Iliotibial Band SyndromeNCT07534605
Effects of Ultrasound Therapy in Iliotibial Band Syndrome
A study testing Exercise, Continious Ultrasound and Intermittant ultrasound in people with Iliotibial Band Syndrome, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Iliotibial Band Syndrome
- What is being tested?
- Exercise, Continious Ultrasound and Intermittant ultrasound
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 19 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof.Dr.Cemil Taşcıoğlu Şehir Hastanesi
Istanbul, Şişli, 34384
About this study
Official title: 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.
Read the 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.
- Conditions
- Iliotibial Band Syndrome
- Being tested
- Exercise, Continious Ultrasound, Intermittant ultrasound
- Keywords
- Iliotibial band syndrome, ultrasound, ITBS
- 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.
ExerciseBehavioural
Hip and knee strengthening, core muscle strengthening, and ITB stretching exercises were given in 15 sessions.
Continious UltrasoundDevice
2 W/cm² intensity, 1.5 MHz frequency, 7 minutes, 15 continuous ultrasound sessions.
Intermittant ultrasoundDevice
2 W/cm² intensity, 1.5 MHz frequency, 7 minutes per session, 15 pulsed ultrasound treatments.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Exercise and continious ultrasound | Experimental | Not described Receives: Behavioral: Exercise; Device: Continious Ultrasound |
| Exercise and intermittant ultrasound | Experimental | Not described Receives: Behavioral: Exercise; Device: Intermittant ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS and LEFS
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
Measured: Before treatment, at the end of treatment (after 15 sessions) , and 3 months after treatment.
Secondary outcomes (1)
SF-12 and ITB thickness
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.
Measured: Before treatment, at the end of treatment (after 15 sessions) , and 3 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start15 Jun 2025
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Karapınar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534605
- Sponsor's protocol ID
- İTBS
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant information will not be shared to protect privacy.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound Therapy in Patients With Iliotibial Band Syndrome
- ClinicalTrials.gov ID
- NCT07534605
- Acronym / sponsor ID
- İTBS
- Conditions
- Iliotibial Band Syndrome
- Keywords
- Iliotibial band syndrome, ultrasound, ITBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 16 Apr 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise |
| Exercise and continious ultrasound | Experimental | Behavioral: Exercise, Device: Continious Ultrasound |
| Exercise and intermittant ultrasound | Experimental | Behavioral: Exercise, Device: Intermittant ultrasound |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| ExerciseHip and knee strengthening, core muscle strengthening, and ITB stretching exercises were given in 15 sessions. | Behavioural | Exercise, Exercise and continious ultrasound, Exercise and intermittant ultrasound |
| Continious Ultrasound2 W/cm² intensity, 1.5 MHz frequency, 7 minutes, 15 continuous ultrasound sessions. | Device | Exercise and continious ultrasound |
| Intermittant ultrasound2 W/cm² intensity, 1.5 MHz frequency, 7 minutes per session, 15 pulsed ultrasound treatments. | Device | Exercise and intermittant ultrasound |
Primary outcome
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
1 secondary outcome
SF-12 and ITB thickness
Time frame: Before treatment, at the end of treatment (after 15 sessions) , and 3 months after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. Participant information will not be shared to protect privacy.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Continious Ultrasound and Intermittant ultrasound in people with Iliotibial Band Syndrome, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS and LEFS (time frame: Before treatment, at the end of treatment (after 15 sessions) , and 3 months after treatment.). 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 16 Apr 2026.