Manual acupuncture as prophylaxis for migraine without aura: study protocol for a multi-center, randomized, single-blinded trial

Abstract

Background Migraine is a highly prevalent neurological disorder. It is the third most prevalent disorder and the seventh highest cause of disability worldwide. Acupuncture may be a viable prophylactic treatment option for frequent or uncontrolled migraine. Clinical studies comparing acupuncture and placebo acupuncture have not reached a consistent conclusion in confirming whether acupuncture is effective in migraine prophylaxis. The effect of acupuncture mainly depends on acupoints and needles operation. We found that the design of the placebo acupuncture in previous studies included shallow needling at sham acupoints, non-penetrating needling at sham acupoints, and needling at inactive acupuncture points to achieve the inert effect of control group, but the non-penetrating needling at true acupoints was ignored. This randomized controlled trial aims to use true acupoints for non-penetrating acupuncture as control to evaluate the efficacy of manual acupuncture for the prophylaxis of migraine without aura (MWoA). Methods/design This is a single-blinded, randomized, controlled, prospective, multi-center trial with two parallel treatment groups. A total of 198 eligible patients with MWoA will be randomly divided into two groups (1:1 allocation ratio). The intervention group will receive manual acupuncture and the control group will receive placebo acupuncture (non-penetrating). Patients will receive three acupuncture treatment sessions per week for 4 consecutive weeks. All patients will then receive a 12-week follow-up. Discussion In this study, we are evaluating the efficacy and safety of manual acupuncture in the prophylaxis of MWoA. The placebo control is using non-penetrating needling verum acupoints. It is essential to determine an appropriate control method to ensure the methodological quality of a randomized controlled trial. Trial registration The trial has been registered in the Chinese Clinical Trial Registry (approval no. ChiCTR2000032308) in April 2020.

Circulating exosomal microRNA profiles in migraine patients receiving acupuncture treatment: A placebo-controlled clinical trial

“…The trAMWoA group and HCs received TA treatment, while the shAMWoA group received SA treatment. Both TA and SA treatments were conducted according to a previously published protocol ( Chen et al, 2022 ) and performed by experienced physicians with more than 5 years of clinical experience in acupuncture treatment. The acupoint prescriptions, acupoint localization, acupoint selection, and insertion depth were described in detail in our previous study ( Zhao et al, 2017 ; Chen et al, 2022 ).…”

Research Progress of Acupuncture Analgesia Based on Autonomic Nerve Regulation Pathway

“…Migraine [14,[73][74] GV20, GB8 GB20, SI17 Sympathetic Decreasing heart rate variability low-frequency power to relieve pain Irritable bowel syndrome [75][76] DU20, EX-HN3, ST36, ST37, SP6, ST25, LR3…”

“…Acupuncture has been clinically proven to relieve migraine and autonomic symptoms [85] . Acupuncture at Baihui (GV20), Shuaigu (GB8), Fengchi (GB20), Tianrong (SI17), and other points can reduce sympathetic nerve activity, reduce heart rate variability low-frequency power, and relieve pain in migraine patients [14,73–74] .…”

Acupuntura Na Profilaxia Da Enxaqueca Sem Aura Comparada Com a Terapia Farmacológica: Uma Revisão Sistemática

“…Essa terapia de origem chinesa vem sendo usada há mais de 3000 anos no controle de sintomas, tratamento de doenças e, principalmente, no alívio da dor e seu objetivo, inicialmente, era trazer o paciente de volta ao estado de equilíbrio antes da doença. Atualmente, sabe-se que essa terapia tem diversos efeitos de curto e longo prazo em uma variedade de variáveis fisiológicas de importância para a analgesia, onde uma combinação de efeitos locais, mecanismos epinais, supraespinais, corticais e psicológicos contribuem para sua efetividade (Chen et al, 2022).…”