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The observational study aims to investigate the effects of a multimodal treatment program for headache patients in a day clinic service. The setting provides one week of treatment including a combination of medical consultation, physiotherapy, psychological therapy, occupational therapy, progressive muscle relaxation and disease specific education.
Outcome measures are the disease-specific impact on daily activities, general quality of life, psychological impact and headache frequency. Moreover, the study sought to identify parameters that best predict efficacy of the intervention. Therefore, standardized questionnaires are established in three points in time, to evaluate the pre- and post-treatment status.
duration of treatment: 5 days; first questionnaire (V0): minimal 4 weeks prior to the treatment appointment; second questionnaire (V1): on the first day of the treatment program; third questionnaire (V2 / Follow up): 3 month (+- 6 weeks) after finishing the treatment; data collection through patient self-report; Follow-up via mail
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| waiting-list control | Participants enquired prior to the treatment appointment in the neurological day clinic service, no intervention | ||
| post-treatment group | Participants enquired after the treatment in the Neurological day clinic service |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multimodal treatment | Other | combination of medical consultations, psychological therapy, physiotherapy, occupational therapy, disease specific education und progressive muscle relaxation |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Veterans RAND 12 Item Health Survey (VR-12) mental health score | questionnaire, patient self-report, 12 questions, minimum value: 12 points, maximum value: 54 points, physical and mental health component summary score compared to a t-score with a mean value of 50 and standard deviation of 10 | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Depression Anxiety and Stress Scale (DASS) | questionnaire, patient self-report, 21 questions, 7 questions per subscale (Depression, Anxiety and Stress), minimum value: 0 points, maximum value: 21 points per subscale, higher score = worse outcome | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Veterans RAND 12 Item Health Survey (VR-12) single domains | questionnaire, patient self-report, 12 questions, minimum value: 12 points, maximum value: 54 points, physical and mental health component summary score compared to a t-score with a mean value of 50 and standard deviation of 10 | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment |
Inclusion Criteria:
Exclusion Criteria:
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All patients seen in the neurological day clinic service will be screened for eligibility.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Fleischmann, MD | Contact | +493834866778 | robert.fleischmann@uni-greifswald.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology | Recruiting | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
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| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Change of Headache Impact Test (HIT6) | questionnaire, patient self-report, minimum value: 36 points, maximum value: 78 points, higher score = worse outcome | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment |
| Change of Pain intensity | average pain intensity in the last month, scale 1 to 10, higher score = worse outcome | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment |
| Change of Headache frequency | in days per month, referring to the last month, minimum value: 0 days/month, maximum value: 30 days/month | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment |
| Change of Veterans RAND 12 Item Health Survey (VR-12) physical health score | questionnaire, patient self-report, 12 questions, minimum value: 12 points, maximum value: 54 points, physical and mental health component summary score compared to a t-score with a mean value of 50 and standard deviation of 10 | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment |