Exercise Program for ITB Syndrome

Not Applicable

Not yet recruiting

• Conditions: Iliotibial Band Syndrome
• Interventions: Behavioral: Individualized Exercise Program; Behavioral: Standard Physical Therapy

• Registration Number: NCT06269757
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Study Start: 2024-11-01
• Primary Completion: 2025-08-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized Exercise Program	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.
Standard Physical Therapy	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) Score	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.
Knee injury and Osteoarthritis Outcome Score Physical Short-Form (KOOS-PS) Score	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.