Iliotibial Band SyndromeNCT06269757
Exercise Program for ITB Syndrome
A study testing Individualized Exercise Program and Standard Physical Therapy in people with Iliotibial Band Syndrome, run by NYU Langone Health.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Iliotibial Band Syndrome
- What is being tested?
- Individualized Exercise Program and Standard Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of ITB syndrome
- Age 18-65
- Ability to comply with a standardized physical therapy protocol
- Willing and able to provide consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Iliotibial Band Syndrome
- Being tested
- Individualized Exercise Program, Standard Physical Therapy
- Medical subject headings
- Iliotibial Band Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Exercise ProgramBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2027 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliotibial Band SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillem Gonzalez-Lomas, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269757
- Sponsor's protocol ID
- 23-01514
- Status last verified
- Aug 2026
- First submitted
- 14 Feb 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared outside of NYULH.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Individualized Exercise Program for Iliotibial Band Syndrome: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06269757
- Acronym / sponsor ID
- 23-01514
- Conditions
- Iliotibial Band Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Exercise Program | Experimental | Behavioral: Individualized Exercise ProgramPatients 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 | Active comparator | Behavioral: Standard Physical TherapyPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of ITB syndrome
- Age 18-65
- Ability to comply with a standardized physical therapy protocol
- Willing and able to provide consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Exercise ProgramThe 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. | Behavioural | Individualized Exercise Program |
| Standard Physical TherapyStandard 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. | Behavioural | Standard Physical Therapy |
Primary outcome
Knee injury and Osteoarthritis Outcome Score Physical Short-Form (KOOS-PS) Score
Time frame: 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.
Visual Analogue Scale (VAS) Score
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No. Data will not be shared outside of NYULH.
Related trials for Iliotibial Band Syndrome
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Progressive Resistance Training for Adults With External Snapping Hip
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Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
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Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)
Greater Trochanteric Pain Syndrome
Active, not recruiting
Neuromuscular Inhibition Technique on Iliotibial Band Friction Syndrome
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Autogenic Inhibition Versus Reciprocal Inhibition Muscle Energy Techniques in Iliotibial Band Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillem Gonzalez-Lomas, MD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Exercise Program and Standard Physical Therapy in people with Iliotibial Band Syndrome, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reginald Brewster (917-573-6239, Reginald.Brewster@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score Physical Short-Form (KOOS-PS) Score (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.