Exercise Program for ITB Syndrome

Iliotibial Band Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269757
• Other study ID #: 23-01514
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Michael Buldo-Licciardi
• Phone: (201)-618-7204
• Email: Michael.buldo-licciardi[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Iliotibial Band Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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