Shearwave Elastography in the Evaluation of Iliotibial Band Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Iliotibial Band Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Concomitant affection of the hip or knee (ex: previous fracture or surgery of the knee)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| asymptomatic<br>Runners without iliotibial band syndrome | |
| Iliotibial band syndrome<br>Runners with iliotibial band syndrome | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Proportion of included participants / total of contacts | Through study completion, an average of 9 months | 
| Exclusion rate | Proportion of excluded participants / total of contacts | Through study completion, an average of 9 months | 
| Refusal rate | Proportion of participants who refused to participate / total of contacts | Through study completion, an average of 9 months | 
| Lenght of the procedure | Time for each evaluation in minutes | Baseline | 
| Cost of the study | Cost of the patients compensation, ultrasounds gel, staff, in Canadian dollars | Through study completion, an average of 9 months | 
| Acceptability of the procedure | opinion of participant regarding lenght of the procedure, unconfort or pain during the procedure | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphometric ITB measures | Thickness of distal iliotibial band with mode B ultrasound in millimeter | Baseline | 
| Stiffness of ITB | Stiffness of mid and distal ITB using SWE in kPa or m/s | Baseline | 
| Stiffness of TFL | Stiffness of TFL muscle belly using SWE in kPa or m/s | Baseline | 
| Pain intensity | To assess pain intensity using a Numerical Rating Scale (NRS), 0 to 10 in which 0 mean no pain and 10, the worst pain ever feeled | Baseline | 
| Knee pain and function questionnaires | To assess knee pain and function using the Anterior knee pain scale (AKPS). 13 questions with a total score of 100 that mean an excellent function. | Baseline | 
| Knee pain and function questionnaires | To assess knee pain and function using the Lower Extremity Functional Scale (LEFS) with 20 questions with a total score of 80 that mean an excellent function | Baseline | 
| Muscle retraction test | To assess retraction of Tensor Fascia Lata(TFL) muscle using Modified Ober Test. Score will be measure with an inclinometer in degree of the hip adduction | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iliotibial band syndrome, Stiffness, Sonoelastography