Integrative and Complementary Therapy for Episodic Migraine and Tension-type Headache
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: integrative and complementary medicine.
- Who it may be relevant to
- Registry conditions: Migraine, Headache, Tension-Type. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
NAturheilkundliche Komplextherapie Bei Episodischer MIgräne Und KOpfschmerz Vom Spannungstyp
Overview
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.
Detailed description
Primary headache disorders are among the most common neurological disorders worldwide, with a lifetime prevalence of over 90%. Tension-type headache (TTH) is the most common type of primary headache. It manifests as a dull, pressing, tightening pain that usually 'rises' from the neck to the back of the head and down to the temples on both sides, but can theoretically occur in any part of the head. The frequency of pain attacks is used to define episodic (\< 15 days/month or \< 180 days/year) and chronic TTH (\> 15 days/month for \> 3 months or \> 180 days/year). The main therapeutic options are classical analgesics (non-steroidal anti-inflammatory drugs, NSAIDs; Novalgin) in acute cases or tricyclic antidepressants as prevention. Prophylaxis can be combined with (endurance) exercise or acupuncture. Migraine is rarer than TTH, affecting about 9% of the population, but it is one of the most common causes of disability worldwide. It is defined as a headache with or without preceding neurological symptoms (called an aura) and occurs mainly in middle age, between 20 and 50 years. In acute attacks, migraine headaches are treated with medication (usually classic analgesics such as NSAIDs, Novalgin or migraine-specific triptans). In cases of severe distress due to frequent and severe attacks, medication may also be used as a prophylactic measure. A distinction is also made between episodic migraine (\< 15 days in the last 3 months) and chronic migraine (\> 15 days/month in the last 3 months). In addition to drug therapy there are also non-drug approaches such as acupuncture, behavioural therapy, biofeedback or relaxation techniques, which may be combined with drug prophylaxis. Complications of migraine include status migraenosus (migraine attacks lasting more than 72 hours), migraine stroke and/or chronicisation of migraine. The headache disorders listed above can occur alone or in combination. When they occur together, they can severely restrict a person's daily life. According to the German Society of Neurology (DGN-Deutsche Gesellschaft für Neurologie), multimodal approaches, such as inpatient multimodal pain therapy, are explicitly recommended only in the context of chronic headache, especially chronic migraine. In addition, there are often life-limiting comorbidities, which often worsen with chronicity. The Clinic for Integrative and Complementary Medicine at the Evangelische Kliniken Essen-Mitte has been treating patients with various pain disorders for more than 20 years. Within the framework of so-called integrative care concepts with the Techniker Krankenkasse (TK) and the Barmer Ersatzkasse (BEK), headache patients are treated with naturopathic-integrative methods both as inpatients and as outpatients. The aim of this prospective observational study is to evaluate the integrative-complementary concept in patients with episodic headache (migraine and/or tension headache) without medication abuse or medication-induced headache. It will be observed whether this concept can reduce sick days/work absences, pain intensity and frequency, and medication use, thus preventing chronicity.
Interventions
- Other integrative and complementary medicine
Treatment with integrative and complementary methods for both, inpatients and outpatients, includes conventional therapy, integrative methods and ordinal therapy/MBM, which are individually designed for each patient. Similar to a shedule, with therapy units from the following areas: hydrotherapy/thermotherapy, exercise therapy, physiotherapy, nutritional therapy and bodywork therapy, supplemented as required by phytotherapeutic and other therapies, such as acupuncture, neural therapy and cupping
Primary outcome measures
- Number of headache days/month (headache diary); [Time frame: 48 weeks after inpatient hospitalisation]
Secondary outcome measures (8)
- Pain Perception Scale (PPS) using a visual analogue scale (VAS) [Time frame: 48 weeks after inpatient hospitalisation]
- Number of sick days from T0 to T3 (headache diary) [Time frame: 48 weeks after inpatient hospitalisation]
- - Number of painkillers/month (headache diary) [Time frame: 48 weeks after inpatient hospitalisation]
- Headache Disability Index (HDI) [Time frame: 48 weeks after inpatient hospitalisation]
- Short-Form Health Survey (SF-12) [Time frame: 48 weeks after inpatient hospitalisation]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: 48 weeks after inpatient hospitalisation]
- Flourishing Scale (FS) [Time frame: 48 weeks after inpatient hospitalisation]
- Perception Stress Scale (PSS-10) [Time frame: 48 weeks after inpatient hospitalisation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06764914 · 2023273