Effects of Multimodal Treatment of Headache in a Day Clinic Service: a Prospective Case-crossover Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of Veterans RAND 12 Item Health Survey (VR-12) mental health score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of a headache disorder
- •written informed consent for collecting and analysing data and conducting a follow-up evaluation
排除标准
- •premature interruption of the treatment
- •repeated treatment
结局指标
主要结局
Change of Veterans RAND 12 Item Health Survey (VR-12) mental health score
时间窗: 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
次要结局
- Change of Pain intensity(4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment)
- Change of Headache Impact Test (HIT6)(4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment)
- Change of Depression Anxiety and Stress Scale (DASS)(4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment)
- Change of Headache frequency(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(4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment)