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NCT Number: NCT03503734

Integrated Care for Migraine and Chronic Tension-type Headaches

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.

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Key information

Conditions

Chronic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Essen, North Rhine-Westphalia, 45276, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrated headache care

Behavioral

The treatment can be realized on an inpatient, outpatient and/or day care basis, according to the severity level of illness and comorbidities.

The inpatient treatment takes place at the Department of Internal and Integrative Medicine. The stay is slated for 14 days.

Day care can follow the inpatient stay or can be applied as sole therapy. As part of the standard care provided at the Department for Internal and Integrative Medicine, it occurs at a semi-residential clinic for 6 hours once a week over a total of 10 weeks.

The outpatient treatment is delivered in the Department's outpatient ward. It consists of acupuncture, cupping, hydrotherapy and massages as well as nutritional counseling. The patients can additionally be offered one-to-one mind-body-medicine interventions.

Primary outcomes

  1. Headache frequency

    Time frame: Treatment end, an average of 5 months

    Headache days/month

Secondary outcomes

  1. Headache frequency

    Time frame: 6 months after treatment end

    Headache days/month

  2. Pain intensity

    Time frame: Treatment end, an average of 5 months

    100mm visual analog scale

  3. Pain intensity

    Time frame: 6 months after treatment end

    100mm visual analog scale

  4. Pain bothersomeness

    Time frame: Treatment end, an average of 5 months

    100mm visual analog scale

  5. Pain bothersomeness

    Time frame: 6 months after treatment end

    100mm visual analog scale

  6. Pain perception

    Time frame: Treatment end, an average of 5 months

    Pain Perception Scale

  7. Pain perception

    Time frame: 6 months after treatment end

    Pain Perception Scale

  8. Quality of life

    Time frame: Treatment end, an average of 5 months

    SF-12

  9. Quality of life

    Time frame: 6 months after treatment end

    SF-12

  10. Headache Disability

    Time frame: Treatment end, an average of 5 months

    Headache Disability Inventory (HDI)

  11. Headache Disability

    Time frame: 6 months after treatment end

    Headache Disability Inventory (HDI)

  12. Anxiety/Depression Scale

    Time frame: Treatment end, an average of 5 months

    Hospital Anxiety and Depression Scale (HADS)

  13. Anxiety/Depression Scale

    Time frame: 6 months after treatment end

    Hospital Anxiety and Depression Scale (HADS)

  14. Function

    Time frame: Treatment end, an average of 5 months

    Patient-specific Functional Scale (PSFS)

  15. Function

    Time frame: 6 months after treatment end

    Patient-specific Functional Scale (PSFS)

  16. Self-Efficacy

    Time frame: Treatment end, an average of 5 months

    Pain Self-Efficacy Questionnaire (FESS)

  17. Self-Efficacy

    Time frame: 6 months after treatment end

    Pain Self-Efficacy Questionnaire (FESS)

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Acronym: IV

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Apr 20, 2018
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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