NCT02296151

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

November 18, 2014

Last Update Submit

March 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hip dynamometer strength

    Hip dynamometer strengthening will be measured biweekly for the 8-week period

    8-weeks

Secondary Outcomes (2)

  • Y-balance test

    Measured pre and post 8-week study

  • Single leg mini squat

    Measured pre and post 8-week study

Other Outcomes (1)

  • Numeric pain scale

    Measured weekly for the duration of the 8-week study

Study Arms (3)

Group A

PLACEBO COMPARATOR

Four iliotibial band stretches; to be completed 3 days per week.

Other: iliotibial band stretches

Group B

ACTIVE COMPARATOR

Four conventional hip exercises (Hip abductor, gluteus medius strengthening); to be completed 3 days per week.

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.

Other: Gluteus medius strengthening

Interventions

Hip abductor, gluteus medius strengthening

Group BGroup C

Iliotibial band stretches

Group A

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optimal Performance Clinic

Vancouver, British Columbia, V6E2J3, Canada

Location

Related Publications (6)

  • 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.

MeSH Terms

Conditions

Iliotibial Band Syndrome

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesCumulative Trauma DisordersSprains and Strains

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Janine McKay

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

January 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations