跳至主要内容
临床试验/NCT05677204
NCT05677204招募中不适用

Factors Predicting the Course of Acute Achilles Tendinopathy in Runners

Laval University1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
95
试验地点
1
主要终点
Victorian Institute of Sports Assessment for Achilles tendinopathy (VISA-A) questionnaire

研究概览

简要总结

Achilles tendinopathy is highly prevalent in runners, but its evolution is not easily predictable. The aim of this study is to evaluate the impact of clinical and social factors on the prognosis of acute (less than 3 months) Achilles tendinopathy in runners. Runners will be evaluated in person twice. At their first visit, data related to their training (frequency, intensity, ...), their running pattern (cadence, foot contact angle) and shoes (minimalist index) will be collected. Moreover, an ultrasound evaluation of Achilles tendon will be performed. At one, two and three months after their initial evaluation, participants will receive a link to complete an online survey about their pain. Three months after their initial evaluation, a second ultrasound of Achilles tendon will be performed.

详细描述

At their first visit, participants will read and sign the consent form. They will then fill self-report questionnaires about their pain (using the Victorian Institute of Sport Assessment for Achilles tendinopathy score and visual analog scale) and its impact on their activities, and they will be questioned on their training habits. Then, participants will be asked to run on a treadmill for five minutes at a comfortable speed. During the run, video will be recorded to evaluate to cadence and the foot contact angle. Finally, an ultrasound of Achilles tendon will be performed to evaluate thickness, area, echogenicity and inflammation of the tendon. All the images will be revised by a physician qualified in diagnostic ultrasound and the tendinopathy will be graded according to Matthew and al. model.

One, two and three months after their initial visit, participants will receive a questionnaire by email to quantify their pain. Moreover, three months after their initial visit, participants will come back in person to the laboratory. Information about their pain, training and treatment will be collected and a second ultrasound analysis will be performed.

Statistical analysis

Baseline data will be compared using independent t-test or a Mann-Whitney U test. Significant variables in the univariate analysis will be considered as potential predictor variables. Logistic analysis regression will then be performed to identify predictive factors for pain chronicity.

研究设计

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

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

  • Have Achilles tendon pain for less than three months
  • Run at least five kilometers per week
  • Have a score on the Victorian Institute of Sports Assessment of Achilles tendinopathy of 80 or less
  • Consent to the study

排除标准

  • History of Achilles tendon surgery or rupture

结局指标

主要结局

Victorian Institute of Sports Assessment for Achilles tendinopathy (VISA-A) questionnaire

时间窗: At three months

Pain impact score between 0 (heavily affected) and 100 (asymptomatic)

Pain graded on the visual analog scale

时间窗: At three months

Pain graded on a 0 to 10 visual analog scale

次要结局

  • Area of the Achilles tendon(At three months)
  • Thickness of the Achilles tendon(At three months)
  • Aspect of the tendon at ultrasound evaluation graded according to Matthew and al(At three months)

研究者

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

Jean-Sébastien Roy

Principal Investigator

Laval University

研究点 (1)

Loading locations...

相似试验