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NCT Number: NCT07668011

Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Giza, Giza Governorate, 2356, Egypt

Location status: Recruiting

About this study

The Iliotibial Band Syndrome is a frequently occurring overuse condition among runners and active individuals that often leads to persistent lateral knee pain and reduced function. Although exercise, particularly hip abductor strengthening, is considered effective, the optimal rehabilitation approach remains unclear. Recent evidence suggests that combining Radial Extracorporeal Shockwave Therapy with exercise may improve pain and function more than exercise alone.Therefore, evaluating whether the combination of rESWT and exercise is more effective than exercise alone is clinically relevant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Standard ITBS Exercise Program

Other

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

Radial Extracorporeal Shockwave Therapy

Device

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

Sham Extracorporal Shockwave Therapy

Device

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

Primary outcomes

  1. Numerical Pain Rating Scale Score (NPRS)

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

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

Secondary outcomes

  1. Lower extremity Functional Scale (LEFS)

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

    to assess the functional status of lower extremities. It consists of 20 items, each item is scored according to its difficulty : from 0 (extreme difficulty) to 4 (no difficulty),with a maximum score of 80 ( full function).

  2. Hip muscle strength dynamometer testing

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

    Hip ABD , ADD , IR and ER strength will be measured. Each strength will be measured twice using a hand held dynamometer . The mean value of the two values will be calculated.

  3. Pain Pressure Threshold algometry testing (PPT)

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

    PPT is measured three times using algometry that applies a gradually increasing pressure over the lateral femoral condyle\\distal ITB region until PPT is reached. The average of the 3 measurements will be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad El Melhat, PhD

CONTACT

[email protected]

+20 11 12595022

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effectiveness of Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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