Skip to main content
OpenTrials
Completed

NCT Number: NCT05427110

Shearwave Elastography in the Evaluation of Iliotibial Band Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Iliotibial Band Syndrome Cumulative Trauma Disorders Knee Injuries Leg Injuries Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sonia Bédard

Sherbrooke, Quebec, J1H5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Recruitment rate

    Time frame: Through study completion, an average of 9 months

    Proportion of included participants / total of contacts

  2. Exclusion rate

    Time frame: Through study completion, an average of 9 months

    Proportion of excluded participants / total of contacts

  3. Refusal rate

    Time frame: Through study completion, an average of 9 months

    Proportion of participants who refused to participate / total of contacts

  4. Lenght of the procedure

    Time frame: Baseline

    Time for each evaluation in minutes

  5. Cost of the study

    Time frame: Through study completion, an average of 9 months

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

  6. Acceptability of the procedure

    Time frame: Baseline

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

Secondary outcomes

  1. Morphometric ITB measures

    Time frame: Baseline

    Thickness of distal iliotibial band with mode B ultrasound in millimeter

  2. Stiffness of ITB

    Time frame: Baseline

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

  3. Stiffness of TFL

    Time frame: Baseline

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

  4. Pain intensity

    Time frame: Baseline

    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

  5. Knee pain and function questionnaires

    Time frame: Baseline

    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.

  6. Knee pain and function questionnaires

    Time frame: Baseline

    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

  7. Muscle retraction test

    Time frame: Baseline

    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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2022
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.