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临床试验/NCT05906901
NCT05906901尚未招募不适用

Effects of Osteopathic Treatment in Patients With Tension Type Headache

Escola Superior de Tecnologia da Saúde do Porto2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Frequency

研究概览

简要总结

The aim of this study is to evaluate the effects of the suboccipital muscles inhibition technique on patients suffering from tension-type headaches.

详细描述

The tension-type headache is a recurrent condition with a high financial repercussion in Portugal. Their side effects often impact daily activities, reducing the quality of life of the patients.

In several studies, the excessive tension of the suboccipital muscles are usually referred as a cause of tension-type headache, since they can exert tension on the dura mater through the myodural bridge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • They must have tension-type headache, that is, a headache with:
  • a duration of at least 30 min to days, with or without an break;
  • must have at least two of the following four characteristics:
  • bilateral location
  • pressure or squeezing quality (non throbbing)
  • weak or moderate intensity
  • not aggravated by routine physical activity such as walking or climbing stairs;
  • must have both of the following criteria:
  • only one of the following: photophobia, phonophobia, or mild nausea
  • absence of moderate or severe nausea or vomiting.

排除标准

  • They can't be on antibiotics, antivirals, or antidepressants;
  • They can't have neurological problems;
  • They shouldn't have any absolute contraindication for the osteopathic maneuvers;
  • They can't have acute pathologies (ex: infection) or serious (ex: cancer);
  • They can't have fractures in the skull, cervical spine or high dorsal spine (up to D4);
  • They can't be pregnant.

结局指标

主要结局

Frequency

时间窗: One month after first intervention

Measured by monthly counting.

Intensity

时间窗: One month after first intervention

Measured by visual analogue scale (VAS). It goes from 0 to 10, 0 being the minimum pain intensity and 10 the maximum pain intensity.

Impact on quality of life questionnaire

时间窗: one month after first intervention

Measured by questionnaire. The questionnaire attribuates a score after answering six questions. The lowest score a participant can obtain is 36, which corresponds to the lowest impact on quality of life. The highest score a participant can obtain is 78, which corresponds to the highest impact on quality of life.

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

Natália Maria Oliveira Campelo

Professor

Escola Superior de Tecnologia da Saúde do Porto

研究点 (2)

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