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Ultrasound-Monitored Changes in Achilles Tendinopathy After Extracorporeal Shock Wave Therapy

25 juni 2021 bijgewerkt door: Stanislav Machač, Ph.D, University Hospital, Motol

The Ultrasound-Monitored Changes in Achilles Tendinopathy After Focused Extracorporeal Shock Wave Therapy - a Randomized Sham-Controlled Trial

This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.

Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the first week, there will be a clinical examination by a physiotherapist, an ultrasonographic examination, and the patient will complete a VISA-A questionnaire. At the end of the examination, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.

Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the initial session, there will be a clinical examination by a physiotherapist, which includes case history questions, measuring range of motion (measured by weight-bearing lunge test), functional loading tests (1-leg heel rise test, 1-leg hop test) and an ultrasonographic examination (tendon cross section area and width at the maximal tendon antero-posterior width place). In addition, the patient will complete a VISA-A questionnaire. At the end of the initial session, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

18

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.

Studie Locaties

  • Tsjechië
      • Prague, Tsjechië
        • University Hospital Motol and 2nd Faculty of Medicine, Charles University

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

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • the patient complains about Achilles tendon pain, which limits (at least partially) his quality of life during daily activities or sport, and this condition would be referred as a tendinopathy
  • the patient's other leg is asymptomatic
  • the patient is not aware of the symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
  • the patient has no previous experience with extracorporeal shockwave therapy treatment

Exclusion Criteria:

  • the patient has condition which is contraindication for extracorporeal shock wave therapy treatment
  • the patient had symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)

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: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment Group (A)
Group of patients with Achilles tendinopathy which are treated by focused extracorporeal shockwave therapy once a week for 5 weeks. ESWT parameters: 0,12 mJ/mm2, 10 Hz, 1300 shocks.
Apparaat: BTL-6000 FSWT
Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.
Sham-vergelijker: Sham Group (B)
Group of patients with Achilles tendinopathy in which sham extracorporeal shockwave therapy is applied once a week for 5 weeks. Total applications are 5, applicated weekly. Sham ESWT parameters are same as in Group A (0,12 mJ/mm2, 10 Hz, 1300 shocks) but with modified applicator which does not allow wave transmission.
Apparaat: BTL-6000 FSWT with sham applicator
Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Cross-sectional Area at the Place of Maximum Tendon Width
Tijdsspanne: Change of initial values at 3 weeks follow up after last application (8th week).
Measured by measuring tools in ultrasound machine in cm2. In linear view is selected maximal width place, then the position of ultrasound head is rotated to horizontal view and in this view cross section area is measured.
Change of initial values at 3 weeks follow up after last application (8th week).
Change in Maximum Pain in the Achilles Tendon Area
Tijdsspanne: Change in maximum pain in the timeframe of the last application (5th week)
Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.
Change in maximum pain in the timeframe of the last application (5th week)
Change in Maximum Pain in the Achilles Tendon Area (Follow up)
Tijdsspanne: Change in maximum pain at 3 weeks follow up after last application (8th week).
Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.
Change in maximum pain at 3 weeks follow up after last application (8th week).
Change of Ankle Dorsiflexion Range of Motion
Tijdsspanne: Change of initial values at 3 weeks follow up after last application (8th week).
Measured using weight-bearing lunge test in cm.
Change of initial values at 3 weeks follow up after last application (8th week).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Hypoechogenic Areas
Tijdsspanne: Change of the echostructure at 3 weeks follow up after last application (8th week).
Echostructure is evaluated visually by investigator using musculoskeletal ultrasound machine. Patients who have a hypoechogenic areas in the tendon are counted.
Change of the echostructure at 3 weeks follow up after last application (8th week).
Number of Participants With Increased Thickness of Achilles Tendon
Tijdsspanne: Change of the tendon continuity at 3 weeks follow up after last application (8th week).
The Achilles tendon continuity in evaluated visually by investigator using musculoskeletal ultrasound machine. Patients who have a visually significant increased thickness of tendon will be counted.
Change of the tendon continuity at 3 weeks follow up after last application (8th week).
Change in VISA-A Questionnaire Score
Tijdsspanne: Change of initial values at 3 weeks follow up after last application (8th week).
The VISA-A questionnaire is standardized questionnaire for patients with Achilles tendinopathy. The results are recorded in points (0-100 points). The higher score indicates patients better condition.
Change of initial values at 3 weeks follow up after last application (8th week).
Change in Single Leg Heel Rise Test
Tijdsspanne: Change of initial values at 3 weeks follow up after last application (8th week)
Patient performs as many heel rises using only one leg as possible in 30 seconds or until first sign of pain in Achilles tendon area.
Change of initial values at 3 weeks follow up after last application (8th week)
Change in Single Leg Hop Test
Tijdsspanne: Change of initial values at 3 weeks follow up after last application (8th week).
Patient performs as many hops on one leg as possible in 30 seconds or until first sign of pain in Achilles tendon area.
Change of initial values at 3 weeks follow up after last application (8th week).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Motol

Onderzoekers

  • Hoofdonderzoeker: Stanislav Machač, Mgr., Ph.D., University Hospital Motol and 2nd Faculty of Medicine, Charles University

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 (Werkelijk)

1 februari 2021

Primaire voltooiing (Werkelijk)

2 april 2021

Studie voltooiing (Werkelijk)

2 april 2021

Studieregistratiedata

Eerst ingediend

24 februari 2021

Eerst ingediend dat voldeed aan de QC-criteria

28 februari 2021

Eerst geplaatst (Werkelijk)

4 maart 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 juni 2021

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2021

Laatst geverifieerd

1 juni 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • EK- 1/21

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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