Integrative and Complementary Therapy for Episodic Migraine and Tension-type Headache (NCT06764914) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Integrative and Complementary Therapy for Episodic Migraine and Tension-type Headache
130 participantsStarted 2025-01-01
Plain-language summary
This study is a monocentric uncontrolled observational study to evaluate a 12-14 day inpatient stay in an internal medicine clinic for integrative and complementary medicine for patients with episodic migraine and/or episodic tension headache. The aim is to investigate the extent to which a 14-day inpatient stay can influence a reduction in headache days and/or pain intensity, medication use, quality of life, anxiety, depression, perceived stress, general well-being, and a reduction in sick days/work absenteeism, and prevent the chronification of migraine and may counteract the chronification of migraine or tension-type headache. In addition, patients' previous experiences with complementary naturopathic therapies, expectations and perceived benefits in everyday life will be analysed.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Episodic migraine (\<15 headache days/month in the last 3 months)
* Episodic tension headache (\<15 headache days/month in the last 3 months)
* Mixed forms or parallel occurrence of both types of headache is permitted
* Diagnosis confirmed in advance by a neurologist
* Mandatory imaging to exclude another cause of headache before or during hospitalisation (cMRI or cCT)
* Participation in the integrative headache supply programm oft the health insurence provider Barmer Ersatzkasse and Techniker Krankenkasse
* Signed declaration of consent
Exclusion Criteria:
* Age younger than 18 years
* Chronic migraine (15 migraine days in the last 3 months) or chronic tension type headache
* Medication-induced headache/painkiller abuse (\> 10 triptans/combination analgesics/ergotamines/opiates or \>15 classical analgesics per month)
* Acute severe mental illness (e.g. severe depression with suicidal tendencies)
* Acute, severe physical illness that prevents participation in the inpatient naturopathic programme or emergency inpatient treatment of a different kind (e.g. ongoing treatment of a cancer severe acute illness of the cardiovascular system such as heart attack, stroke, acute insufficiency of other organs (kidney, liver, etc.), other severe acute neurological diseases, e.g. relapse of multiple sclerosis, uncontrolled epilepsy)
* Pregnancy/lactation period
* Simultaneous participation in other clinical studies
* No consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of headache days/month (headache diary);
Timeframe: 48 weeks after inpatient hospitalisation