- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534605
Effects of Ultrasound Therapy in Iliotibial Band Syndrome
April 10, 2026 updated by: Seda Karapınar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Effects of Ultrasound Therapy in Patients With Iliotibial Band Syndrome
The aim of this study is to investigate the effect of ultrasound (US) therapy, administered in different modes, on pain, functionality, quality of life and iliotibial band (ITB) thickness in patients with iliotibial band syndrome (ITBS).
The primary question of the study is: Is US therapy effective in reducing pain and improving functionality in ITBS?
The secondary question is: Is US therapy effective in ITBS in terms of quality of life and ITB thickness?
75 participants were assigned to the exercise, exercise plus continuous US and exercise plus intermittent US groups and received 15 treatment sessions.
Participants were assessed before treatment, at the end of treatment (after 15 sessions) and at 3 months post-treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to investigate the effects of ultrasound (US) therapy, administered in different modes, on pain, functionality and iliotibial band (ITB) thickness in patients with iliotibial band syndrome (ITBS).
Seventy-five volunteers presenting at the Physical Medicine and Rehabilitation Clinic with lateral knee pain and thigh pain were included in the study.
Patients aged between 45 and 60 years who met the inclusion and exclusion criteria and had been diagnosed with ITBS were enrolled in the study.
The patients were divided into three groups and received 15 treatment sessions.
Group 1 received exercise only, Group 2 received exercise plus continuous ultrasound, and Group 3 received exercise plus intermittent ultrasound treatment.
Patients' pain scores were assessed using the Visual Analogue Scale (VAS), lower limb functionality using the Lower Limb Functionality Scale (LEFS), and quality of life using the Short Form-12 (SF-12) questionnaire before treatment, after treatment, and at the 3-month post-treatment mark.
In patients diagnosed with ITBS,ITB thickness was measured ultrasonographically at the attachment point of the lateral femoral epicondyle in the lateral lying position with the knee flexed at 20-30 degrees.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Şişli
-
Istanbul, Şişli, Turkey (Türkiye), 34384
- Prof.Dr.Cemil Taşcıoğlu Şehir Hastanesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria: - Aged between 45 and 60 years -Patients diagnosed with ITBS using ITB trigger point palpation and the Noble compression test -Visual Analogue Scale (VAS) score ≥50 mm
Exclusion Criteria:
- History of lower limb surgery within the last six month- Body weight exceeding 120 kg- History of malignancy-Severe coxarthrosis-Severe osteoporosis-Stage 4 gonarthrosis-Lower limb surgey in the last 6 months-History of any neurological, vascular or infectious disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
|
Hip and knee strengthening, core muscle strengthening, and ITB stretching exercises were given in 15 sessions.
|
|
Experimental: Exercise and continious ultrasound
|
Hip and knee strengthening, core muscle strengthening, and ITB stretching exercises were given in 15 sessions.
2 W/cm² intensity, 1.5 MHz frequency, 7 minutes, 15 continuous ultrasound sessions.
|
|
Experimental: Exercise and intermittant ultrasound
|
Hip and knee strengthening, core muscle strengthening, and ITB stretching exercises were given in 15 sessions.
2 W/cm² intensity, 1.5 MHz frequency, 7 minutes per session, 15 pulsed ultrasound treatments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS and LEFS
Time Frame: Before treatment, at the end of treatment (after 15 sessions) , and 3 months after treatment.
|
Pain intensity was assessed using the VAS.
Patients were asked to mark their pain levels on a straight line ranging from 0 to 10 cm; 0 denoted no pain, whilst 10 denoted severe pain.Lower limb functional status was assessed using the LEFS scale.
The scale, consisting of a total of 20 items, was scored according to five numerical response categories ranging from 0 (extreme difficulty/unable to perform the activity) to 4 (no difficulty).
The total score was assessed on a scale of 0 to 80. Higher scores were associated with better functional status
|
Before treatment, at the end of treatment (after 15 sessions) , and 3 months after treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SF-12 and ITB thickness
Time Frame: Before treatment, at the end of treatment (after 15 sessions) , and 3 months after treatment.
|
General physical and mental health status was assessed using the Short Form-12 (SF-12), a 12-item version of the SF-36.
Higher scores were associated with a better quality of life.
The thickness of the ITB was assessed using an USG scanner.
|
Before treatment, at the end of treatment (after 15 sessions) , and 3 months after treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2025
Primary Completion (Actual)
November 19, 2025
Study Completion (Actual)
November 19, 2025
Study Registration Dates
First Submitted
March 30, 2026
First Submitted That Met QC Criteria
April 10, 2026
First Posted (Actual)
April 16, 2026
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- İTBS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Participant information will not be shared to protect privacy.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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