Clinical trial NCT03503734: Integrated Care for Migraine and Chronic Tension-type Headaches
Official title: Integrated Care for Migraine and Chronic Tension-type Headaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Headache
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients insured with Barmer GEK or Techniker Krankenkasse, large German statutory health insurances, and diagnosed with migraine and/or tension-type headaches were eligible for integrated care. All patients, who were over 18 years old with headache at least five days per month for at least 6 months and current intake of a) at least 10 triptans per month or b) analgesic drugs that can themselves elicit headache were suited to be involved in the observational study. Patients were referred by specialists or general practitioners to the Department of Internal and Integrative Medicine.

Brief summary: Chronic headache is among the most common neurological disorders with major physical, psychological, social and economic impact. The aim of this prospective observational study isto investigate the effects of an interdisciplinary multimodal integrated care program in patients with chronic migraine and/or tension-type headache.

158 patients with chronic migraine or tensions-type headache at least five days per month for at least 6 months and current intake of triptans (migraine) or analgesic drugs (tension-type headache) are eligible. Patients undergo inpatient, outpatient and/or semi-stationary treatment including conventional headache diagnostics and therapy as well as traditional Chinese medicine, European naturopathy, and mind-body-medicine approaches. Headache frequency is defined as the primary outcome; secondary outcomes include pain (visual analog scale, Pain Perception Scale), triptans and analgesics use (headache diary), health-related quality of life (SF-36), function (Headache Disability Inventory, Patient-specific Functional Scale), depression and anxiety (Hospital Anxiety and Depression Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Outcomes are assessed at treatment start, treatment end and 6 months after treatment end.

Detailed description: Chronic headache is among the most common neurological disorders with major physical, psychological, social and economic impact. The aim of this prospective observational study isto investigate the effects of an interdisciplinary multimodal integrated care program in patients with chronic migraine and/or tension-type headache.

158 patients with chronic migraine or tensions-type headache at least five days per month for at least 6 months and current intake of triptans (migraine) or analgesic drugs (tension-type headache) are eligible. Patients undergo inpatient, outpatient and/or semi-stationary treatment including conventional headache diagnostics and therapy as well as traditional Chinese medicine, European naturopathy, and mind-body-medicine approaches. Headache frequency is defined as the primary outcome; secondary outcomes include pain (visual analog scale, Pain Perception Scale), triptans and analgesics use (headache diary), health-related quality of life (SF-36), function (Headache Disability Inventory, Patient-specific Functional Scale), depression and anxiety (Hospital Anxiety and Depression Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Outcomes are assessed at treatment start, treatment end and 6 months after treatment end.

Eligibility criteria: Inclusion Criteria:

headache at least five days per month for at least 6 months current intake of a) at least 10 triptans per month or b) analgesic drugs that can themselves elicit headache

Exclusion Criteria: None.

Primary outcomes:
measure: Headache frequency
timeFrame: Treatment end, an average of 5 months
Secondary outcomes:
measure: Headache frequency
timeFrame: 6 months after treatment end
measure: Pain intensity
timeFrame: Treatment end, an average of 5 months
measure: Pain intensity
timeFrame: 6 months after treatment end
measure: Pain bothersomeness
timeFrame: Treatment end, an average of 5 months
measure: Pain bothersomeness
timeFrame: 6 months after treatment end
measure: Pain perception
timeFrame: Treatment end, an average of 5 months
measure: Pain perception
timeFrame: 6 months after treatment end
measure: Quality of life
timeFrame: Treatment end, an average of 5 months
measure: Quality of life
timeFrame: 6 months after treatment end
measure: Headache Disability
timeFrame: Treatment end, an average of 5 months
measure: Headache Disability
timeFrame: 6 months after treatment end
measure: Anxiety/Depression Scale
timeFrame: Treatment end, an average of 5 months
measure: Anxiety/Depression Scale
timeFrame: 6 months after treatment end
measure: Function
timeFrame: Treatment end, an average of 5 months
measure: Function
timeFrame: 6 months after treatment end
measure: Self-Efficacy
timeFrame: Treatment end, an average of 5 months
measure: Self-Efficacy
timeFrame: 6 months after treatment end
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
state: NRW
Study officials:
References: