Iliotibial Band SyndromeNCT02296151
Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners
A study testing Gluteus medius strengthening and iliotibial band stretches in people with Iliotibial Band Syndrome, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Iliotibial Band Syndrome
- What is being tested?
- Gluteus medius strengthening and iliotibial band stretches
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Iliotibial Band Syndrome
- Being tested
- Gluteus medius strengthening, iliotibial band stretches
- Medical subject headings
- Iliotibial Band Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluteus medius strengtheningOther
Hip abductor, gluteus medius strengthening
iliotibial band stretchesOther
Iliotibial band stretches
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Four iliotibial band stretches; to be completed 3 days per week. Receives: Other: iliotibial band stretches |
| Group B | Active comparator | Four conventional hip exercises (Hip abductor, gluteus medius strengthening); to be completed 3 days per week. Receives: Other: Gluteus medius strengthening |
| Group C | Experimental | 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. Receives: Other: Gluteus medius strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip dynamometer strength
Hip dynamometer strengthening will be measured biweekly for the 8-week period
Measured: 8-weeks
Secondary outcomes (2)
Y-balance test
The Y-balance test kit is designed to measure quality of movement and function in three different movement planes.
Measured: Measured pre and post 8-week study
Single leg mini squat
The single leg mini squat will be used to assess quality of movement.
Measured: Measured pre and post 8-week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Iliotibial Band SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janine SieuNarine-McKay, University of British Columbia
- Investigators
- Dr. Rick Celebrini, PhD, PT, Study chair, Chief sport officer- Fortius sport & healthDr. Michael Hunt, MSc MPT PhD, Study chair, Assistant Professor (UBC)- Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296151
- Sponsor's protocol ID
- H13-01816
- Status last verified
- Mar 2018
- First submitted
- 18 Nov 2014
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 3606371Beers 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.
PubMed 20145781Birnbaum 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.
PubMed 15378277Devan 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.
PubMed 15496997Fairclough 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.
PubMed 16533314Fredericson 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.
PubMed 10959926
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners.
- ClinicalTrials.gov ID
- NCT02296151
- Acronym / sponsor ID
- H13-01816
- Conditions
- Iliotibial Band Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Other: iliotibial band stretchesFour iliotibial band stretches; to be completed 3 days per week. |
| Group B | Active comparator | Other: Gluteus medius strengtheningFour conventional hip exercises (Hip abductor, gluteus medius strengthening); to be completed 3 days per week. |
| Group C | Experimental | Other: Gluteus medius strengtheningFour 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. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluteus medius strengtheningHip abductor, gluteus medius strengthening | Other | Group B, Group C |
| iliotibial band stretchesIliotibial band stretches | Other | Group A |
Primary outcome
Hip dynamometer strength
Time frame: 8-weeks
Hip dynamometer strengthening will be measured biweekly for the 8-week period
2 secondary outcomes
Y-balance test
Time frame: Measured pre and post 8-week study
Single leg mini squat
Time frame: Measured pre and post 8-week study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Results publication: PubMed 3606371Agre 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 publication: PubMed 20145781Beers 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 publication: PubMed 15378277Birnbaum 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 publication: PubMed 15496997Devan 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 publication: PubMed 16533314Fairclough 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 publication: PubMed 10959926Fredericson 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.
Related trials for Iliotibial Band Syndrome
Recruiting
Progressive Resistance Training for Adults With External Snapping Hip
External Snapping Hip, Coxa Saltans External
Not yet recruiting
Exercise Program for ITB Syndrome
Iliotibial Band Syndrome
Recruiting
Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
Iliotibial Band Syndrome
Recruiting
Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)
Greater Trochanteric Pain Syndrome
Recruiting
Autogenic Inhibition Versus Reciprocal Inhibition Muscle Energy Techniques in Iliotibial Band Syndrome
Iliotibial Band Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Rick Celebrini, PhD, PT study chair
Chief sport officer- Fortius sport & health
Dr. Michael Hunt, MSc MPT PhD study chair
Assistant Professor (UBC)- Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluteus medius strengthening and iliotibial band stretches in people with Iliotibial Band Syndrome, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip dynamometer strength (time frame: 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02296151, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.