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

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

Interventional

Enrollment (Actual)

24

Phase

  • 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

    • 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

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
Intervention / Treatment
PLACEBO_COMPARATOR: Group A
Four iliotibial band stretches; to be completed 3 days per week.
Iliotibial band stretches
ACTIVE_COMPARATOR: Group B
Four conventional hip exercises (Hip abductor, gluteus medius strengthening); to be completed 3 days per week.
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.
Hip abductor, gluteus medius strengthening

What is the study measuring?

Primary Outcome Measures

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

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

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.

Investigators

  • 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.

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

January 1, 2015

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (ESTIMATE)

November 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 24, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

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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