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临床试验/NCT03890393
NCT03890393已完成不适用

Muscle Activity of Pericranial Muscles in Patients With Episodic or Chronic Headache vs Asymptomatic Controls: a Cross-sectional Study

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年1月1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
55
试验地点
1
主要终点
Pericranial muscle activity

研究概览

简要总结

Through an observational, cross-sectional study, muscle activity was compared among 21 subjects with episodic headache, 17 subjects with chronic headache and 17 age-matched healthy controls. Muscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid (SCM), splenius capitis, splenius cervicis and trapezius of each subject. Headache characteristics (intensity, frequency and duration), McGill Pain Questionnaire (MPQ) and Digital Span (DS) scales were secondary outcomes. The correlation between muscle activity and headache characteristics was also analyzed.

This study provides preliminary evidence of the relationship between muscle and the chronicity of headache.

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

  • Have at least one onset of headache in the last week,
  • Aged between 18-65 years,
  • No special treatment or invasive test on pericranial muscles in the last month, and no painkillers or muscle relaxants in the last week.

排除标准

  • History of surgery, trauma, tumor and spinal disease affecting the head and neck,
  • Being unable to cooperate with inspection and questionnaires for any reason (severe systemic disease, bleeder, communication barriers and so on),
  • People with definite mental disorders such as anxiety and depression.

结局指标

主要结局

Pericranial muscle activity

时间窗: On the day the participant was enrolled

It was evaluated with EMG/EP equipment(9031A070 KEYPOINT Dantec) and the matching disposable needle electrode(Specification: 25mm\*0.3mm, 30G) with a sampling frequency of 125 Hz and a measuring range of 0.2mv.The spontaneous electric activity of each pericranial muscle was recorded as 0 to 4 scores: 0 score= no repeatable spontaneous electric activity, 1 score=a single, repeatable string of spontaneous electric activity, 2 scores= obvious spontaneous electric activity in two or more areas of the muscle, 3 scores= obvious spontaneous electric activity in any area of the muscle, 4 scores= a lot of spontaneous electric activity over the whole record screen. The maximum scores of a participant was 48(6\*2\*4[insertion(frontal, temporal, sternocleidomastoid, splenius capitis, splenius cervicis and trapezius) \*right or left\* maximum scores of a muscle\]).

次要结局

  • Short Form of the McGill Pain Questionnaire(SF-MPQ)(Immediately after the enrollment)
  • Digital Span Test(Immediately after the enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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