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.
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.
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
Parallel
Intervention yoga based exercises
Other intervention8-12 weeks intervention using digital och face to face yogic exercises
Headache diary - frequency of headaches
Headache frequency (number of days a month and number of attacks per day)
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.
Actrigraph - sleep quality and activity level
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.
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). People with insomnia have higher DBAS scores than good sleepers. Administration time 10 minutes
Perceived stress Questionnaire (PSQ-30)
PSQ includes 30 questions and measures stress symptoms in adults. It includes a Likertscale with 4 options. Where 1= almost never; 2= sometimes;3=oftan;4=most of the time Scoring Total score = summary of all items Reversed scoring for questions: 1, 7, 10, 13, 17, 21, 25, 29 PSQ Index (totalscore-30)/90 https://onlinelibrary.wiley.com/doi/abs/10.1002/smi.946
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