Integrative and Complementary Therapy for Episodic Migraine and Tension-type Headache
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKliniken Essen-Mitte
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Patients with episodic headaches (TTH and/or migraine) who choose to spend 12 to 14 days at the Clinic for Integrative and Complementary Medicine. The diagnosis must be confirmed by a neurological examination.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
integrative and complementary medicine
Other interventionTreatment 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. After inpatient treatment, patients can receive up to 10 additional outpatient treatments at our TCM outpatient clinic. There is also a 10-week programme for day patients. This focuses on ordinal therapy to achieve sustainable, balanced lifestyle changes. This includes classic acupuncture and drainage techniques such as Gua Sha (connective tissue massage in TCM) or cupping, as well as neural therapy, electro-acupuncture and others. Daily medical visits and self-care advice are also included.
Treatment groups
130 Participants
are divided into 1 treatment groupGroup A: episodic migraine and/or episodic tension headache (tension-type headache TTH)1 intervention
Trial outcomes
Primary outcomes
1
Number of headache days/month (headache diary);
Time frame
48 weeks after inpatient hospitalisationSecondary outcomes
1
Pain Perception Scale (PPS) using a visual analogue scale (VAS)
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.
Time frame
48 weeks after inpatient hospitalisation2
Number of sick days from T0 to T3 (headache diary)
Time frame
48 weeks after inpatient hospitalisation3
- Number of painkillers/month (headache diary)
Time frame
48 weeks after inpatient hospitalisation4
Headache Disability Index (HDI)
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.
Time frame
48 weeks after inpatient hospitalisationOther outcomes
1
- Causation and Intensity of Adverse events (AEs)
negative side effects
Time frame
12 months after inpatient hospitalisation2
Medical service use figures
Previous experience, use and expectations of integrative and complementary therapies will also be assessed using socio-demographic data.
Time frame
48 weeks after inpatient hospitalisation3
Work ability
Work ability is recorded as part of the socio-demographic data and can be rated on a scale from '0' (total inability to work) to '10' (best possible ability to work).
Time frame
48 weeks after inpatient hospitalisationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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