Efficacy of Combining Conventional Physiotherapy for Migraine With Transcutaneous Stimulation of the Auricular Vagal Nerve or Supraorbital Nerve: Protocol for a Randomized Controlled Trial (Preprint)

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. Noninvasive 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 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 2 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 after the 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 greater or more sustained benefits than 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 noninvasive neuromodulation techniques in physiotherapy-based treatment protocols for migraine. CLINICALTRIAL Clinical Trials Registry–India CTRI/2026/01/100045; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTQ3Mjgz&Enc=&userName= INTERNATIONAL REGISTERED REPORT DERR1-10.2196/90669