- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02296151
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
Completed
Conditions
Intervention / Treatment
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
-
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British Columbia
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Vancouver, British Columbia, Canada, V6E2J3
- Optimal Performance Clinic
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-
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:
- Female between the ages of 19-45 years;
- Have been diagnosed or been affected by ITBS (pain on the outside of the knee) for no less than 3 months;
- A distance runner averaging a minimum of 15 Km per week of road running;
Exclusion Criteria:
- Have previous history of knee surgery or knee trauma to the affected side;
- 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.
Sponsor
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.
General Publications
- Agre JC, Magness JL, Hull SZ, Wright KC, Baxter TL, Patterson R, Stradel L. Strength testing with a portable dynamometer: reliability for upper and lower extremities. Arch Phys Med Rehabil. 1987 Jul;68(7):454-8.
- Beers A, Ryan M, Kasubuchi Z, Fraser S, Taunton JE. Effects of Multi-modal Physiotherapy, Including Hip Abductor Strengthening, in Patients with Iliotibial Band Friction Syndrome. Physiother Can. 2008 Spring;60(2):180-8. doi: 10.3138/physio.60.2.180. Epub 2008 Oct 10.
- Birnbaum K, Siebert CH, Pandorf T, Schopphoff E, Prescher A, Niethard FU. Anatomical and biomechanical investigations of the iliotibial tract. Surg Radiol Anat. 2004 Dec;26(6):433-46. doi: 10.1007/s00276-004-0265-8.
- Devan MR, Pescatello LS, Faghri P, Anderson J. A Prospective Study of Overuse Knee Injuries Among Female Athletes With Muscle Imbalances and Structural Abnormalities. J Athl Train. 2004 Sep;39(3):263-267.
- Fairclough J, Hayashi K, Toumi H, Lyons K, Bydder G, Phillips N, Best TM, Benjamin M. The functional anatomy of the iliotibial band during flexion and extension of the knee: implications for understanding iliotibial band syndrome. J Anat. 2006 Mar;208(3):309-16. doi: 10.1111/j.1469-7580.2006.00531.x.
- Fredericson M, Cookingham CL, Chaudhari AM, Dowdell BC, Oestreicher N, Sahrmann SA. Hip abductor weakness in distance runners with iliotibial band syndrome. Clin J Sport Med. 2000 Jul;10(3):169-75. doi: 10.1097/00042752-200007000-00004.
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
Additional Relevant MeSH Terms
Other Study ID 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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