Headache Disorders
Conditions
Keywords
multimodal treatment, quality of life, day clinic service
Brief summary
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
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
Interventions
OTHERmultimodal treatment
combination of medical consultations, psychological therapy, physiotherapy, occupational therapy, disease specific education und progressive muscle relaxation
Sponsors
University Medicine Greifswald
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Veterans RAND 12 Item Health Survey (VR-12) mental health score | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Depression Anxiety and Stress Scale (DASS) | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment | 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 |
| Change of Headache Impact Test (HIT6) | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment | questionnaire, patient self-report, minimum value: 36 points, maximum value: 78 points, higher score = worse outcome |
| Change of Headache frequency | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment | in days per month, referring to the last month, minimum value: 0 days/month, maximum value: 30 days/month |
| Change of Veterans RAND 12 Item Health Survey (VR-12) physical health score | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment | 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 |
| Change of Pain intensity | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment | average pain intensity in the last month, scale 1 to 10, higher score = worse outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of Veterans RAND 12 Item Health Survey (VR-12) single domains | 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment | 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 |
Countries
Germany
Contacts
Primary ContactRobert Fleischmann, MD
Outcome results
None listed