Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine (MIGRANE-YOGA)

A Randomized Controlled Trial of an Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine

This randomized controlled trial aims to evaluate the effectiveness and feasibility of an online Hatha yoga program as an adjunct (add-on) therapy for patients with high-frequency episodic migraine. Participants will be randomly assigned to either an intervention group receiving a 12-week home-based online Hatha yoga program in addition to usual pharmacological treatment, or a control group receiving usual pharmacological care only. Outcomes include migraine frequency, pain intensity, functional disability, sleep quality, psychological symptoms, and adherence.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Other: Hatha yoga; Other: Control group (receiving standard medical therapy alone)

Detailed Description

This study is designed as a randomized controlled clinical trial with a parallel-group add-on design. The objective is to evaluate a non-pharmacological intervention based on an online Hatha yoga program in patients diagnosed with high-frequency episodic migraine according to ICHD criteria.

Participants will be recruited from the Headache Unit of the Virgen del Rocío University Hospital and a primary care center in Seville, Spain. After screening and informed consent, participants will be randomly assigned (1:1) to either the intervention or control group.

The intervention group will receive a 12-week home-based asynchronous online Hatha yoga program (two sessions per week, 30-45 minutes each), in addition to their usual stable pharmacological treatment. The control group will continue usual pharmacological care without structured exercise intervention.

Primary outcomes include migraine frequency, pain intensity (VAS), and functional impact (HIT-6 and MIDAS). Secondary outcomes include sleep quality (PSQI), psychological symptoms (HADS), physical activity (GPAQ), global patient impression of change (PGIC), and adherence measures (EARS and PADEX).

Assessments will be conducted at baseline (T0) and after the 14-week period (T1).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina García Muñoz, PhD, PT; Phone Number: +34954551468; Email: ccriss.g@gmail.com
• Study Contact Backup: Name: Sahar TaghipourAzam, PT; Phone Number: +34654238544; Email: saharttpp@gmail.com; yogamigincidencias@gmail.com

Study Locations

• Spain
  • Sevilla
    • Seville, Sevilla, Spain, 41013
      • Recruiting
      • University Hospital Virgen del Rocio
      • Contact: Sahar TaghipourAzam, PT; Phone Number: +34654238544; Email: saharttpp@gmail.com
      • Contact: Cristina García Muñoz, PhD; Phone Number: +34954551468; Email: yogamigincidencias@gmail.com
      • Principal Investigator: Cristina García Muñoz, Physiotherapist, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Adults aged 18-65 years
• Diagnosis of episodic high-frequency migraine according to ICHD criteria
• Diagnosis confirmed by a neurologist
• At least 1-year history of migraine
• Receiving stable pharmacological treatment for ≥3 months before enrollment
• Willing to maintain stable medication during the study
• Ability to understand study procedures and complete assessments
• Signed informed consent
• Willingness to be randomized

Exclusion Criteria

• Other significant neurological disorders
• Severe psychiatric conditions affecting participation
• Medical contraindications to moderate physical activity
• Chronic migraine (≥15 headache days/month)
• Use of more than one preventive migraine medication
• Lack of Spanish language comprehension
• Lack of internet access or digital skills for online intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Experimental Group Label: Hatha Yoga + Usual Pharmacological Treatment Type: Experimental; Online Hatha Yoga Program (12 weeks + 2-week follow-up); 2 sessions per week; 30-45 minutes per session; Asynchronous video-based home practice; Standard pharmacological treatment maintained	Other: Hatha yoga; Online Hatha Yoga Program (12 weeks + 2-week follow-up); 2 sessions per week; 30-45 minutes per session; Asynchronous video-based home practice; Standard pharmacological treatment maintained
Active Comparator: Arm 2: Control Group Label: Usual Pharmacological Treatment Only Type: Active Comparator / Control; Continuation of usual pharmacological migraine treatment; No structured exercise/yoga program; Usual clinical follow-up; Post-study access to yoga program offered	Other: Control group (receiving standard medical therapy alone); Continuation of usual pharmacological migraine treatment; No structured exercise/yoga program; Usual clinical follow-up; Post-study access to yoga program offered; Other Names: CONTROL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine Frequency	Number of migraine days per month recorded via headache diary	Baseline and Week 14
Migraine Pain Intensity	Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged	Baseline and Week 14
Functional Impact of Migraine	HIT-6 and MIDAS questionnaire scores	Baseline and Week 14
Percentage of Completed Yoga Sessions	Adherence to the yoga program assessed as the percentage of prescribed Hatha Yoga sessions completed during the 12-week intervention period. Values range from 0% to 100%, with higher percentages indicating greater adherence to the intervention.	Weeks 1 through 12
Exercise Adherence Rating Scale Score	General adherence to the yoga program assessed using the Exercise Adherence Rating Scale (EARS). The EARS includes 6 items scored on a 0-4 Likert scale, with total scores ranging from 0 to 24. Higher scores indicate greater exercise adherence.	Week 14
PADEX Checklist Score	Program-related adherence facilitators assessed using the Promoting Adherence to Physical Exercise (PADEX) checklist. The PADEX checklist includes 23 dichotomous Yes/No items. The score will be expressed as the percentage of affirmative responses, ranging from 0% to 100%. Higher percentages indicate a greater presence of program features supporting adherence.	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Patient Impression of Change (PGIC)	Patient-perceived global change assessed using the Patient Global Impression of Change scale. The scale ranges from 1 to 7, where 1 indicates "very much improved" and 7 indicates "very much worse". Higher scores indicate worse perceived global change.	Week 14
Physical Activity Level	Physical activity assessed using the World Health Organization Global Physical Activity Questionnaire. The outcome will be reported as total metabolic equivalent task minutes per week. The minimum value is 0 MET-minutes/week, with no predefined maximum value. Higher values indicate greater physical activity.	Baseline and Week 14
Sleep Quality	Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating worse sleep quality.	Baseline and Week 14
Hospital Anxiety and Depression Scale Anxiety Subscale Score	Anxiety symptoms assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.	Baseline and Week 14
Hospital Anxiety and Depression Scale Depression Subscale Score	epression symptoms assessed using the depression subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.	Baseline and Week 14

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Principal Investigator: Cristina García Muñoz, PhD, University of Seville; Study Chair: María Dolores Cortés Vega, Physiotherapist, PhD, University of Seville

Publications and helpful links

General Publications

• [1] Kisan R, Sujan M, Adoor M, et al. Effect of Yoga on migraine: A comprehensive study using clinical profile and cardiac autonomic functions. Int J Yoga 2014;7:126-32. https://doi.org/10.4103/0973-6131.133891. [2] Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia 2018;38:1-211. https://doi.org/10.1177/0333102417738202. [3] Hawker GA, Mian S, Kendzerska T, et al. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res 2011;63. https://doi.org/10.1002/acr.20543. [4] Stewart WF, Lipton RB, Dowson AJ, et al. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology 2001;56. https://doi.org/10.1212/WNL.56.suppl_1.S20. [5] Kosinski M, Bayliss MS, Bjorner JB, et al. A six-item short-form survey for measuring headache impact: The HIT-6TM. Qual Life Res 2003;12:963-74. https://doi.org/10.1023/A:1026119331193. [6] Pérez-Huerta BD, Díaz-Pulido B, Godínez-Jaimes F, et al. Cultural adaptation and psychometric validation of the exercise adherence Rating scale Mexican Spanish version (EARS-Mx). Musculoskelet Sci Pract 2025;77:103308. https://doi.org/10.1016/j.msksp.2025.103308. [7] Newman-Beinart NA, Norton S, Dowling D, et al. The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS). Physiotherapy 2017;103:180-5. https://doi.org/10.1016/j.physio.2016.11.001. [8] Lavín-Pérez AM, Del Coso J, Luque-Casado A, et al. Development and validation of the Spanish version of the PADEX checklist to promote adherence

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; Migraine; headache; Exercise therapy; online intervention; Non-pharmacological intervention; complementary therapy; Hatha yoga
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Headache; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: HVR-MIC-YOGA-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No