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临床试验/NCT04047407
NCT04047407Unknown不适用

Pain Response Characteristics to Different Doses of Suprathreshold Pressure Stimulation in Fibromyalgia Subjects

University of Castilla-La Mancha1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年6月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
52
试验地点
1
主要终点
Referred pain induced area after suprathreshold pressure stimulation

研究概览

简要总结

The purpose of this study is to investigate the induced-pain characteristics after suprathreshold pressure stimulation at different intensities in fibromyalgia subjects, compared with healthy volunteers.

详细描述

Fibromyalgia syndrome is a chronic painful, non-inflammatory rheumatic disease with a high negative impact on the quality of life, and is characterized by widespread pain, fatigue and generalised hyperalgesia on examination, symptoms that can be the consequence of central sensitization.

Despite several methods have successfully addressed this increased responsiveness of nociceptive neurons in the central nervous system, there is a lack of consensus about how to systematically perform them and those that are more appropriated for different syndromes. Therefore, investigating appropriate simple methods to assess clinical manifestations of central sensitization is relevant in the assessment of fibromyalgia.

The present study aims to investigate the pain response after suprathreshols pressure stimulation in fibromyalgia subjects compared with healthy volunteers.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 80 years
  • Fullfilled the American Collegue of Rheumathology criteria for fibromyalgia.
  • Understanding of spoken and written Spanish.

排除标准

  • Diagnosed psychiatric pathology.
  • Rheumatic pathology not medically controlled.

结局指标

主要结局

Referred pain induced area after suprathreshold pressure stimulation

时间窗: Inmediately after each stimulation

After each stimulation (120%, 130%, 140% and 150%), the subject should draw the induced pain area on a digital bodychart using the Navigate Pain application (Navigate Pain, Aalborg University, Denmark). The size of the areas of referred pain will be extracted in pixels.

次要结局

  • Pain intensity(Inmediately after each stimulation)
  • Body regions afected by pain after suprathreshold pressure stimulation(Inmediately after each stimulation)

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

研究点 (1)

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