Currently submitted to: JMIR Research Protocols
Date Submitted: Jan 1, 2026
Open Peer Review Period: Jan 7, 2026 - Mar 4, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Evaluation of comparative efficacy of Transcutaneous Auricular Vagal Nerve Stimulation with conventional physiotherapy as against Transcutaneous Supra-orbital Nerve Stimulation with conventional physiotherapy in the management of migraine: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Migraine is a common and disabling neurological disorder characterized by recurrent headaches and associated symptoms that significantly affect quality of life. Conventional physiotherapy plays a supportive role in migraine management; however, it may not adequately address central sensitization and altered pain modulation. Non-invasive neuromodulation techniques such as transcutaneous auricular vagal nerve stimulation (ta-VNS) and transcutaneous supraorbital nerve stimulation (t-SNS) have shown potential in modulating central pain pathways and reducing migraine burden.
Objective:
The primary objective of this study is to evaluate and compare the effectiveness of ta-VNS and t-SNS, each combined with conventional physiotherapy, in reducing pain intensity and migraine frequency, incidence in individuals with migraine. Secondary objectives include assessing their effects on migraine disability, neck disability, and cervical range of motion.
Methods:
This randomized controlled trial will include individuals clinically diagnosed with migraine. Participants will be randomly allocated into two groups: Group A will receive ta-VNS along with conventional physiotherapy, and Group B will receive t-SNS along with conventional physiotherapy. Both interventions will be administered for a defined treatment period. Outcome measures will be recorded at baseline, immediately post-intervention, and during follow-up periods to evaluate short- and long-term effects.
Results:
It is anticipated that both ta-VNS and t-SNS, when combined with conventional physiotherapy, will lead to significant improvements in pain intensity, migraine frequency, and functional outcomes. One neuromodulation technique may demonstrate superior or more sustained benefits over the other.
Conclusions:
This study is expected to provide comparative evidence on the effectiveness of ta-VNS and t-SNS as adjuncts to conventional physiotherapy in migraine management. The findings may support the inclusion of targeted non-invasive neuromodulation techniques in physiotherapy-based treatment protocols for migraine. Clinical Trial: Ctri registration- CTRI/2026/01/100045
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