Efficacy and Feasibility of an Integrated Yoga Module as Add-On Therapy for Primary Headache: A Pilot Randomized Controlled Trial

Abstract

Background. Primary headache disorders, principally migraine and tension-type headache, are among the leading causes of disability worldwide, and a substantial proportion of patients remain dissatisfied with pharmacologic management alone. Integrated yoga has shown promise as an adjuvant therapy, but evidence from controlled trials remains limited. Objective. To evaluate the effect of a validated, 60-minute integrated yoga therapy module, delivered in a hybrid (online and offline) format as an add-on to conventional medical management, on pain, headache burden, psychological distress, sleep, quality of life, and analgesic use in adults with primary headache. Methods. In this single-centre, parallel-group randomized controlled trial, 40 adults (aged 20–70 years) with a clinical diagnosis of primary headache were randomly allocated 1:1 to Group 1 (integrated yoga module plus conventional medical management; n = 20) or Group 2 (conventional medical management alone; n = 20). Outcomes were assessed at baseline and at 3 months using the Visual Analogue Scale (VAS), monthly headache frequency, HIT-6, MIDAS, the Perceived Stress Scale (PSS), the Insomnia Severity Index (ISI), the WHOQOL-BREF, and a 30-day rescue-pill count. Within-group change was assessed by paired-samples t-tests and between-group difference by independent-samples t-tests. Results. The groups were demographically comparable at baseline (sex: χ² = 1.026, p = .311; age group: χ² = 3.796, p = .434). Group 1 improved significantly on all eight outcomes (all p < .001); pain (VAS) fell from 8.40 to 2.65, and rescue-pill count from 60.0 to 30.5. Group 2 also improved on most outcomes, but the gains were generally smaller, and the change in HIT-6 was not significant (p = .267). At 3 months, Group 1 was significantly superior to Group 2 for pain (p < .001), HIT-6 (p = .003), MIDAS (p < .001), insomnia (p = .003), and rescue-pill use (p < .001); the groups did not differ significantly on headache frequency, perceived stress, or quality of life. Conclusions. Adding a validated 60-minute integrated yoga module to conventional care produced clinically meaningful improvements across pain, headache impact, disability, sleep, and analgesic use, and was superior to medical management alone on several key outcomes. A hybrid delivery model appears feasible and may broaden access to yoga-based adjuvant therapy for primary headache. Findings should be interpreted cautiously, given the small sample and single-centre design.