Integrated Care for Migraine and Chronic Tension-type Headaches
- Conditions
- Chronic Headache
- Interventions
- Behavioral: Integrated headache care
- Registration Number
- NCT03503734
- Lead Sponsor
- Universität Duisburg-Essen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
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
None.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Integrated headache care Integrated headache care 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 Outcome Measures
Name Time Method Headache frequency Treatment end, an average of 5 months Headache days/month
- Secondary Outcome Measures
Name Time Method Headache frequency 6 months after treatment end Headache days/month
Pain perception 6 months after treatment end Pain Perception Scale
Function 6 months after treatment end Patient-specific Functional Scale (PSFS)
Pain bothersomeness 6 months after treatment end 100mm visual analog scale
Self-Efficacy 6 months after treatment end Pain Self-Efficacy Questionnaire (FESS)
Pain intensity 6 months after treatment end 100mm visual analog scale
Quality of life 6 months after treatment end SF-12
Headache Disability 6 months after treatment end Headache Disability Inventory (HDI)
Anxiety/Depression Scale 6 months after treatment end Hospital Anxiety and Depression Scale (HADS)
Trial Locations
- Locations (1)
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
🇩🇪Essen, NRW, Germany