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

NCT04780919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-06-28

Study results available
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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.

Conditions

  • Achilles Tendinopathy

Interventions

DEVICE

BTL-6000 FSWT

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

DEVICE

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.

Sponsors & Collaborators

  • University Hospital, Motol

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-04-02
Completion
2021-04-02

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780919 on ClinicalTrials.gov