Evaluating the effects of a validated yoga module on migraine burden and neurovascular biomarkers: Study protocol for a randomised controlled trial.

BACKGROUND

Migraines rank among the most prevalent neurological disorders worldwide, causing severe functional impairment, predominantly affecting young adults, especially women. Despite pharmacological progress, many individuals continue to experience recurrent attacks, comorbidities, and medication complications, highlighting the need for integrative approaches. Yoga has shown potential benefits in migraine management; however, evidence from rigorous trials using validated migraine-specific modules remains limited.

AIM: The trial investigates the effectiveness of a new yoga module as a complementary treatment for migraine symptoms alongside standard medication.

METHODS

This single-blind, two-arm randomised controlled trial will recruit 82 participants with migraine per ICHD-3 criteria. Participants will be randomly allocated (1:1) to either a yoga intervention group or a waitlist control group using permuted-block randomisation with sealed-envelope allocation concealment. Outcome assessors will remain blinded. The intervention group will receive a scientifically developed and validated migraine-specific yoga module for 45 min/day, 5 days/week, for 12 weeks, while the control group will continue usual care. Primary outcomes include headache frequency, pill count, pain intensity, migraine-specific quality of life (MSQ v2.1), and calcitonin gene-related peptide (CGRP). Secondary outcomes include endothelial nitric oxide synthase (eNOS), high-sensitivity C-reactive protein (hs-CRP), red cell distribution width (RDW), migraine interictal burden (MIBS-4), and sleep quality (SATED). Assessments will be conducted at baseline and post-intervention.

CONCLUSION

This trial will evaluate the effectiveness of a validated migraine-specific yoga intervention on clinical, biochemical, and quality-of-life outcomes. The findings may provide evidence supporting yoga as an integrative adjunctive therapy for migraine management.

TRIAL REGISTRATION: CTRI/2025/08/092156 (ctri.gov.in).