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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2023
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Sonia Bédard Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

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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