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临床试验/NCT05328635
NCT05328635已完成不适用

The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache

Danish Headache Center1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年9月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Change in headache days

研究概览

简要总结

The study will investigate the effect of pharmacological preventive treatment, education, physiotherapy and psychological counselling on the headache and associated symptoms in patients refered to the Danish Headache Center

详细描述

Pharmacological interventions are candesartan, amitritylin and gabapentin depending on the headache phenotype. In total 3 visits spanned over 1 year

Education is conducted as group sessions of up to 10 patients by two specialist nurses 2 x 90 min Physiotherapy is conducted as group sessions of up to 5 patients by physiotherapists 8 x 60 min plus 2 individual sessions.

Psychology is conducted as group sessions of up to 10 patients by psychologist 3x60 min plus option of 1 individual session.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Patients with post-traumatic headache

排除标准

  • Medication-overuse headache

结局指标

主要结局

Change in headache days

时间窗: 1 year

Headache days will be obtained via a validated questionaire

Rivermead post-concussion questionare score

时间窗: 1 year

Rivermead is a validated questionaire to assess concussion symptoms

HADS-scores

时间窗: 1 year

HADS = Hospital anxiety and depression scale. A validated tool to assesss depression and anxiety symptoms

Self-perceived health

时间窗: 1 year

based on EU-SILC validated question on self-perceived health ('How is your health in general?'), which contains five answering categories; 1) very good, 2) good, 3) fair, 4) bad, 5) very bad.

Level of physical activity

时间窗: 1 year

Based on questionaire, where patients can choose: Low level of physical activity: primarily sedentary activities or light exercise at least 4 hours a week, or

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Henrik Schytz

Principal investigator, MD and associate professor

Danish Headache Center

研究点 (1)

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