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临床试验/NCT03506464
NCT03506464已完成不适用

Short-term Effects of a Myofascial Release on Elasticity in Patients With Plantar Fasciitis: A Pre-post Evaluation With Sonoelastography

Universidad de Murcia2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Changes in echointensity

研究概览

简要总结

Background: Plantar fasciitis is the most common cause of heel pain in runners. No studies have described the short-term effects of myofascial release on plantar fasciitis using ultrasound.

Objectives: To describe the immediate sonoelastographic changes in the plantar fascia of amateur runners with fasciitis after applying a myofascial release technique.

Design: A single-centre, experimental and controlled study.

Method: Patients with plantar fasciitis and a group of healthy subjects will be examined using B-mode and real time sonoelastography scanning. Fascia thickness, echointensity and echovariation of the color histogram will be analyzed pre- and post intervention. A two-way (Group × Time) repeated measures ANOVA will be performed.

详细描述

Participants

Subjects of the plantar fasciitis group (PFG) will be recruited in May2018 to apply to them a myofascial release technique.

Healthy volunteers without a history of plantar fascia disease will be recruited as control group (CG).

The examination will be included B-mode scanning and real time sonoelastography using an US scanner with linear array transducer (ML6-15). All examinations will be conducted by a sonographer with more than 10 years' experience in musculoskeletal imaging.

Using a standardized protocol three images of every pre-post intervention video will be stored uncompressed and with no losses in bitmap format (bmp), and the mean value of the histogram components will be used for statistical analysis. The examination protocol shows good reliability, and has been reported previously.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • heel pain at the proximal fascia insertion
  • worse pain when waking up in the morning or after a period of rest
  • a visual analog score (VAS) of more than 4 on a scale of 10

排除标准

  • Patients who had undergone surgery or steroid injections to the heel will be excluded.

研究组 & 干预措施

plantar fasciitis group

Experimental

Myofascial release technique

干预措施: Myofascial Release Technique (Procedure)

control group

No Intervention

None of the control group received the treatment

结局指标

主要结局

Changes in echointensity

时间窗: Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.

The EI of the color histogram computed the mean value of intensity of red, green and blue channels (color intensity range, 0-255) within a given area

Changes in Echovariation

时间窗: Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.

Determined as the relation between standard deviation and mean of pixel intensity obtained from the histogram

Changes in thickness of the plantar fascia

时间窗: Measured twice. pre and post treatment. Post treatment examination will be carried out 10 minutes after the intervention concludes.

Measured from the anterior edge of the inferior calcaneal border vertically to the inferior border of the plantar fascia

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

María Elena del Baño-Aledo

Principal Investigator

Universidad de Murcia

研究点 (2)

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