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Randomized Controlled Trial
Analgesic efficacy of a portable, disposable, and self-applied transcutaneous electrical nerve stimulation device during migraine attacks: a real-life randomized controlled trial.
- Flávia S Domingues, Maisa V Gayoso, Shafaq Sikandar, da SilvaLeopoldo MunizLMAnesthesiology Department (CMA), São Luiz Hospital, Rede D'or, São Paulo, Brazil., Ronaldo G Fonseca, and Guilherme A M de Barros.
- Surgical Specialties and Anesthesiology Department, Medical School, Sao Paulo State University (UNESP), Botucatu, Brazil.
- Pain Pract. 2021 Nov 1; 21 (8): 850858850-858.
ObjectiveThe objective of this study was to evaluate the analgesic efficacy of a portable, disposable, and home self-applied transcutaneous electrical nerve stimulation (TENS) device during migraine attacks.BackgroundTENS has been used as a noninvasive treatment for migraine, but there are no reports on the outcomes following use of this treatment option for use at home during migraine attacks.Design And MethodsA double-blind, randomized controlled trial was conducted over 3 months, with monthly assessments. Active placebos (sham group) were in place and were allocated at a 1:1 ratio. Adult patients who had been diagnosed with migraine by a specialist were included. Pain intensity levels and functional disability were measured before and after the 20-min self-applied TENS intervention during the migraine attacks.ResultsSeventy-four participants were randomly allocated to the sham and intervention groups. Although both groups of subjects reported lower pain scores, the intervention group showed a statistically significant reduction in pain scores compared to the sham group.ConclusionIn our controlled trial, the use of a self-applied, TENS device is safe and effective in relieving pain associated with migraine attacks. Participants in the intervention group showed a statistically significant improvement in pain and functional disability scores. TENS has been used as a noninvasive treatment for migraine, but there are no reports on the outcomes following use of this treatment option for use at home during migraine attacks. This double-blind, randomized controlled trial had 2 groups: active-placebo and intervention. Seventy-four participants were randomly allocated. Participants in the intervention group showed a statistically significant improvement in pain and functional disability scores.© 2021 World Institute of Pain.
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