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.
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.
Study Type
OBSERVATIONAL
Enrollment
158
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.
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, North Rhine-Westphalia, Germany
Headache frequency
Headache days/month
Time frame: Treatment end, an average of 5 months
Headache frequency
Headache days/month
Time frame: 6 months after treatment end
Pain intensity
100mm visual analog scale
Time frame: Treatment end, an average of 5 months
Pain intensity
100mm visual analog scale
Time frame: 6 months after treatment end
Pain bothersomeness
100mm visual analog scale
Time frame: Treatment end, an average of 5 months
Pain bothersomeness
100mm visual analog scale
Time frame: 6 months after treatment end
Pain perception
Pain Perception Scale
Time frame: Treatment end, an average of 5 months
Pain perception
Pain Perception Scale
Time frame: 6 months after treatment end
Quality of life
SF-12
Time frame: Treatment end, an average of 5 months
Quality of life
SF-12
Time frame: 6 months after treatment end
Headache Disability
Headache Disability Inventory (HDI)
Time frame: Treatment end, an average of 5 months
Headache Disability
Headache Disability Inventory (HDI)
Time frame: 6 months after treatment end
Anxiety/Depression Scale
Hospital Anxiety and Depression Scale (HADS)
Time frame: Treatment end, an average of 5 months
Anxiety/Depression Scale
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months after treatment end
Function
Patient-specific Functional Scale (PSFS)
Time frame: Treatment end, an average of 5 months
Function
Patient-specific Functional Scale (PSFS)
Time frame: 6 months after treatment end
Self-Efficacy
Pain Self-Efficacy Questionnaire (FESS)
Time frame: Treatment end, an average of 5 months
Self-Efficacy
Pain Self-Efficacy Questionnaire (FESS)
Time frame: 6 months after treatment end
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