Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners

March 24, 2018 updated by: Janine SieuNarine-McKay, University of British Columbia

Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners.

The primary objective of this study is to determine if a more specific exercise routine that incorporates a progressive hip stability program will help to rehabilitate the hip and reduce symptoms of iliotibial band syndrome more than conventional hip exercises. Three different exercises interventions will be compared to determine its effectiveness in reducing pain, improving function and returning subjects to running symptom free. Secondary objective for this study is to establish an intervention program for female runners with this injury. There will be three treatment arms and participants will be randomly assigned to one of three groups: Group A- control (stretching), group B (conventional hip exercises and group C (experimental treatment- specific progressive hip exercises).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The gluteus medius muscle is part of a muscle group called the hip abductor muscles. The gluteus medius originates at the dorsal ilium (uppermost, largest bone of the pelvis) below the iliac crest and inserts at the top outside surfaces of the greater trochanter (top of the thigh bone). It is the major abductor of the thigh (moves the leg away from the midline of the body). The anterior fibres rotate the hip internally and the posterior fibres rotate the hip externally. Based on the anatomy and function of this muscle, the gluteus medius plays a major role in the mechanics of running. Research has shown that runners with iliotibial band syndrome have been shown to have weakness in this muscle. Most conventional exercises that have been research have been exercises that focus on only activation of this muscle in an unloaded position (non-weightbearing). Group B of this study will focus on those exercises that have been researched. Group C will be the experimental group in which we will begin with the conventional exercises and progress the exercises from a floor (unloaded) position to a more dynamic functional position (standing). This will be geared towards running specific exercises. We would like to know if there will be a difference in how fast symptoms reduce and strength gains occur and at what rate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E2J3
        • Optimal Performance Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female between the ages of 19-45 years;
  2. Have been diagnosed or been affected by ITBS (pain on the outside of the knee) for no less than 3 months;
  3. A distance runner averaging a minimum of 15 Km per week of road running;

Exclusion Criteria:

  1. Have previous history of knee surgery or knee trauma to the affected side;
  2. Have been diagnosed with any other knee pathology such as patellofemoral pain syndrome, degenerative joint disease, chondromalacia patella, tendinitis or tendinopathy in the affected 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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Group A
Four iliotibial band stretches; to be completed 3 days per week.
Other: iliotibial band stretches
Iliotibial band stretches
ACTIVE_COMPARATOR: Group B
Four conventional hip exercises (Hip abductor, gluteus medius strengthening); to be completed 3 days per week.
Other: Gluteus medius strengthening
Hip abductor, gluteus medius strengthening
EXPERIMENTAL: Group C
Four conventional hip exercises progressed during the 8-weeks, totalling 16 exercises over the 8-week period (Hip abductor, gluteus medius strengthening). Exercises to be completed 3 days per week.
Other: Gluteus medius strengthening
Hip abductor, gluteus medius strengthening

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hip dynamometer strength
Time Frame: 8-weeks
Hip dynamometer strengthening will be measured biweekly for the 8-week period
8-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Y-balance test
Time Frame: Measured pre and post 8-week study
The Y-balance test kit is designed to measure quality of movement and function in three different movement planes.
Measured pre and post 8-week study
Single leg mini squat
Time Frame: Measured pre and post 8-week study
The single leg mini squat will be used to assess quality of movement.
Measured pre and post 8-week study

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numeric pain scale
Time Frame: Measured weekly for the duration of the 8-week study
This is subjective rating scale 0-10. Participants will rate their pain weekly.
Measured weekly for the duration of the 8-week study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dr. Rick Celebrini, PhD, PT, Chief sport officer- Fortius sport & health
  • Study Chair: Dr. Michael Hunt, MSc MPT PhD, Assistant Professor (UBC)- Department of Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H13-01816

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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