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

Condition(s) studied

Investigational drug(s) / intervention(s)

Intervention yogabased movements: Yogabased movements weekly (online) or face to face for primary headaches"

Study 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:

1. Headache symptoms and frequency
2. Sleep quality
3. Overall life quality

\*\*Purpose and Goals:\*\* This pilot study aims to evaluate the feasibiiity of a web-based yoga or live face to face (FTF) intervention in individuals suffering from severe primary headaches-mainly chronic migraine and/or cluster headache. The study will assess the effect of YB on health-related quality of life, with a focus on sleep quality and mental health as depression and anxiety. A secondary objective is to analyze changes in headache frequency, intensity, and duration associated with primary headache conditions. The pilot study will follow later on with a RCT study (will be registered later). The RCT study will have a comparison group to conventional treatment.

\*\*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.

Eligibility

Primary outcome measure(s)

• Headache diary - frequency, intensity and duration — Baseline and after the 8-12 weeks after the intervention and follow-up after 3 and 6 months
  Headache frequency (number of days a month and number of attacks per day), headache intensity/pain using a VAS-scale, head ache duration (number of hours/minutes during an attack).

Trial sites (1)

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