NCT05427110

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2022

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

June 13, 2022

Last Update Submit

May 15, 2023

Conditions

Keywords

Iliotibial band syndromeStiffnessSonoelastography

Outcome Measures

Primary Outcomes (6)

  • Recruitment rate

    Proportion of included participants / total of contacts

    Through study completion, an average of 9 months

  • Exclusion rate

    Proportion of excluded participants / total of contacts

    Through study completion, an average of 9 months

  • Refusal rate

    Proportion of participants who refused to participate / total of contacts

    Through study completion, an average of 9 months

  • Lenght of the procedure

    Time for each evaluation in minutes

    Baseline

  • Cost of the study

    Cost of the patients compensation, ultrasounds gel, staff, in Canadian dollars

    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

    Baseline

Secondary Outcomes (7)

  • Morphometric ITB measures

    Baseline

  • Stiffness of ITB

    Baseline

  • Stiffness of TFL

    Baseline

  • Pain intensity

    Baseline

  • Knee pain and function questionnaires

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

asymptomatic

Runners without iliotibial band syndrome

Iliotibial band syndrome

Runners with iliotibial band syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Concomitant affection of the hip or knee (ex: previous fracture or surgery of the knee)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonia Bédard

Sherbrooke, Quebec, J1H5N4, Canada

Location

MeSH Terms

Conditions

Iliotibial Band Syndrome

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesCumulative Trauma DisordersSprains and Strains

Study Officials

  • Nathaly Gaudreault, Pt, Ph.D

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher and Full Professor

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 22, 2022

Study Start

May 5, 2022

Primary Completion

September 23, 2022

Study Completion

September 23, 2022

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations