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Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome

19. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
    • Giza Governorate
      • Giza, Giza Governorate, Egypten, 2356
        • Rekruttering
        • Cairo university hospitals

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Andet: Standard ITBS Exercise Program
Standard ITBS Exercise Program : Flexibility and Strengthening Exercises will be delivered three times weekly over a 4-week period
Enhed: Sham Extracorporal Shockwave Therapy
Sham Extracorporal Shockwave therapy will be administered once a week for 4 weeks.
Eksperimentel: 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.
Andet: Standard ITBS Exercise Program
Standard ITBS Exercise Program : Flexibility and Strengthening Exercises will be delivered three times weekly over a 4-week period
Enhed: Radial Extracorporeal Shockwave Therapy
Radial Extracorporeal Shockwave Therapy will be delivered once weekly for 4 weeks only.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Numerical Pain Rating Scale Score (NPRS)
Tidsramme: 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)
baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lower extremity Functional Scale (LEFS)
Tidsramme: 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).
baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
Hip muscle strength dynamometer testing
Tidsramme: 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.
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)
Tidsramme: 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.
baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Efterforskere

  • Ledende efterforsker: Ahmed El Melhat, PhD, Cairo University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. juni 2026

Primær færdiggørelse (Anslået)

10. august 2026

Studieafslutning (Anslået)

30. august 2026

Datoer for studieregistrering

Først indsendt

19. juni 2026

Først indsendt, der opfyldte QC-kriterier

19. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • rESWT and exercises in ITBS

Plan for individuelle deltagerdata (IPD)

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