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Brief Summary:
Migraine and/or Cluster Headache: Study Overview
**Background:** Migraine and cluster headache are two primary headache disorders that significantly impact quality of life and functionality in those affected. According to the WHO's recurring burden of disease reports, migraine is among the neurological conditions responsible for the highest number of years lost due to illness. The headaches associated with migraine and cluster headache range from moderate to severe and cause great suffering. Available treatments do not work for everyone and are often associated with adverse side effects. Physical activity has been shown in several studies to have a positive effect on headache. Given the high prevalence of mental health issues, stress, and sleep problems within this patient group, relaxation and low-intensity exercise such as yoga-based movements (YB) could potentially help individuals improve sleep and well-being, while also providing some preventive effect on headaches.
**Hypothesis:**
Individuals with severe migraine or cluster headache have a strong need for new treatment options. Alternative therapies such as yoga-based exercises, when combined with standard medical treatment as per clinical guidelines, may positively impact:
Headache symptoms, Sleep quality and Overall life quality
Detailed Description:
Current Situation
Migraine and cluster headache are two neurological conditions characterized by recurrent attacks of severe headache. Approximately 14% of the population is estimated to suffer from migraines, while cluster headaches have a prevalence of around 0.1%. The phenotype is marked by unilateral headache attacks lasting approximately 15 minutes to three hours for cluster headache and three hours to three days for migraine. Acute treatment for migraines and cluster headaches typically involves triptans or oxygen therapy to break the attacks, and prophylactic treatment when needed.
Studies have shown that individuals with headaches experience significant impacts on quality of life and often suffer from mental health issues. Research from Karolinska Institutet and the Headache Centre in Copenhagen has demonstrated sleep disturbances among individuals with cluster headaches. Sleep-related diagnoses are also frequently reported in individuals with migraine, and migraine is more prevalent among shift workers compared to non-shift workers. Collectively, these studies indicate a strong connection between sleep problems, mental health, and headache.
The disease burden in high-frequency migraine, chronic migraine, and cluster headache is substantial, and additional alternative treatments are needed alongside standard pharmaceutical therapies. Individuals with these headache types report higher sick leave rates than the general population, and cluster headache sufferers with concurrent mental health issues show increased prevalence for long-term sick leave and disability pension.
Role of Yoga-Based Exercises (YB)
Yoga-based exercises have gained attention in healthcare and are used as complementary treatments for various conditions. Reviews and meta-analyses show effects on stress symptoms, mental states such as sleep disturbances and depression. Web-based yoga interventions have also improved sleep and stress, as well as chronic neck and back pain. Improvements have been observed in endothelial function and inflammation markers.
A review article from China indicates that physical yoga (similar to the planned intervention) appears to reduce headache intensity, duration, and frequency. Previous studies show reductions in migraine headache following yoga interventions, and smaller Indian studies report effects on headache intensity and quality of life in migraine. Research in Western contexts is limited and studies conducted in India tend to show more positive results-possibly due to higher treatment dosages or contextual influences, including placebo or Hawthorne effects.
The American Migraine Foundation recommends yoga-based exercises as a complementary treatment for stress reduction and migraine symptom management, as stress is a common migraine trigger. There is currently no research on yoga-based interventions for cluster headaches, and only a few published studies on migraines.
Traditional Medical Practices
Indian traditional medicine recommends specific exercises (e.g., inversions) for treating headaches, high blood pressure, and improving sleep quality and insomnia. Inversions appear to activate deep brain regions related to sleep and have a calming effect. Sleep disorders often trigger migraines and vice versa. Melatonin rhythms, which may be unstable in headache conditions, often stabilize following yoga-based interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention yogic exercises | Experimental | Yogabased movements (online live or face to face) for primary headaches |
|
| No intervention - waiting list | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention yoga based exercises | Other | 8-12 weeks intervention using digital och face to face yogic exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache diary - frequency of headaches | Headache frequency (number of days a month and number of attacks per day) | Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Actrigraph - sleep quality | Objective measurement of sleep using actigraphs worn on the wrist for one week at baseline and one week at the end of the study. ActTrust 2, Actiwatch or another brand is a wristwatch-like device that measures acceleration. By measuring acceleration at the wrist, an estimate of physical activity can be obtained, from which an activity pattern for a participant can be produced. This provides an objective measure of sleep duration and sleep quality. The sleep watch measures activity in general using tri-axial raw data accelerometer along with environmental light and temperature sensors and sleep is part of this through looking at reduced activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marian E Papp, PhD | Contact | +46706946553 | marian.papp@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Recruiting | Huddinge | 141 83 | Sweden |
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| Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| Dysfunctional Beliefs and attitudes about sleep (DBAS-10) | Measures sleep related cognitions in a VAS (visual analog)-scale. The scale identifies specific, irrationell and affective thoughts that can disturb insomnia and evaluated sleep related cognitions. Factor I (5 items) was labeled Beliefs about the Immediate Negative Consequences of Insomnia. Factor II (3 items) was labeled Beliefs about the Long-term Negative Consequences on Insomnia. Factor III was labeled Beliefs about the Need for Control Over Insomnia (2 items). Administration time 10 minutes | Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| Quality of life - headache intensity scale (HIT-6) | Total score between 36-78, low scores indicates high quality of life | Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| Hospital Anxiety and Depression Scale (HADS) | Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire designed to assess anxiety and depression levels in individuals, particularly in non-psychiatric hospital settings. Structure: The questionnaire consists of 14 items, divided into two subscales: HADS-A for anxiety and HADS-D for depression. HADS uses a 4-point Likert scale (0 = not at all, 3 = most of the time), with separate scores for anxiety and depression subscales (0-21 each). Total scores range from 0 to 42, with higher scores indicating greater symptom severity. Cut-off scores for interpretation include: 0-7: Normal. 8-10: Mild. 11-21: Moderate to severe. | Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| Sleep quality using insomnia severity scale (ISI) | Primary Outcome Measure: Sleep quality using insomnia severity scale (ISI) [Time Frame: Baseline and 8-12 weeks after the end of the intervention, follow-up up to 24 weeks] Total score from 0-28 - a score of 0-7 no clinical insomnia, 8-14 no insomnia, 15-21 clinical insomnia moderate, 22-28 clinical insomnia severe | Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| Perceived stress scale (PSS-10) | The interpretation of perceived stress scale (PSS-10) scores is not diagnostic but provides a general sense of of perceived stress. Generally, a score between 0-13 is considered low stress, 14-26 is moderate stress, and 27-40 is high stress. | Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| Generalized Anxiety Disorder scale (GAD-7) | The generalized anxiety disorder scale (GAD-7) score helps assess the severity of anxiety symptoms, with scores ranging from 0 to 21 indicating varying levels of anxiety severity. 0 - 4: No to Minimal Symptoms - Indicates little to no anxiety symptoms. 5 - 9: Mild Symptoms - Suggests mild anxiety that may not significantly impact daily functioning. 10 - 14: Moderate Symptoms - Indicates moderate anxiety, which may affect daily activities and quality of life. 15 - 21: Severe Symptoms - Reflects severe anxiety that likely requires clinical intervention and support. Clinical Relevance A score of 10 or higher may indicate a preliminary diagnosis of Generalized Anxiety Disorder (GAD). | Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| Nijmegen Dysfunctional breathing scale | The Nijmegen Questionnaire (often called the Nijmegen Dysfunctional Breathing Scale) is a validated screening tool designed to identify symptoms of dysfunctional breathing, particularly hyperventilation/overbreathing syndrome. It consists of 16 symptom items scored on a 0-4 scale, with higher scores indicating greater respiratory distress. A total score above 19-23 suggests clinically relevant breathing dysfunction. 16 items covering common symptoms such as chest pain, dizziness, blurred vision, shortness of breath, and feelings of tension. Each item is rated on a 5-point Likert scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Very often. 19 points: Indicates possible dysfunctional breathing or hyperventilation. 23 points: Stronger indication of hyperventilation syndrome | Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| Headache diary - intensity of headaches | Headache intensity/pain using a visual analog scale (VAS-scale) where 0 is no pain and 100 is maximal pain. | Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| Headache diary - duration of headaches | Headache duration (number of hours/minutes during an attack). | Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks |
| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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