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Shearwave Elastography in the Evaluation of Iliotibial Band Syndrome

Completed
Conditions
Iliotibial Band Syndrome
Registration Number
NCT05427110
Lead Sponsor
Université de Sherbrooke
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Acceptability of the procedureBaseline

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

Lenght of the procedureBaseline

Time for each evaluation in minutes

Recruitment rateThrough study completion, an average of 9 months

Proportion of included participants / total of contacts

Exclusion rateThrough study completion, an average of 9 months

Proportion of excluded participants / total of contacts

Refusal rateThrough study completion, an average of 9 months

Proportion of participants who refused to participate / total of contacts

Cost of the studyThrough study completion, an average of 9 months

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

Secondary Outcome Measures
NameTimeMethod
Muscle retraction testBaseline

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

Morphometric ITB measuresBaseline

Thickness of distal iliotibial band with mode B ultrasound in millimeter

Stiffness of TFLBaseline

Stiffness of TFL muscle belly using SWE in kPa or m/s

Stiffness of ITBBaseline

Stiffness of mid and distal ITB using SWE in kPa or m/s

Pain intensityBaseline

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

Knee pain and function questionnairesBaseline

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

Trial Locations

Locations (1)

Sonia Bédard

🇨🇦

Sherbrooke, Quebec, Canada

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