Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
19 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ahmad El Melhat, PhD
- Telefoonnummer: +20 11 12595022
- E-mail: ahmed.elmelhat@cu.edu.lb
Studie Locaties
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Giza Governorate
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Giza, Giza Governorate, Egypte, 2356
- Werving
- Cairo university hospitals
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Numerical Pain Rating Scale Score (NPRS)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Lower extremity Functional Scale (LEFS)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ahmed El Melhat, PhD, Cairo University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
10 juni 2026
Primaire voltooiing (Geschat)
10 augustus 2026
Studie voltooiing (Geschat)
30 augustus 2026
Studieregistratiedata
Eerst ingediend
19 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
19 juni 2026
Eerst geplaatst (Werkelijk)
25 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
19 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- rESWT and exercises in ITBS
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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