Integrated Care for Migraine and Chronic Tension-type Headaches

Study Overview
=================
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.

Official Title
-----------------
Integrated Care for Migraine and Chronic Tension-type Headaches

Conditions
-----------------
Chronic Headache

Intervention / Treatment
-----------------
* Behavioral: Integrated headache care


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Integrated headache care<br>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. | Behavioral: Integrated headache care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency | Headache days/month | Treatment end, an average of 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency | Headache days/month | 6 months after treatment end | 
| Pain intensity | 100mm visual analog scale | Treatment end, an average of 5 months | 
| Pain intensity | 100mm visual analog scale | 6 months after treatment end | 
| Pain bothersomeness | 100mm visual analog scale | Treatment end, an average of 5 months | 
| Pain bothersomeness | 100mm visual analog scale | 6 months after treatment end | 
| Pain perception | Pain Perception Scale | Treatment end, an average of 5 months | 
| Pain perception | Pain Perception Scale | 6 months after treatment end | 
| Quality of life | SF-12 | Treatment end, an average of 5 months | 
| Quality of life | SF-12 | 6 months after treatment end | 
| Headache Disability | Headache Disability Inventory (HDI) | Treatment end, an average of 5 months | 
| Headache Disability | Headache Disability Inventory (HDI) | 6 months after treatment end | 
| Anxiety/Depression Scale | Hospital Anxiety and Depression Scale (HADS) | Treatment end, an average of 5 months | 
| Anxiety/Depression Scale | Hospital Anxiety and Depression Scale (HADS) | 6 months after treatment end | 
| Function | Patient-specific Functional Scale (PSFS) | Treatment end, an average of 5 months | 
| Function | Patient-specific Functional Scale (PSFS) | 6 months after treatment end | 
| Self-Efficacy | Pain Self-Efficacy Questionnaire (FESS) | Treatment end, an average of 5 months | 
| Self-Efficacy | Pain Self-Efficacy Questionnaire (FESS) | 6 months after treatment end |