Exercise Program for ITB Syndrome

NCT06269757 | Not Yet Recruiting

• 1 other identifier: 23-01514
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Iliotibial Band Syndrome

Outcome Measures

Primary Outcomes (2)

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

  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.

  Month 6

• Visual Analogue Scale (VAS) Score

  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.

  Month 6

Study Arms (2)

Individualized Exercise Program

EXPERIMENTAL

Patients with diagnosed ITB syndrome indicated for non-operative management who are assigned to an individualized exercise program. Duration of therapy will be approximately 3 months. Patients will be followed for 6 months to assess longitudinal outcomes.

Behavioral: Individualized Exercise Program

Standard Physical Therapy

ACTIVE COMPARATOR

Patients with diagnosed ITB syndrome indicated for non-operative management who are assigned to receive standard physical therapy. Duration of therapy will be approximately 3 months. Patients will be followed for 6 months to assess longitudinal outcomes.

Behavioral: Standard Physical Therapy

Interventions

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.

Individualized Exercise Program

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.

Standard Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Iliotibial Band Syndrome

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Cumulative Trauma Disorders; Sprains and Strains

Study Officials

• Guillem Gonzalez-Lomas, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samy Shelbaya

CONTACT

517-575-5522; Samy.Shelbaya@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share