Effectiveness of transcutaneous electrical nerve stimulation for the treatment of migraine: a meta-analysis of randomized controlled trials

Huimin Tao, Teng Wang, Xin Dong, Qi Guo, Huan Xu, Qi Wan, Huimin Tao, Teng Wang, Xin Dong, Qi Guo, Huan Xu, Qi Wan

Abstract

Background: Migraine is now ranked as the second most disabling disorder worldwide reported by the Global Burden of Disease Study 2016. As a noninvasive neurostimulation technique, transcutaneous electrical nerve stimulation(TENS) has been applied as an abortive and prophylactic treatment for migraine recently. We conduct this meta-analysis to analyze the effectiveness and safety of TENS on migraineurs.

Methods: We searched Medline (via PubMed), Embase, the Cochrane Library and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials, which compared the effect of TENS with sham TENS on migraineurs. Data were extracted and methodological quality assessed independently by two reviewers. Change in the number of monthly headache days, responder rate, painkiller intake, adverse events and satisfaction were extracted as outcome.

Results: Four studies were included in the quantitative analysis with 161 migraine patients in real TENS group and 115 in sham TENS group. We found significant reduction of monthly headache days (SMD: -0.48; 95% CI: -0.73 to - 0.23; P < 0.001) and painkiller intake (SMD: -0.78; 95% CI: -1.14 to - 0.42; P < 0.001). Responder rate (RR: 4.05; 95% CI: 2.06 to 7.97; P < 0.001) and satisfaction (RR: 1.85; 95% CI: 1.31 to 2,61; P < 0.001) were significantly increased compared with sham TENS.

Conclusion: This meta-analysis suggests that TENS may serve as an effective and well-tolerated alternative for migraineurs. However, low quality of evidence prevents us from reaching definitive conclusions. Future well-designed RCTs are necessary to confirm and update the findings of this analysis.

Systematic review registration: Our PROSPERO protocol registration number: CRD42018085984 . Registered 30 January 2018.

Keywords: Meta-analysis; Migraine; TENS; Transcutaneous electrical nerve stimulation.

Conflict of interest statement

Ethics approval and consent to participate

Not applicable.

Consent for publication

All authors have read and approved the manuscript for publication.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram of studies. Process of identifying eligible studies for the meta-analysis
Fig. 2
Fig. 2
Risk of bias summery for included trials
Fig. 3
Fig. 3
Change in the number of monthly headache days. Forest plot of the meta-analysis showed a significant decrease in the number of monthly headache days after therapy with TENS compared with sham TENS
Fig. 4
Fig. 4
Change in the number of monthly headache days (sensitivity analysis). Sensitivity analysis showed that heterogeneity was most likely because of the study by Li et al., without which the heterogeneity reduced to zero with little change to the summary estimate
Fig. 5
Fig. 5
Responder rate. Forest plot of the meta-analysis showed significant increase in 50% responder rate after therapy with TENS compared with sham TENS
Fig. 6
Fig. 6
Painkiller intake. Forest plot of the meta-analysis showed a significant decrease in the number of painkiller intake after therapy with TENS compared with sham TENS
Fig. 7
Fig. 7
Satisfaction. Forest plot of the meta-analysis showed a significant increase in satisfaction after therapy with TENS compared with sham TENS
Fig. 8
Fig. 8
Quality of evidence assessment. Quality of evidence assessment for pain control outcomes performed by GRADE profiler

References

    1. GBD Disease, injury incidence, prevalence collaborators (2017) global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the global burden of disease study 2016. Lancet. 2016;390(10100):1211–1259.
    1. Akerman S, Romero-Reyes M, Holland PR. Current and novel insights into the neurophysiology of migraine and its implications for therapeutics. Pharmacol Ther. 2017;172:151–170. doi: 10.1016/j.pharmthera.2016.12.005.
    1. Kristoffersen ES, Lundqvist C. Medication-overuse headache: epidemiology, diagnosis and treatment. Ther Adv Drug Saf. 2014;5(2):87–99. doi: 10.1177/2042098614522683.
    1. Johnson MI, Paley CA, Howe TE, Sluka KA. Transcutaneous electrical nerve stimulation for acute pain. Cochrane Database Syst Rev. 2015;6:CD006142.
    1. Peroutka SJ. Clinical trials update 2014: year in review. Headache. 2015;55(1):149–157. doi: 10.1111/head.12479.
    1. Gaul C, Diener HC, Silver N, Magis D, Reuter U, Andersson A, Liebler EJ, Straube A, Group PS Non-invasive vagus nerve stimulation for PREVention and acute treatment of chronic cluster headache (PREVA): a randomised controlled study. Cephalalgia. 2016;36(6):534–546. doi: 10.1177/0333102415607070.
    1. Kinfe TM, Pintea B, Muhammad S, Zaremba S, Roeske S, Simon BJ, Vatter H. Cervical non-invasive vagus nerve stimulation (nVNS) for preventive and acute treatment of episodic and chronic migraine and migraine-associated sleep disturbance: a prospective observational cohort study. J Headache Pain. 2015;16:101. doi: 10.1186/s10194-015-0582-9.
    1. Barbanti P, Grazzi L, Egeo G, Padovan AM, Liebler E, Bussone G. Non-invasive vagus nerve stimulation for acute treatment of high-frequency and chronic migraine: an open-label study. J Headache Pain. 2015;16:61. doi: 10.1186/s10194-015-0542-4.
    1. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535. doi: 10.1136/bmj.b2535.
    1. Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA, Cochrane Bias Methods G, Cochrane Statistical Methods G. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928. doi: 10.1136/bmj.d5928.
    1. Higgins J, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 Wiley-Blackwell,2011:102–8. 2011.
    1. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327(7414):557–560. doi: 10.1136/bmj.327.7414.557.
    1. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schunemann HJ, Group GW GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924–926. doi: 10.1136/.
    1. Bono F, Salvino D, Mazza MR, Curcio M, Trimboli M, Vescio B, Quattrone A. 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(5):389–398. doi: 10.1177/0333102414544909.
    1. Schoenen J, Vandersmissen B, Jeangette S, Herroelen L, Vandenheede M, Gerard P, Magis D. Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology. 2013;80(8):697–704. doi: 10.1212/WNL.0b013e3182825055.
    1. Silberstein SD, Calhoun AH, Lipton RB, Grosberg BM, Cady RK, Dorlas S, Simmons KA, Mullin C, Liebler EJ, Goadsby PJ, Saper JR, Group ES Chronic migraine headache prevention with noninvasive vagus nerve stimulation: the EVENT study. Neurology. 2016;87(5):529–538. doi: 10.1212/WNL.0000000000002918.
    1. Liu Y, Dong Z, Wang R, Ao R, Han X, Tang W, Yu S. Migraine prevention using different frequencies of transcutaneous occipital nerve stimulation: a randomized controlled trial. J Pain. 2017;18(8):1006–1015. doi: 10.1016/j.jpain.2017.03.012.
    1. Li H, Xu QR. Effect of percutaneous electrical nerve stimulation for the treatment of migraine. Medicine (Baltimore) 2017;96(39):e8108. doi: 10.1097/MD.0000000000008108.
    1. Dechartres A, Trinquart L, Boutron I, Ravaud P. Influence of trial sample size on treatment effect estimates: meta-epidemiological study. BMJ. 2013;346:f2304. doi: 10.1136/bmj.f2304.
    1. Gibson W, Wand BM, O'Connell NE. Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults. Cochrane Database Syst Rev. 2017;9:CD011976.
    1. Treede RD. Gain control mechanisms in the nociceptive system. Pain. 2016;157(6):1199–1204. doi: 10.1097/j.pain.0000000000000499.
    1. Robbins MS, Lipton RB. Transcutaneous and percutaneous Neurostimulation for headache disorders. Headache. 2017;57 Suppl 1:4–13. doi: 10.1111/head.12829.
    1. Yuan H, Silberstein SD. Vagus nerve and Vagus nerve stimulation, a comprehensive review: part III. Headache. 2016;56(3):479–490. doi: 10.1111/head.12649.
    1. Oshinsky ML, Murphy AL, Hekierski H, Jr, Cooper M, Simon BJ. Noninvasive vagus nerve stimulation as treatment for trigeminal allodynia. Pain. 2014;155(5):1037–1042. doi: 10.1016/j.pain.2014.02.009.
    1. Chen SP, Ay I, de Morais AL, Qin T, Zheng Y, Sadeghian H, Oka F, Simon B, Eikermann-Haerter K, Ayata C. Vagus nerve stimulation inhibits cortical spreading depression. Pain. 2016;157(4):797–805. doi: 10.1097/j.pain.0000000000000437.
    1. Magis D, D'Ostilio K, Thibaut A, De Pasqua V, Gerard P, Hustinx R, Laureys S, Schoenen J. Cerebral metabolism before and after external trigeminal nerve stimulation in episodic migraine. Cephalalgia. 2017;37(9):881–891. doi: 10.1177/0333102416656118.
    1. Ahmed HE, White PF, Craig WF, Hamza MA, Ghoname ES, Gajraj NM. Use of percutaneous electrical nerve stimulation (PENS) in the short-term management of headache. Headache. 2000;40(4):311–315. doi: 10.1046/j.1526-4610.2000.00046.x.
    1. Heidland A, Fazeli G, Klassen A, Sebekova K, Hennemann H, Bahner U, Di Iorio B. Neuromuscular electrostimulation techniques: historical aspects and current possibilities in treatment of pain and muscle waisting. Clin Nephrol. 2013;79(Suppl 1):S12–S23.
    1. Rakel B, Cooper N, Adams HJ, Messer BR, Law LAF, Dannen DR, Miller CA, Polehna AC, Ruggle RC, Vance CGT. A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment. J Pain Official J Am Pain Soc. 2010;11(3):230. doi: 10.1016/j.jpain.2009.07.007.
    1. Sluka KA, Bjordal JM, Marchand S, Rakel BA. What makes transcutaneous electrical nerve stimulation work? Making sense of the mixed results in the clinical literature. Phys Ther. 2013;93(10):1397–1402. doi: 10.2522/ptj.20120281.
    1. Chou DE, Gross GJ, Casadei CH, Yugrakh MS. External trigeminal nerve stimulation for the acute treatment of migraine: open-label trial on safety and efficacy. Neuromodulation. 2017;20(7):678–683. doi: 10.1111/ner.12623.
    1. Grazzi L, Egeo G, Liebler E, Padovan AM, Barbanti P. Non-invasive vagus nerve stimulation (nVNS) as symptomatic treatment of migraine in young patients: a preliminary safety study. Neurol Sci. 2017;38(1):197–199. doi: 10.1007/s10072-017-2942-5.
    1. Russo A, Tessitore A, Conte F, Marcuccio L, Giordano A, Tedeschi G. Transcutaneous supraorbital neurostimulation in "de novo" patients with migraine without aura: the first Italian experience. J Headache Pain. 2015;16:69. doi: 10.1186/s10194-015-0551-3.
    1. Straube A, Ellrich J, Eren O, Blum B, Ruscheweyh R. Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. J Headache Pain. 2015;16:543. doi: 10.1186/s10194-015-0543-3.
    1. Vikelis M, Dermitzakis EV, Spingos KC, Vasiliadis GG, Vlachos GS, Kararizou E. Clinical experience with transcutaneous supraorbital nerve stimulation in patients with refractory migraine or with migraine and intolerance to topiramate: a prospective exploratory clinical study. BMC Neurol. 2017;17(1):97. doi: 10.1186/s12883-017-0869-3.

Source: PubMed

3
Předplatit