Yogabased Movements for Primary Headaches (Migraine and/or Cluster Headache) - YOURHEAD

Yogabased Movements Weekly (Online Live or Face to Face) for Primary Headaches

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

• Purpose and Goals:** This randomized controlled study aims to evaluate the effect of a web-based yoga (YB) or live face to face (FTF) intervention in individuals suffering of primary headaches-mainly chronic migraine and/or cluster headache. The study will assess the effect of YB on health-related changes in headache frequency, intensity, and duration associated with primary headache conditions, with a focus headache frequency. A secondary objective is to analyze quality of life, sleep quality, mental health as depression and anxiety. The RCT will also measure objective sleep and biomarkers. We are now summarizing the effects after a pilot study.
• Relevance for the Patient Group:** The core objective of the project is to determine whether yoga-based exercises can serve as a complementary treatment to enhance quality of life and health in patients with severe primary headache. To ensure equal healthcare access, this intervention will be delivered in digital format and/or FTF to optimize availability and expand care for individuals with primary headache disorders. These efforts aim to improve life quality and well-being in a vulnerable patient population. Headache conditions often affect individuals in their most productive years, and many live with symptoms for decades. Both work and private life are frequently disrupted, resulting in sick leave and social isolation. Close relatives are also affected, as those suffering from headaches require more recovery time to cope with daily life. With this proposed project, we aim to use physical yoga, rooted in holistic traditional medicine, to help individuals with severe primary headache achieve better physical and mental health-particularly improved sleep quality, which in turn enhances 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.

Inclusion Criteria:

• Diagnosed chronic migraine and/or cluster (Hortons) headache
• Men and women 18-65 years
• Diagnosed with chronic/high frequency migraine (≥15 headache days/month with at least ≥8 with migraine)
• Diagnosed with chronic cluster head ache (i.e shorter remission than 3 months per year), diagnosed according to ICHD-III criteria.
• Ability to perform yoga based moments and to give consent.
• Internet connection with computer/ipad/mobile to perform digitally/tele-health instructions
• Willing to use wristwatch for actigraphy
• Willing to leave blood samples in laboratory

Exclusion Criteria:

• Recent or planned operations during the last 6 weeks
• Drug dependence, alcohol dependence, mental disorders as psychosis, bipolar disorder, anxiety as PTSD etc)
• Parallel enrollment in other clinical trails
• Unmedicated high blood pressure, heart disease as heart failure
• Non Swedish speaking
• Not able to perform low intensity exercise at home or FTF (face to face) - both online or live.
• Participants unsure to participate due to drug addiction or other causes
• Disorientation and not able to inform regarding other serious conditions