NCT07534605

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 30, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

Iliotibial band syndromeultrasoundITBS

Outcome Measures

Primary Outcomes (1)

  • 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

    Before treatment, at the end of treatment (after 15 sessions) , and 3 months after treatment.

Secondary Outcomes (1)

  • SF-12 and ITB thickness

    Before treatment, at the end of treatment (after 15 sessions) , and 3 months after treatment.

Study Arms (3)

Exercise

EXPERIMENTAL
Behavioral: Exercise

Exercise and continious ultrasound

EXPERIMENTAL
Behavioral: ExerciseDevice: Continious Ultrasound

Exercise and intermittant ultrasound

EXPERIMENTAL
Behavioral: ExerciseDevice: Intermittant ultrasound

Interventions

ExerciseBEHAVIORAL

Hip and knee strengthening, core muscle strengthening, and ITB stretching exercises were given in 15 sessions.

ExerciseExercise and continious ultrasoundExercise and intermittant ultrasound

2 W/cm² intensity, 1.5 MHz frequency, 7 minutes, 15 continuous ultrasound sessions.

Exercise and continious ultrasound

2 W/cm² intensity, 1.5 MHz frequency, 7 minutes per session, 15 pulsed ultrasound treatments.

Exercise and intermittant ultrasound

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof.Dr.Cemil Taşcıoğlu Şehir Hastanesi

Istanbul, Şişli, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Iliotibial Band Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesCumulative Trauma DisordersSprains and Strains

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Doctor

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 16, 2026

Study Start

June 15, 2025

Primary Completion

November 19, 2025

Study Completion

November 19, 2025

Last Updated

April 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Participant information will not be shared to protect privacy.

Locations