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Shearwave Elastography in the Evaluation of Iliotibial Band Syndrome

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05427110
Enrollment
48
Registered
2022-06-22
Start date
2022-05-05
Completion date
2022-09-23
Last updated
2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iliotibial Band Syndrome

Keywords

Iliotibial band syndrome, Stiffness, Sonoelastography

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.

Interventions

None listed

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the procedureBaselineopinion of participant regarding lenght of the procedure, unconfort or pain during the procedure
Recruitment rateThrough study completion, an average of 9 monthsProportion of included participants / total of contacts
Exclusion rateThrough study completion, an average of 9 monthsProportion of excluded participants / total of contacts
Refusal rateThrough study completion, an average of 9 monthsProportion of participants who refused to participate / total of contacts
Lenght of the procedureBaselineTime for each evaluation in minutes
Cost of the studyThrough study completion, an average of 9 monthsCost of the patients compensation, ultrasounds gel, staff, in Canadian dollars

Secondary

MeasureTime frameDescription
Morphometric ITB measuresBaselineThickness of distal iliotibial band with mode B ultrasound in millimeter
Stiffness of ITBBaselineStiffness of mid and distal ITB using SWE in kPa or m/s
Stiffness of TFLBaselineStiffness of TFL muscle belly using SWE in kPa or m/s
Pain intensityBaselineTo 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 questionnairesBaselineTo 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.
Muscle retraction testBaselineTo 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026