Effects of Multimodal Treatment of Headache in a Day Clinic Service
- Conditions
- Headache Disorders
- Interventions
- Other: multimodal treatment
- Registration Number
- NCT05111873
- Lead Sponsor
- University Medicine Greifswald
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- diagnosis of a headache disorder
- written informed consent for collecting and analysing data and conducting a follow-up evaluation
- premature interruption of the treatment
- repeated treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description post-treatment group multimodal treatment Participants enquired after the treatment in the Neurological day clinic service
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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 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 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
Trial Locations
- Locations (1)
Department of Neurology
🇩🇪Greifswald, Mecklenburg-Vorpommern, Germany