Exercise Program for ITB Syndrome

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Iliotibial Band Syndrome
• Intervention / Treatment: Behavioral: Individualized Exercise Program; Behavioral: Standard Physical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Buldo-Licciardi; Phone Number: (201)-618-7204; Email: Michael.buldo-licciardi@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualized Exercise Program; 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; 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.
Active Comparator: Standard Physical Therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Guillem Gonzalez-Lomas, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Estimated): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Disease; Cumulative Trauma Disorders; Sprains and Strains; Knee Injuries; Syndrome; Iliotibial Band Syndrome
• Other Study ID Numbers: 23-01514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared outside of NYULH.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No