Shearwave Elastography in the Evaluation of Iliotibial Band Syndrome

May 15, 2023 updated by: Nathaly Gaudreault, Université de Sherbrooke

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H5N4
        • Sonia Bédard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All runners from Sherbrooke available during the recruitment period will be invited to participate

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
asymptomatic
Runners without iliotibial band syndrome
Iliotibial band syndrome
Runners with iliotibial band syndrome

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Through study completion, an average of 9 months
Proportion of included participants / total of contacts
Through study completion, an average of 9 months
Exclusion rate
Time Frame: Through study completion, an average of 9 months
Proportion of excluded participants / total of contacts
Through study completion, an average of 9 months
Refusal rate
Time Frame: Through study completion, an average of 9 months
Proportion of participants who refused to participate / total of contacts
Through study completion, an average of 9 months
Lenght of the procedure
Time Frame: Baseline
Time for each evaluation in minutes
Baseline
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
Through study completion, an average of 9 months
Acceptability of the procedure
Time Frame: Baseline
opinion of participant regarding lenght of the procedure, unconfort or pain during the procedure
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Morphometric ITB measures
Time Frame: Baseline
Thickness of distal iliotibial band with mode B ultrasound in millimeter
Baseline
Stiffness of ITB
Time Frame: Baseline
Stiffness of mid and distal ITB using SWE in kPa or m/s
Baseline
Stiffness of TFL
Time Frame: Baseline
Stiffness of TFL muscle belly using SWE in kPa or m/s
Baseline
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
Baseline
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.
Baseline
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
Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Sherbrooke

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathaly Gaudreault, Pt, Ph.D, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-4344

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings