Effects of Multimodal Treatment of Headache in a Day Clinic Service

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effects of Multimodal Treatment of Headache in a Day Clinic Service: a Prospective Case-crossover Study

Conditions
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Headache Disorders

Intervention / Treatment
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* Other: multimodal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of a headache disorder written informed consent for collecting and analysing data and conducting a follow-up evaluation Exclusion Criteria: premature interruption of the treatment repeated treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| waiting-list control<br>Participants enquired prior to the treatment appointment in the neurological day clinic service, no intervention | |
| post-treatment group<br>Participants enquired after the treatment in the Neurological day clinic service | Other: multimodal treatment<br>* combination of medical consultations, psychological therapy, physiotherapy, occupational therapy, disease specific education und progressive muscle relaxation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, day clinic service, multimodal treatment