Integrative and Complementary Therapy for Episodic Migraine and Tension-type Headache

Not yet recruiting

• Conditions: Migraine; Headache, Tension-Type

• Registration Number: NCT06764914
• Lead Sponsor: Kliniken Essen-Mitte

Brief 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.

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.

Study Timeline

• Study First Submitted: 2024-12-12
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Primary Completion: 2030-01-01
• Study Completion: 2031-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of headache days/month (headache diary);	48 weeks after inpatient hospitalisation

Secondary Outcome Measures

Name	Time	Method
Pain Perception Scale (PPS) using a visual analogue scale (VAS)	48 weeks after inpatient hospitalisation	The Pain Perception Scale is a tool to measure the patient's subjective assessment of symptoms, using the visual analogue scale of pain intensity to record pain on a scale from '0' to '10'. '0' is no pain and '10' is the highest level of pain.
Number of sick days from T0 to T3 (headache diary)	48 weeks after inpatient hospitalisation
- Number of painkillers/month (headache diary)	48 weeks after inpatient hospitalisation
Headache Disability Index (HDI)	48 weeks after inpatient hospitalisation	HDI measure the impact of headache disorders on quality of life. The HDI is a 27-item questionnaire. The first two questions relate to frequency (once per month; more than once per month but less than four per month; more than once per week) and intensity ('mild', 'moderate' and 'severe').; The remaining 25 questions are designed to assess the quality of life affected by headache. Each question can be scored from 0 to 4 points. A total score of '10-28' indicates mild disability, '30-48' is moderate, '50-68' is severe and '72' or more is complete disability.
Short-Form Health Survey (SF-12)	48 weeks after inpatient hospitalisation	The Short-Form Health Survey 12 assesses the impact of health on an individual's daily life. The SF-12 theoretically ranges from '0' (lowest possible quality of life) to '100' (highest possible quality of life). The SF-12 measures disease-related quality of life using 12 items divided into 8 subscales. Higher scores indicate better quality of life.
Hospital Anxiety and Depression Scale (HADS)	48 weeks after inpatient hospitalisation	Anxiety and depression are measured using the HADS. The questionnaire contains 14 items, 7 on the anxiety scale and 7 on the depression scale. Total scores on the HADS-A (anxiety) and HADS-D (depression) scales range from '0-21', with higher scores indicating higher levels of anxiety/depression. Scores of '0-7' per HADS subscale (HADS-A/D) are considered 'normal', '8-10' as 'mild', scores above '11' as severe (up to '14' 'moderate', '15-21' 'severe').
Flourishing Scale (FS)	48 weeks after inpatient hospitalisation	Subjective well-being is assessed using the Flourishing Scale. This consists of 8 socio-psychological well-being items that can be scored on a scale from '1' to '7'. The possible range of the total score is from '8' (lowest possible score) to '56' (highest possible score). A high score corresponds to a person with many psychological resources and strengths.
Perception Stress Scale (PSS-10)	48 weeks after inpatient hospitalisation	Perceived stress is measured using two scales (helplessness and self-efficacy) based on 10 items. The scales can be scored from '0' (never) to '5' (very often). The total score is calculated as the sum of the helplessness scale items and the sum of the inverted self-efficacy scale items. Higher scores indicate higher levels of stress.