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临床试验/NCT05785650
NCT05785650尚未招募不适用

Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation

Institut des Hautes Etudes Osteopathiques de Nantes0 个研究点目标入组 61 人开始时间: 2023年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
61
主要终点
sensitivity and specificity of osteopathic tests

研究概览

简要总结

Trigger points (TP) are described as "hard, palpable nodules located within the taut bands of skeletal muscle" (Bardoni, 2022).

The aim of this study is to evaluate the reproductibility of palpation of TP between osteopaths and to compare this perception to ultrasound measures of echogenicity.

Method:

A sample of 61 patients will be included in the study. An osteopath will determine the eligibility of the study. The supraclavicular area will be mark every 2 cm to establish a grid for all evaluations.

First an osteopath will evaluate with palpation the presence of TP at every box of the grid.

A second osteopath will evaluate the same boxes and will be blinded to the result of the first osteopath.

At each step of palpation, a pain assessment will be carried out at each box. Then, the ultrasound technician will evaluate the echogeneicity of every box and will be blinded to the prior results.

The protocol will be approve by a french ethic committee.

详细描述

sensitivity and specificity of osteopathic tests will be conducted in comparaison to echograph results (a binary outcomes assessing the presence of an hypoechogenicity).

The reproductibility of osteopaths' tests will be be calculated using Cohen's kappa weighted by the distance between the TPs found.

Finally, the pain reported by patients on areas with a TP defined by the osteopath, and the pain reported by patients on areas without a TP defined by the osteopath will be compared using a student test.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18 to 50 years old),
  • affiliation to a social security scheme or beneficiary of such a scheme

排除标准

  • pregnant and breastfeeding women,
  • adults under guardianship and protected patients.
  • History of integumentary or muscular involvement in the area of interest
  • Allergic reaction
  • wish to stop the study

结局指标

主要结局

sensitivity and specificity of osteopathic tests

时间窗: at day 1

to compare osteopath TP detection to ultrasound echogenicity

次要结局

  • camparison of pain reported by patient with TP detection by osteopath(at day 1)
  • Inter examiner reproductibility of TP detection(at day 1)

研究者

发起方
Institut des Hautes Etudes Osteopathiques de Nantes
申办方类型
Other
责任方
Sponsor

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