Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
19 de junio de 2026 actualizado por: Ahmed ElMelhat, Cairo University
Effectiveness of 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ahmad El Melhat, PhD
- Número de teléfono: +20 11 12595022
- Correo electrónico: ahmed.elmelhat@cu.edu.lb
Ubicaciones de estudio
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Giza Governorate
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Giza, Giza Governorate, Egipto, 2356
- Reclutamiento
- Cairo university hospitals
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Sham rESWT and Standard ITBS Exercise Program
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.
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Standard ITBS Exercise Program : Flexibility and Strengthening Exercises will be delivered three times weekly over a 4-week period
Sham Extracorporal Shockwave therapy will be administered once a week for 4 weeks.
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Experimental: rESWT combined with exercise program
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.
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Standard ITBS Exercise Program : Flexibility and Strengthening Exercises will be delivered three times weekly over a 4-week period
Radial Extracorporeal Shockwave Therapy will be delivered once weekly for 4 weeks only.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Numerical Pain Rating Scale Score (NPRS)
Periodo de tiempo: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
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To assess lateral knee pain intensity at rest and during activity Scores range from 0 (no pain) to 10 (worst pain)
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baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Lower extremity Functional Scale (LEFS)
Periodo de tiempo: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
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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).
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baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
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Hip muscle strength dynamometer testing
Periodo de tiempo: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
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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.
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baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
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Pain Pressure Threshold algometry testing (PPT)
Periodo de tiempo: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
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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.
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baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ahmed El Melhat, PhD, Cairo University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
10 de junio de 2026
Finalización primaria (Estimado)
10 de agosto de 2026
Finalización del estudio (Estimado)
30 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
19 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de junio de 2026
Publicado por primera vez (Actual)
25 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- rESWT and exercises in ITBS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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