Ultrasound-Monitored Changes in Achilles Tendinopathy After Extracorporeal Shock Wave Therapy
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Prague, Tsjekkia
- University Hospital Motol and 2nd Faculty of Medicine, Charles University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.
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Sham-komparator: 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.
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Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Cross-sectional Area at the Place of Maximum Tendon Width
Tidsramme: Change of initial values at 3 weeks follow up after last application (8th week).
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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.
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Change of initial values at 3 weeks follow up after last application (8th week).
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Change in Maximum Pain in the Achilles Tendon Area
Tidsramme: Change in maximum pain in the timeframe of the last application (5th week)
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Measured by numeric rating scale in points.
The values can reach 0-10 points.
A higher score means worse pain.
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Change in maximum pain in the timeframe of the last application (5th week)
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Change in Maximum Pain in the Achilles Tendon Area (Follow up)
Tidsramme: Change in maximum pain at 3 weeks follow up after last application (8th week).
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Measured by numeric rating scale in points.
The values can reach 0-10 points.
A higher score means worse pain.
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Change in maximum pain at 3 weeks follow up after last application (8th week).
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Change of Ankle Dorsiflexion Range of Motion
Tidsramme: Change of initial values at 3 weeks follow up after last application (8th week).
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Measured using weight-bearing lunge test in cm.
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Change of initial values at 3 weeks follow up after last application (8th week).
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Hypoechogenic Areas
Tidsramme: Change of the echostructure at 3 weeks follow up after last application (8th week).
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Echostructure is evaluated visually by investigator using musculoskeletal ultrasound machine.
Patients who have a hypoechogenic areas in the tendon are counted.
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Change of the echostructure at 3 weeks follow up after last application (8th week).
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Number of Participants With Increased Thickness of Achilles Tendon
Tidsramme: Change of the tendon continuity at 3 weeks follow up after last application (8th week).
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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.
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Change of the tendon continuity at 3 weeks follow up after last application (8th week).
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Change in VISA-A Questionnaire Score
Tidsramme: Change of initial values at 3 weeks follow up after last application (8th week).
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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.
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Change of initial values at 3 weeks follow up after last application (8th week).
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Change in Single Leg Heel Rise Test
Tidsramme: Change of initial values at 3 weeks follow up after last application (8th week)
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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.
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Change of initial values at 3 weeks follow up after last application (8th week)
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Change in Single Leg Hop Test
Tidsramme: Change of initial values at 3 weeks follow up after last application (8th week).
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Patient performs as many hops on one leg as possible in 30 seconds or until first sign of pain in Achilles tendon area.
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Change of initial values at 3 weeks follow up after last application (8th week).
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Stanislav Machač, Mgr., Ph.D., University Hospital Motol and 2nd Faculty of Medicine, Charles University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EK- 1/21
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