- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05427110
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
- Name: Sonia Bédard
- Phone Number: 13927 1-819-346-1110
- Email: sonia.bedard2@usherbrooke.ca
Study Contact Backup
- Name: Nathaly Gaudreault, Pt, Ph.D
- Email: nathaly.gaudreault@usherbrooke.ca
Study Locations
-
-
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
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 |
---|
asymptomatic
Runners without iliotibial band syndrome
|
Iliotibial band syndrome
Runners with iliotibial band syndrome
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
May 5, 2022
Primary Completion (Actual)
September 23, 2022
Study Completion (Actual)
September 23, 2022
Study Registration Dates
First Submitted
June 13, 2022
First Submitted That Met QC Criteria
June 16, 2022
First Posted (Actual)
June 22, 2022
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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