Exercise Program for ITB Syndrome

NCT ID: NCT06269757

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Individualized Exercise Program

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Standard Physical Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillem Gonzalez-Lomas, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Central Contacts

Samy Shelbaya

Role: CONTACT

Samy.Shelbaya@nyulangone.org

517-575-5522

Other Identifiers

23-01514

Identifier Type: -

Identifier Source: org_study_id