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临床试验/NCT03626805
NCT03626805已完成不适用

Muscle Tenderness and Hardness in Migraine Patients

Danish Headache Center1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2017年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
1
主要终点
Logistic regression model, Neck Stiffness

研究概览

简要总结

The aim of the study is to examine symptomatology, quantitative sensory test (QST) parameters, muscle tenderness and muscle hardness in migraine patients interictally and compare with healthy controls

详细描述

Migraine patients exhibit different symptomatology and responses to treatment. For example do many migraine patients have neck symptoms, despite they apparently do not have any neck disorders.Furthermore the response to treatment differs between patients. Differences in symptomatology, QST parameters and muscle stiffness can be used to subdivide and phenotype migraine patients.

The investigators are examining migraine patients with:

A semistructured interview, Quantitative sensory testing (cold pain threshold, heat pain threshold and Pin Prick), Muscle tenderness (total tenderness score, local tenderness score and stimulus response curve), and muscle hardness with ultrasound elastography. All tests are performed the same day

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • Migraine Patients from the Danish Headache Centre. Migraine classified using the International Classification of Headache Disorders (ICHD3) criteria.

排除标准

  • Pregnant or lactating women
  • Musculoskeletal injuries in the neck or shoulder
  • Other primary headache disorders than migraine or Tension Type Headache
  • On the time of examination: Migraine free for at least 48 hours
  • On the time of examination: haven't trained the upper body for at least 48 hours
  • On the time of examination: haven't used painkillers for at least 48 hours
  • Healthy controls:
  • Exclusion Criteria:
  • Pregnant or lactating women
  • Musculoskeletal injuries in the neck or shoulder
  • Migraine disorders
  • degree relatives with migraine disorders
  • Over 1 day of tension type headache a month.
  • On the time of examination: haven't trained the upper body for at least 48 hours
  • On the time of examination: haven't used painkillers for at least 48 hours

结局指标

主要结局

Logistic regression model, Neck Stiffness

时间窗: 3 hours

We would like to examine the relationship between the variable variable: Neck stiffness during migraine attack (Yes/No) and the Independent variables: Total Tenderness Score (summed score from 8 points bilateral, each point can score 0-3), Migraine localisation (occipital: Yes/No), Tension Type Headache, Allodynia (yes/No), Stimulus response curve (Pressure and Pain). The result shows how much of the variability in neck stiffness that can be explained by the independent variables.

Muscle hardness measured by ultrasound elastography in migaine patients

时间窗: 3 hours

Muscle hardness (m/s) in migraine patients with neck stiffness during migraine attacks compared to migraine patients without neck stiffness during migraine attacks. Corrected for age, BMI and sex.

Muscle Hardness measured by ultrasound elastography

时间窗: 3 hours

Muscle hardness (m/s) in migraine patients compared to healthy controls.corrected for age, BMI and sex

Pericranial Muscle Tenderness

时间窗: 3 hours

We will examine whether patients with neck stiffness during migraine attack (yes/no) have higher tenderness scores compared to patients without neck stiffness during migraine attacks, when correcting for headache frequency.

次要结局

  • Next migraine attack, Cox proportional hazards model(3 hours)
  • Multiple Regression model, Total Tenderness Score(3 hours)
  • Logistic regression model, Neck pain in general(3 hours)

研究者

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

Jeppe Hvedstrup Mann

PhD Student

Danish Headache Center

研究点 (1)

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