Iliotibial Band SyndromeNCT05427110
Shearwave Elastography in the Evaluation of Iliotibial Band Syndrome
An observational study of Iliotibial Band Syndrome, run by Université de Sherbrooke at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Iliotibial Band Syndrome
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 5 May 2022to 23 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All runners from Sherbrooke available during the recruitment period will be invited to participate
Who may be able to join
- 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
Who cannot join
- Concomitant affection of the hip or knee (ex: previous fracture or surgery of the knee)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Iliotibial Band Syndrome
- Keywords
- Iliotibial band syndrome, Stiffness, Sonoelastography
- Medical subject headings
- Iliotibial Band Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| asymptomatic | Runners without iliotibial band syndrome | |
| Iliotibial band syndrome | Runners with iliotibial band syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of included participants / total of contacts
Measured: Through study completion, an average of 9 months
Exclusion rate
Proportion of excluded participants / total of contacts
Measured: Through study completion, an average of 9 months
Refusal rate
Proportion of participants who refused to participate / total of contacts
Measured: Through study completion, an average of 9 months
Lenght of the procedure
Time for each evaluation in minutes
Measured: Baseline
Cost of the study
Cost of the patients compensation, ultrasounds gel, staff, in Canadian dollars
Measured: Through study completion, an average of 9 months
Acceptability of the procedure
opinion of participant regarding lenght of the procedure, unconfort or pain during the procedure
Measured: Baseline
Secondary outcomes (7)
Morphometric ITB measures
Thickness of distal iliotibial band with mode B ultrasound in millimeter
Measured: Baseline
Stiffness of ITB
Stiffness of mid and distal ITB using SWE in kPa or m/s
Measured: Baseline
Stiffness of TFL
Stiffness of TFL muscle belly using SWE in kPa or m/s
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start5 May 2022
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliotibial Band SyndromeStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathaly Gaudreault, Université de Sherbrooke
- Investigators
- Nathaly Gaudreault, Pt, Ph.D, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427110
- Sponsor's protocol ID
- 2022-4344
- Status last verified
- May 2023
- First submitted
- 13 Jun 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05427110
- Acronym / sponsor ID
- 2022-4344
- Conditions
- Iliotibial Band Syndrome
- Keywords
- Iliotibial band syndrome, Stiffness, Sonoelastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asymptomatic | – | –Runners without iliotibial band syndrome |
| Iliotibial band syndrome | – | –Runners with iliotibial band syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All runners from Sherbrooke available during the recruitment period will be invited to participate
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Concomitant affection of the hip or knee (ex: previous fracture or surgery of the knee)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment rate
Time frame: Through study completion, an average of 9 months
Proportion of included participants / total of contacts
Exclusion rate
Time frame: Through study completion, an average of 9 months
Proportion of excluded participants / total of contacts
Refusal rate
Time frame: Through study completion, an average of 9 months
Proportion of participants who refused to participate / total of contacts
Lenght of the procedure
Time frame: Baseline
Time for each evaluation in minutes
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
Acceptability of the procedure
Time frame: Baseline
opinion of participant regarding lenght of the procedure, unconfort or pain during the procedure
7 secondary outcomes
Morphometric ITB measures
Time frame: Baseline
Stiffness of ITB
Time frame: Baseline
Stiffness of TFL
Time frame: Baseline
Pain intensity
Time frame: Baseline
Knee pain and function questionnaires
Time frame: Baseline
Knee pain and function questionnaires
Time frame: Baseline
Muscle retraction test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: Undecided
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Recruiting
Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
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Recruiting
Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaly Gaudreault, Pt, Ph.D principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iliotibial Band Syndrome, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Through study completion, an average of 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.