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

NCT06764914 | Not Yet Recruiting

• 1 other identifier: 2023273
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine; Headache, Tension-Type

Keywords

Migraine; Headache, Tension-Type

Outcome Measures

Primary Outcomes (1)

• Number of headache days/month (headache diary);

  48 weeks after inpatient hospitalisation

Secondary Outcomes (8)

• Pain Perception Scale (PPS) using a visual analogue scale (VAS)

  48 weeks after inpatient hospitalisation

• 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

• Short-Form Health Survey (SF-12)

  48 weeks after inpatient hospitalisation

Other Outcomes (3)

• - Causation and Intensity of Adverse events (AEs)

  12 months after inpatient hospitalisation

• Medical service use figures

  48 weeks after inpatient hospitalisation

• Work ability

  48 weeks after inpatient hospitalisation

Study Arms (1)

episodic migraine and/or episodic tension headache (tension-type headache TTH)

Other: integrative and complementary medicine

Interventions

integrative and complementary medicine OTHER

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. 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.

episodic migraine and/or episodic tension headache (tension-type headache TTH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead

MeSH Terms

Conditions

Migraine Disorders; Tension-Type Headache

Interventions

Complementary Therapies

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Petra Voiß, PD Dr. med.

  Evang. Kliniken Essen-Mitte, Clinic for Integrative Oncology & Supportivemedicine

  STUDY CHAIR

Central Study Contacts

Wiebke Kohl-Heckl, Dr. med.

CONTACT

25058; W.Kohl-Heckl@kem-med.com

Verena Boventer

CONTACT

39061; V.Boventer@kem-med.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 9, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: January 9, 2025

Record last verified: 2025-01