MigraineMIGRANE-YOGANCT07694063
Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine
A study testing Hatha yoga in people with Migraine, run by University of Seville at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Hatha yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jan 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Ability to understand study procedures and complete assessments
- Signed informed consent
- Willingness to be randomized
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University Hospital Virgen del Rocio
Seville, Sevilla, 41013
Sahar TaghipourAzam, PT, +34654238544, saharttpp@gmail.com
Cristina García Muñoz, PhD, +34954551468, yogamigincidencias@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Migraine
- Being tested
- Control group (receiving standard medical therapy alone), Hatha yoga
- Keywords
- Migraine, Hatha yoga, Exercise therapy, Non-pharmacological intervention, randomized controlled trial, online intervention, headache, complementary therapy
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group (receiving standard medical therapy alone)Other
Also called CONTROL
- Continuation of usual pharmacological migraine treatment
- No structured exercise/yoga program
- Usual clinical follow-up
- Post-study access to yoga program offered
Hatha yogaOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Experimental Group Label: Hatha Yoga + Usual Pharmacological Treatment Type: Experimental | 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 Receives: Other: Hatha yoga |
| Arm 2: Control Group Label: Usual Pharmacological Treatment Only Type: Active Comparator / Control | Active comparator | * Continuation of usual pharmacological migraine treatment
* No structured exercise/yoga program
* Usual clinical follow-up
* Post-study access to yoga program offered Receives: Other: Control group (receiving standard medical therapy alone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Frequency
Number of migraine days per month recorded via headache diary
Measured: Baseline and Week 14
Migraine Pain Intensity
Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged
Measured: Baseline and Week 14
Functional Impact of Migraine
HIT-6 and MIDAS questionnaire scores
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 14
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start27 Jan 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina García Muñoz, University of Seville
- Investigators
- Cristina García Muñoz, PhD, Principal investigator, University of SevilleMaría Dolores Cortés Vega, Physiotherapist, PhD, Study chair, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694063
- Sponsor's protocol ID
- HVR-MIC-YOGA-2025
- Acronym
- MIGRANE-YOGA
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine
- ClinicalTrials.gov ID
- NCT07694063
- Acronym / sponsor ID
- MIGRANE-YOGA / HVR-MIC-YOGA-2025
- Conditions
- Migraine
- Keywords
- Migraine, Hatha yoga, Exercise therapy, Non-pharmacological intervention, randomized controlled trial, online intervention, headache, complementary therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Experimental Group Label: Hatha Yoga + Usual Pharmacological Treatment Type: Experimental | Experimental | 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 |
| Arm 2: Control Group Label: Usual Pharmacological Treatment Only Type: Active Comparator / Control | Active comparator | 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group (receiving standard medical therapy alone)Also: CONTROL* Continuation of usual pharmacological migraine treatment * No structured exercise/yoga program * Usual clinical follow-up * Post-study access to yoga program offered | Other | Arm 2: Control Group Label: Usual Pharmacological Treatment Only Type: Active Comparator / Control |
| 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 | Other | Arm 1: Experimental Group Label: Hatha Yoga + Usual Pharmacological Treatment Type: Experimental |
Primary outcome
Migraine Frequency
Time frame: Baseline and Week 14
Number of migraine days per month recorded via headache diary
Migraine Pain Intensity
Time frame: Baseline and Week 14
Visual Analogue Scale (VAS/EVA 0-10), daily recorded and averaged
Functional Impact of Migraine
Time frame: Baseline and Week 14
HIT-6 and MIDAS questionnaire scores
Percentage of Completed Yoga Sessions
Time frame: Weeks 1 through 12
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.
Exercise Adherence Rating Scale Score
Time frame: Week 14
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.
PADEX Checklist Score
Time frame: Week 14
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.
5 secondary outcomes
Global Patient Impression of Change (PGIC)
Time frame: Week 14
Physical Activity Level
Time frame: Baseline and Week 14
Sleep Quality
Time frame: Baseline and Week 14
Hospital Anxiety and Depression Scale Anxiety Subscale Score
Time frame: Baseline and Week 14
Hospital Anxiety and Depression Scale Depression Subscale Score
Time frame: Baseline and Week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background[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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina García Muñoz, PhD principal investigator
University of Seville
María Dolores Cortés Vega, Physiotherapist, PhD study chair
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha yoga in people with Migraine, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina García Muñoz, PhD, PT (+34954551468, ccriss.g@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine Frequency (time frame: Baseline and Week 14). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07694063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.