Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome

NCT07668011 | Recruiting DMC

• 1 other identifier: rESWT and exercises in ITBS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this Clinical Trial Study is to evaluate the clinical effectiveness of Radial Electrocorporeal Shockwave Therapy (rESWT) combined with exercise in individuals with iliotibial band syndrome (ITBS).The main question it aims to answer is : Does the addition of rESWT to standard ITBS exercise program reduce pain intensity and pain pressure threshold while improving lower extremity function and hip muscle strength in Individuals with Iliotibial Band syndrome (ITBS). Participants will be divided into two groups to be compared : The ShamTherapy Group (Control Group) that will receive the standard ITBS exercise program in addition to Sham rESWT, while the experimental group will receive the standard ITBS exercise program in addition to Radial Extracorporeal Shockwave Therapy.

Conditions

Iliotibial Band Syndrome

Keywords

Iliotibial Band Syndrome; ITBS; ESWT; rESWT; Extracorporeal Shockwave Therapy; Radial Extracorporeal Shockwave Therapy

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Rating Scale Score (NPRS)

  To assess lateral knee pain intensity at rest and during activity Scores range from 0 (no pain) to 10 (worst pain)

  baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.

Secondary Outcomes (3)

• Lower extremity Functional Scale (LEFS)

  baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.

• Hip muscle strength dynamometer testing

  baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.

• Pain Pressure Threshold algometry testing (PPT)

  baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.

Study Arms (2)

Sham rESWT and Standard ITBS Exercise Program

ACTIVE COMPARATOR

This group will receive Sham rESWT and standard ITBS Exercise Program that will include ITB stretching and strengthening exercises mainly targeting hip abductors, hip external rotators and knee extensors.

Other: Standard ITBS Exercise Program; Device: Sham Extracorporal Shockwave Therapy

rESWT combined with exercise program

EXPERIMENTAL

The experimental group will receive the same standard exercise program in addition to rESWT on the distal portion of the ITB and the region of lateral femoral condyle.

Other: Standard ITBS Exercise Program; Device: Radial Extracorporeal Shockwave Therapy

Interventions

Standard ITBS Exercise Program OTHER

Standard ITBS Exercise Program : Flexibility and Strengthening Exercises will be delivered three times weekly over a 4-week period

Sham rESWT and Standard ITBS Exercise Program; rESWT combined with exercise program

Radial Extracorporeal Shockwave Therapy DEVICE

Radial Extracorporeal Shockwave Therapy will be delivered once weekly for 4 weeks only.

rESWT combined with exercise program

Sham Extracorporal Shockwave Therapy DEVICE

Sham Extracorporal Shockwave therapy will be administered once a week for 4 weeks.

Sham rESWT and Standard ITBS Exercise Program

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physically active individuals aged 18 and 45 years
• Have a clinical diagnosis of iliotibial band syndrome (ITBS) confirmed by physician within the previous four weeks.
• Report lateral knee pain during running or other functional activities
• No history of direct trauma
• Have a positive Noble compression or/and Ober test.

You may not qualify if:

• History of knee surgery,fracture , meniscal or ligamentous injury within the past year
• Any fracture involving the lower extremity within the previous six months
• Neurological disorders
• Lumbar radiculopathy
• Systemic inflammatory disease
• Any medical condition affecting gat or lower extremity function.
• Have received corticosteroid injection, shockwave therapy, or physical therapy treatment for ITBS within the previous six months
• Use of NDAID's or analgesics later than 2 weeks
• Individuals with contraindications to ESWT, including pregnancy, bleeding disorders, or use of anticoagulant medication.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Giza, Giza Governorate, 2356, Egypt

RECRUITING

Related Publications (3)

• Weckstrom K, Soderstrom J. Radial extracorporeal shockwave therapy compared with manual therapy in runners with iliotibial band syndrome. J Back Musculoskelet Rehabil. 2016;29(1):161-70. doi: 10.3233/BMR-150612.

  PMID: 26406193 BACKGROUND

• McKay J, Maffulli N, Aicale R, Taunton J. Iliotibial band syndrome rehabilitation in female runners: a pilot randomized study. J Orthop Surg Res. 2020 May 24;15(1):188. doi: 10.1186/s13018-020-01713-7.

  PMID: 32448384 BACKGROUND

• Geisler PR. Current Clinical Concepts: Synthesizing the Available Evidence for Improved Clinical Outcomes in Iliotibial Band Impingement Syndrome. J Athl Train. 2021 Aug 1;56(8):805-815. doi: 10.4085/1062-6050-548-19. Epub 2020 Dec 22.

  PMID: 34375405 BACKGROUND

MeSH Terms

Conditions

Iliotibial Band Syndrome

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Cumulative Trauma Disorders; Sprains and Strains

Study Officials

• Ahmed El Melhat, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad El Melhat, PhD

CONTACT

+20 11 12595022; ahmed.elmelhat@cu.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of MSK Physical Therapy at Cairo University.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)