Exercise Program for ITB Syndrome

Patients with diagnosed iliotibial band (ITB) syndrome indicated for non-operative management will be randomized to individualized exercise program or standard physical therapy over the course of 3 months to determine any possible difference in clinical outcomes.

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Key information

Conditions

Iliotibial Band Syndrome Cumulative Trauma Disorders Knee Injuries Leg Injuries Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of ITB syndrome
Age 18-65
Ability to comply with a standardized physical therapy protocol
Willing and able to provide consent

Exclusion criteria

Patients at any increased risk of falls or at increased risk from harm due to falling, including issues with vertigo, osteoporosis, or a history of past falls
Patient otherwise deemed at increased risk from this investigational rehabilitation program by their referring surgeon or physical therapist
Patients who are pregnant

Treatment and study plan

Individualized Exercise Program

Behavioral

The individualized exercise program involves an initial 2D individual running evaluation designed for runners of all ages and abilities, to help improve performance and prevent injury. During the assessment patients receive a one-on-one evaluation with an exercise physiologist that includes:

Running analysis;
Training program review;
Strength and flexibility assessment;
Review of running video;
Personalized final report.

Standard physical therapy

Behavioral

Standard of care physical therapy for ITB band syndrome involves exercises designed to target structural weaknesses such as hip abductor weakness. Typical exercises include but are not limited to hip flexor stretches, side lying hip abduction, figure 4 bridges, lateral walks with exercise bands, and side planks.

Primary outcomes

Knee injury and Osteoarthritis Outcome Score Physical Short-Form (KOOS-PS) Score

Time frame: Month 6

The KOOS-PS4 contains seven items: rising from bed, putting on socks/stockings, rising from sitting, bending to floor, twisting/pivoting on your injured knee, kneeling and squatting. Participants indicate the degree of difficulty they face in performing the items, from "none" to "extreme." A final global score, from 0 (no problems) to 100 (extreme problems), is produced for the scale. Lower scores indicate greater physical function.
Visual Analogue Scale (VAS) Score

Time frame: Month 6

Pain is rated on a 10-point scale, from 0 (no pain) to 10 (worst possible pain). The total score is the response; lower scores indicate less pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Samy Shelbaya

CONTACT

[email protected]

517-575-5522

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Efficacy of an Individualized Exercise Program for Iliotibial Band Syndrome: A Randomized Controlled Study

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Feb 21, 2024
Registry last updated: Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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