert-type verbal scale.

Results

In total 151 patients that were admitted to the emergency ward were assessed, with the sham and verum group being assigned 39 patients each from this pool. For the verum group the VAS change from 0 to 120 min was −65 ± 25 and for the sham group it was −9 ± 2 (p < 0.001). Verbal scores in the 120th minute were found to be 1.2 for sham group and 4.5 in the verum group (p < 0.001). Thirty patients (76.92%) in the sham group and 1 (2%) in the verum group had additional analgesic requirement after 120 min.

Conclusion

TENS therapy is a fast-acting, effective therapy for the treatment of acute migraine in the emergency department.

Introduction

Migraine is a type of primary headache that can be a major impairment to quality of life [1]. This disease has been found to be the 3rd most common globally, and the 7th most common debilitating disease [2]. Migraine typically presents as a middling or severe, unilateral, pulsatile headache that last between 4 and 72 h. This condition may be accompanied by nausea and/or photophobia and phonophobia [1]. Treatments for migraine conventionally aim to alleviate symptoms. There are two main groups of migraine treatments: preventative treatments and symptomatic treatments. Available treatment options generally have unwanted side effects and are not effective in some patients [3]. The most effective treatment options have success rates under 50%, and for chronic forms of migraine this proportion is even lower [4]. The incidence of suicide in migraine patients has been found to be higher than in the general population [5]. Migraine patients are often admitted to the emergency ward. For this reason, the development or discovery of an effective and cheap treatment option for use in the emergency department can be of great value in the management of this disease.

Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive analgesic technique used in the treatment of nociceptive, neuropathic, and musculo-skeletal pain [6]. This therapy uses a non-invasive, self-administered device. This device delivers electrical current that causes peripheral nerve activation and consequently provides an analgesic effect. The electrical current is supplied through a portable device during therapy, and the current is delivered to the skin via electrodes. Rigorous neurophysiological evidence shows that this device inhibits the central nervous system's nociceptive signal transmission [7,8]. In fact, TENS therapy has been shown in the literature to have a sedative effect on healthy individuals [9]. Studies which evaluate TENS' effectiveness in treating acute migraine attacks suggest that this therapy may be beneficial.

The purpose of this study was to evaluate the TENS protocol's effectiveness in treating acute migraine in the emergency department.

Section snippets

Study design

This was a prospective, double-blinded, randomized controlled trial (RCT) conducted at the Emergency Department of Kartal Dr. Lütfi Kirdar Training and Research Hospital in İstanbul, Turkey.

The study was approved by the ethics committee at Kartal Dr. Lütfi Kirdar Training and Research Hospital in İstanbul, Turkey (Ethics Committee Ruling number: 2019/514/156/3). All participating patients signed an informed consent form. All authors had full access to all study data.

Study population

Patients admitted to the

Characteristics of study subjects

During the planned 5 month study period between June 2019 and October 2019, a total of 151 patients were deemed eligible for the trial based on inclusion/exclusion criteria. Of these patients, 33 ceased to meet the inclusion criteria, 23 patients declined to participate, and 12 patients were excluded due to other reasons (e.g. consumption of alcohol/cannabinoids in the 24 h preceding admission). The remaining 83 patients were assigned to groups. Of the patients assigned to groups, 3 subjects

Limitations

Despite adequate provision of information, our trial was extended due to emergency department patients' agitation at time of admission, addiction to frequently used injectable treatments, and a general avoidance of electrical treatments. Better public education about these treatment modalities may lead to a reduction in prejudice and allow these treatment options to be used more frequently. Also we did not use an intention to treat analysis as there were only a few patients that dropped out

Discussion

This prospective, randomized, controlled, double blinded trial investigates the effectiveness of TENS therapy in treating acute migraine in the emergency department. The trial aims to evaluate the results of treatment of acute migraine in the emergency department at the 20th and 120th minute after initiation of treatment. No treatment-related skin reactions or unwanted effects were encountered during the trial. Of the verum group, 3 patients declined continuation of treatment due to intolerance

Conclusion

TENS therapy is an effective and economical treatment with few side effects and may be used in the emergency department for treatment of acute migraine episodes.

Source of support

This study was supported by Kartal Dr. Lütfi Kirdar Training and Research Hospital. The research did not receive any financial support from any public or private organization. During the conduct of the study, written permission was obtained from WAT-MED company for the use of HeadaTerm TENS device and its documentation.

Meetings

The study was not published anywhere or presented as an oral paper.

Authors' contributions

NMH: Conceptualization, Methodology, Software, and Writing - reviewing and editing, MOE: Writing - Original draft preparation, Supervision, UDH: Supervision, Writing - reviewing and editing, AA: Investigation, Data curation DT: Software, Validation. AUS: Investigation, Validation. All authors had access to the manuscript at every stage of the preparation. They approved the upload of the manuscript all together.

Consent for publication

Written consent forms have taken from each patient. Also for using or publishing data about HeadaTerm TENS device written permission letter taken from WAT-MED.

Availability of data and material

The datasets used and/or analyzed during the current study are open from the corresponding author on reasonable request.

Funding

The research has not taken any kind of funding from public or private companies.

Declaration of competing interest

The author(s) declare(s) that they have no competing interests.

Acknowledgements

We are thankful to Mr. Murat Soylemez (general secretary of hospital's emergency department) who has supported us about data analysis during the study. We would also like to thank Lewis Aaron Mepham for his contribution in reviewing the English version of the manuscript.

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