Yogabaserade övningar Som Kompletterande Behandling Vid migrän Och/Eller klusterhuvudvärk YOURHEAD - a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Headache diary - frequency, intensity and duration
Study Overview
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 and frequency
- Sleep quality
- 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.
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Intervention
Yogabased movements weekly (online live or face to face) for primary headaches
Intervention: Intervention yogabased movements (Other)
Outcomes
Primary Outcomes
Headache diary - frequency, intensity and duration
Time Frame: 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).
Sleep quality using insomnia severity scale (ISI)
Time Frame: Baseline and 8-12 weeks after the intervention, follow up after 3 and 6 months
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
Quality of life - headache intensity scale (HIT-6)
Time Frame: Baseline and 8-12 weeks after the intervention and follow-up after 3 and 6 months
Total score between 36-78, low scores indicates high quality of life
Karolinska Sleep questionnarie (KSQ) - subjective sleepiness
Time Frame: Baseline and 8-12 after the intervention as well as follow-up 3 months and 6 months
KSQ includes 18 questions - on a 6 graded likert scale between 0-5, where 0 = never and 5 = always. Higher scores means more sleep problems. Each domain is calculated with a mean, sleep quality 4 questions, problem waking 3 questions, sleep apnea (breath pause - andningsuppehåll) - 3 questions, sleepiness/tiredness - 6 questions. One is not using total scores for the KSQ. It is also possible to calculate index-value for insomnia and sleep apnea. There are cut-off values to compare with a healthy population or other studies with the same disorder. There are cut-offs for KSQ for normal swedish population but also using the 90:e percentile for a swedish population (different for men and women)
Dysfunctional Beliefs and attitudes about sleep (DBAS-10)
Time Frame: Baseline and after 8-12 weeks of intervention and follow-up after 3 and 6 months
Measures sleep related cognitions in a VAS-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
Secondary Outcomes
- Quality of life - headache intensity scale (HIT-6)(Baseline and 8-12 weeks after the intervention and follow-up after 3 and 6 months)
- Dysfunctional Beliefs and attitudes about sleep (DBAS-10)(Baseline and after 8-12 weeks of intervention and follow-up after 3 and 6 months)
- Karolinska Sleep questionnarie (KSQ) - subjective sleepiness(Baseline and 8-12 after the intervention as well as follow-up 3 months and 6 months)
- Sleep quality using insomnia severity scale (ISI)(Baseline and 8-12 weeks after the intervention, follow up after 3 and 6 months)
- Migraine Disability Assessment Test (MIDAS)(Baseline and after 8-12 weeks after the intervention and 3 and 6 months follow-up)
- Nijmegen Dysfunctional breathing scale(Baseline and after 8-12 weeks after the intervention and 3 and 6 months follow-up)
- Hospital Anxiety and Depression Scale (HADS)(Baseline and after intervention of 8-12 weeks and follow-up after 3 and 6 months)
- Perceived stress scale (PSS-10)(Baseline and after 8-12 week intervention, follow-up after 3 and 6 months)
- Generalized Anxiety Disorder scale (GAD-7)(Baseline and 8-12 after the intervention as well as follow-up 3 months and 6 months)
- Headache diary - frequency, intensity and duration(Baseline and after the 8-12 weeks after the intervention and follow-up after 3 and 6 months)
Investigators
Marian Papp
Principal investigator, PhD
Karolinska Institutet