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临床试验/NCT05427110
NCT05427110已完成不适用

Cross-sectional Study to Assess Iliotibial Band Morphometry and Stiffness Using Ultrasound Imaging in Runners With and Without Symptoms of Iliotibial Band Syndrome: a Feasibility Study

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年5月5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
48
试验地点
1
主要终点
Acceptability of the procedure

研究概览

简要总结

Iliotibial band syndrome (ITBS) is a condition frequently treated in physiotherapy. The pathophysiology underlying this syndrome is still poorly understood. Ultrasound makes it possible to evaluate the morphology and to quantify, with sonoelastography (SWE), the stiffness of the iliotibial band (ITB). The objective is to determine the feasibility of a cross-sectional study aimed at evaluating the morphometry and stiffness of the ITB in runners with and without a diagnosis of ITBS. Socio-demographic and clinical data will be collected and ultrasound measurements (thickness and stiffness) of the iliotibial band will be performed in supine with the knee positioned at 2 different angles (0° and 30° flexion). Variables such as the recruitment rate/month, the inclusion/exclusion rate, the acceptability of the procedure will be used to characterize the feasibility. The relationship between ultrasound measurements and clinical outcomes will be explored. The results obtained will document feasibility issues and provide preliminary results will lay the groundwork for a large scale study.

详细描述

The iliotibial band (ITB) is a complex structure in which morphometry (shape, thickness, cross-sectional area) and viscoelastic properties remain poorly understood. While some hypothesize that the pain originates from friction of the ITB on the femoral condyle during knee flexion, others affirm that it is rather a compression of the ITB on the tissue underlying fat, which is highly vascularized and innervated. Current treatments in physiotherapy are based, in part, on the theory that stiffness in the ITB may contribute to iliotibial band syndrome (ITBS), resulting in prescription of stretching exercises in most rehabilitation programs. However, the plausibility of this theory remains to be demonstrated with valid and reliable instruments. Standard-mode (B-mode) ultrasound is gaining popularity for assessing ITB morphometry. However, these data remain to be correlated with the clinical symptomatology. Sonoelastography (SWE), on the other hand, is used to assess tissue stiffness. Recent studies have attempted to assess the stiffness of ITB under different experimental conditions, but these have methodological flaws (low power) and they are carried out in an asymptomatic population. This project is a first step to fill the gaps on ITB morphometry and stiffness values and explore the potential association between these factors and the clinical profile of SBIT. The primary objective is to evaluate the study the feasibility of the protocol by documenting the variables associated with this concept. Secondary objectives are: 1) To measure the stiffness of the distal BIT in runners with and without ITBS; 2) Describe the morphometry of the distal BIT in the two groups of runners; 3) Compare ITB morphometry and stiffness between the two groups of runners and 4) Investigate the association between ultrasound variables and ITBS signs and symptoms.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Minimum of 5km/week runs
  • No pain during running (for healthy runners)
  • For ITBS group: Received an ITBS diagnosis from a doctor or a physical therapist

排除标准

  • Concomitant affection of the hip or knee (ex: previous fracture or surgery of the knee)

结局指标

主要结局

Acceptability of the procedure

时间窗: Baseline

opinion of participant regarding lenght of the procedure, unconfort or pain during the procedure

Lenght of the procedure

时间窗: Baseline

Time for each evaluation in minutes

Recruitment rate

时间窗: Through study completion, an average of 9 months

Proportion of included participants / total of contacts

Exclusion rate

时间窗: Through study completion, an average of 9 months

Proportion of excluded participants / total of contacts

Refusal rate

时间窗: Through study completion, an average of 9 months

Proportion of participants who refused to participate / total of contacts

Cost of the study

时间窗: Through study completion, an average of 9 months

Cost of the patients compensation, ultrasounds gel, staff, in Canadian dollars

次要结局

  • Muscle retraction test(Baseline)
  • Morphometric ITB measures(Baseline)
  • Stiffness of TFL(Baseline)
  • Stiffness of ITB(Baseline)
  • Pain intensity(Baseline)
  • Knee pain and function questionnaires(Baseline)

研究者

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

Nathaly Gaudreault

Researcher and Full Professor

Université de Sherbrooke

研究点 (1)

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