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
NCT number | NCT05427110 |
Other study ID # | 2022-4344 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 5, 2022 |
Est. completion date | September 23, 2022 |
Verified date | May 2023 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Canada | Sonia Bédard | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
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 |
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