CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
BTL-6000 FSWT +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04780919
NCT04780919N/ACompleted

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

University Hospital, Motol·interventional·Posted Mar 4, 2021·Updated Jun 28, 2021

In Brief

A clinical study evaluating BTL-6000 FSWT and BTL-6000 FSWT with sham applicator for Achilles Tendinopathy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 4, 2021
Enrollment StartFeb 1, 2021
Primary CompletionApr 2, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.3 years ago

Interventions

BTL-6000 FSWTdevice

Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.

BTL-6000 FSWT with sham applicatordevice

Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission.