Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners
Primary Purpose
Iliotibial Band Syndrome
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gluteus medius strengthening
iliotibial band stretches
Sponsored by
About this trial
This is an interventional treatment trial for Iliotibial Band Syndrome
Eligibility Criteria
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;
Sites / Locations
- Optimal Performance Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Group A
Group B
Group C
Arm Description
Four iliotibial band stretches; to be completed 3 days per week.
Four conventional hip exercises (Hip abductor, gluteus medius strengthening); to be completed 3 days per week.
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.
Outcomes
Primary Outcome Measures
Hip dynamometer strength
Hip dynamometer strengthening will be measured biweekly for the 8-week period
Secondary Outcome Measures
Y-balance test
The Y-balance test kit is designed to measure quality of movement and function in three different movement planes.
Single leg mini squat
The single leg mini squat will be used to assess quality of movement.
Full Information
NCT ID
NCT02296151
First Posted
November 18, 2014
Last Updated
March 24, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02296151
Brief Title
Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners
Official Title
Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iliotibial Band Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Placebo Comparator
Arm Description
Four iliotibial band stretches; to be completed 3 days per week.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Four conventional hip exercises (Hip abductor, gluteus medius strengthening); to be completed 3 days per week.
Arm Title
Group C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gluteus medius strengthening
Intervention Description
Hip abductor, gluteus medius strengthening
Intervention Type
Other
Intervention Name(s)
iliotibial band stretches
Intervention Description
Iliotibial band stretches
Primary Outcome Measure Information:
Title
Hip dynamometer strength
Description
Hip dynamometer strengthening will be measured biweekly for the 8-week period
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Y-balance test
Description
The Y-balance test kit is designed to measure quality of movement and function in three different movement planes.
Time Frame
Measured pre and post 8-week study
Title
Single leg mini squat
Description
The single leg mini squat will be used to assess quality of movement.
Time Frame
Measured pre and post 8-week study
Other Pre-specified Outcome Measures:
Title
Numeric pain scale
Description
This is subjective rating scale 0-10. Participants will rate their pain weekly.
Time Frame
Measured weekly for the duration of the 8-week study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Rick Celebrini, PhD, PT
Organizational Affiliation
Chief sport officer- Fortius sport & health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. Michael Hunt, MSc MPT PhD
Organizational Affiliation
Assistant Professor (UBC)- Department of Physical Therapy
Official's Role
Study Chair
Facility Information:
Facility Name
Optimal Performance Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E2J3
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
3606371
Citation
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.
Results Reference
result
PubMed Identifier
20145781
Citation
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.
Results Reference
result
PubMed Identifier
15378277
Citation
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.
Results Reference
result
PubMed Identifier
15496997
Citation
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.
Results Reference
result
PubMed Identifier
16533314
Citation
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.
Results Reference
result
PubMed Identifier
10959926
Citation
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.
Results Reference
result
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Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners
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