Shearwave Elastography in the Evaluation of Iliotibial Band Syndrome

Iliotibial Band Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427110
• Other study ID #: 2022-4344
• Status: Completed
• Start date: May 5, 2022
• Est. completion date: September 23, 2022

Study information

• Verified date: May 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 23, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Iliotibial Band Syndrome
• Syndrome

Locations

Country	Name	City	State
Canada	Sonia Bédard	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Proportion of included participants / total of contacts	Through study completion, an average of 9 months
Primary	Exclusion rate	Proportion of excluded participants / total of contacts	Through study completion, an average of 9 months
Primary	Refusal rate	Proportion of participants who refused to participate / total of contacts	Through study completion, an average of 9 months
Primary	Lenght of the procedure	Time for each evaluation in minutes	Baseline
Primary	Cost of the study	Cost of the patients compensation, ultrasounds gel, staff, in Canadian dollars	Through study completion, an average of 9 months
Primary	Acceptability of the procedure	opinion of participant regarding lenght of the procedure, unconfort or pain during the procedure	Baseline
Secondary	Morphometric ITB measures	Thickness of distal iliotibial band with mode B ultrasound in millimeter	Baseline
Secondary	Stiffness of ITB	Stiffness of mid and distal ITB using SWE in kPa or m/s	Baseline
Secondary	Stiffness of TFL	Stiffness of TFL muscle belly using SWE in kPa or m/s	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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