scholarly journals Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial

Cephalalgia ◽  
2018 ◽  
Vol 39 (1) ◽  
pp. 3-14 ◽  
Author(s):  
Denise E Chou ◽  
Marianna Shnayderman Yugrakh ◽  
Dana Winegarner ◽  
Vernon Rowe ◽  
Deena Kuruvilla ◽  
...  

Objective To assess the safety and efficacy of external trigeminal nerve stimulation for acute pain relief during migraine attacks with or without aura via a sham-controlled trial. Methods This was a double-blind, randomized, sham-controlled study conducted across three headache centers in the United States. Adult patients who were experiencing an acute migraine attack with or without aura were recruited on site and randomly assigned 1:1 to receive either verum or sham external trigeminal nerve stimulation treatment (CEFALY Technology) for 1 hour. Pain intensity was scored using a visual analogue scale (0 = no pain to 10 = maximum pain). The primary outcome measure was the mean change in pain intensity at 1 hour compared to baseline. Results A total of 109 participants were screened between February 1, 2016 and March 31, 2017. Of these, 106 patients were randomized and included in the intention-to-treat analysis (verum: n = 52; sham: n = 54). The primary outcome measure was significantly more reduced in the verum group than in the sham group: −3.46 ± 2.32 versus −1.78 ± 1.89 ( p < 0.0001), or −59% versus −30% ( p < 0.0001). With regards to migraine subgroups, there was a significant difference in pain reduction between verum and sham for ‘migraine without aura’ attacks: mean visual analogue scale reduction at 1 hour was −3.3 ± 2.4 for the verum group versus −1.7 ± 1.9 for the sham group ( p = 0.0006). For ‘migraine with aura’ attacks, pain reduction was numerically greater for verum versus sham, but did not reach significance: mean visual analogue scale reduction at 1 hour was −4.3 ± 1.8 for the verum group versus −2.6 ± 1.9 for the sham group ( p = 0.060). No serious adverse events were reported and five minor adverse events occurred in the verum group. Conclusion One-hour treatment with external trigeminal nerve stimulation resulted in significant headache pain relief compared to sham stimulation and was well tolerated, suggesting it may be a safe and effective acute treatment for migraine attacks. Study protocol ClinicalTrials.gov Identifier: NCT02590939.

2020 ◽  
Vol 13 (5) ◽  
pp. 1245-1253
Author(s):  
Francisco Gil-López ◽  
Teresa Boget ◽  
Isabel Manzanares ◽  
Antonio Donaire ◽  
Estefanía Conde-Blanco ◽  
...  

Neurology ◽  
2013 ◽  
Vol 80 (9) ◽  
pp. 786-791 ◽  
Author(s):  
C. M. DeGiorgio ◽  
J. Soss ◽  
I. A. Cook ◽  
D. Markovic ◽  
J. Gornbein ◽  
...  

Cephalalgia ◽  
2016 ◽  
Vol 37 (9) ◽  
pp. 881-891 ◽  
Author(s):  
Delphine Magis ◽  
Kevin D’Ostilio ◽  
Aurore Thibaut ◽  
Victor De Pasqua ◽  
Pascale Gerard ◽  
...  

Background and aim A recent sham-controlled trial showed that external trigeminal nerve stimulation (eTNS) is effective in episodic migraine (MO) prevention. However, its mechanism of action remains unknown. We performed 18-fluorodeoxyglucose positron emission tomography (FDG-PET) to evaluate brain metabolic changes before and after eTNS in episodic migraineurs. Methods Twenty-eight individuals were recruited: 14 with MO and 20 healthy volunteers (HVs). HVs underwent a single FDG-PET, whereas patients were scanned at baseline, directly after a first prolonged session of eTNS (Cefaly®) and after three months of treatment (uncontrolled study). Results The frequency of migraine attacks significantly decreased in compliant patients ( N = 10). Baseline FDG-PET revealed a significant hypometabolism in fronto-temporal areas, especially in the orbitofrontal (OFC) and rostral anterior cingulate cortices (rACC) in MO patients. This hypometabolism was reduced after three months of eTNS treatment. Conclusion Our study shows that metabolic activity of OFC and rACC, which are pivotal areas in central pain and behaviour control, is decreased in migraine. This hypometabolism is reduced after three months of eTNS. eTNS might thus exert its beneficial effects via slow neuromodulation of central pain-controlling areas, a mechanism also previously reported in chronic migraine and cluster headache after percutaneous occipital nerve stimulation. However, this finding needs to be confirmed by further studies using a sham condition.


2018 ◽  
pp. 70-78
Author(s):  
Ninik Maathia Sallatalohy ◽  
Mauren J Paliyama ◽  
Farah Ch Noya

Pendahuluan. Nyeri Punggung Bawah (NPB) merupakan suatu permasalahan yang paling sering ditemukan di masyarakat. Etiologinya tergolong kompleks dan dapat disebabkan oleh berbagai hal. Salah satu pilihan penatalaksanaan NPB adalah dengan terapi TENS. Tujuan. Tujuan penelitian ini adalah untuk mengetahui efektifitas terapi TENS pada pasien NPB di RSUD dr. M Haulussy Ambon. Metode. Desain penelitian yang digunakan adalah pretest–posttest design, dengan mengukur skala Visual Analogue Scale (VAS) sebelum dan setelah 5 kali terapi TENS. Jumlah subjek yang memenuhi kriteria sebanyak 71 dengan perbandingan laki-laki dan perempuan adalah 1:2. Hasil. Hasil uji Marginal Homogenity memperlihatkan perbedaan signifikansi sebelum dan setelah 5 kali terapi TENS (p = 0,000). Kesimpulan. TENS efektif dalam meredakan nyeri pada pasien NPB. Kata Kunci: Nyeri Punggung Bawah, TENS


Author(s):  
I Rezaei ◽  
M Razeghi ◽  
S Ebrahimi ◽  
S Kayedi ◽  
A Rezaeian Zadeh

Background: Despite the potential benefits of virtual reality technology in physical rehabilitation, only a few studies have evaluated the efficacy of this type of treatment in patients with neck pain.Objective: The aim of this study was to compare the effects of virtual reality training (VRT) versus conventional proprioceptive training (CPT) in patients with neck pain.Methods: Forty four participants with nonspecific chronic neck pain were randomly assigned to VRT or CPT in this assessor-blinded clinical trial. A novel videogame called Cervigame® was designed for VRT. It comprises of 50 stages divided into unidirectional and two-directional stages ordered from easy to hard. CPT consisted of eye-follow, gaze stability, eye-head coordination and position and movement sense training. Both groups completed 8 training sessions over 4 weeks. Visual analogue scale score, neck disability index and Y-balance test results were recorded at baseline, immediately after and 5 weeks post-intervention. Mixed repeated measure ANOVA was used to analyze differences between mean values for each variable at an alpha level of 0.05.Results: There were significant improvements in all variables in both groups immediately after and 5 weeks after the intervention. Greater improvements were observed in the visual analogue scale and neck disability index scores in VRT group, and the results for all directions in Y-balance test were similar in both groups. No side effects were reported.Conclusion: Improvements in neck pain and disability were greater in VRT than CPT group. Cervigame® is a potentially practical tool for rehabilitation in patients with neck pain.


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