CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 119 enrolled
Drug / intervention
Shock Wave Therapy +2 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/NCT02757664
NCT02757664N/ACompleted

Shock Wave Therapy, Associated to Eccentric Strengthening Versus Isolated Eccentric Strengthening for Treating Insertional Achilles Tendinopathy: Double Blinded Randomized Clinical Trial

Federal University of São Paulo·interventional·Posted May 2, 2016·Updated Jun 17, 2020

In Brief

A clinical study evaluating Shock Wave Therapy, Eccentric Exercises, and 1 other intervention for Achilles Tendinitis and Tendinopathy. Completed, enrolled 119 participants across 1 site.

Detailed Summary

Background: There is no consensus regarding the treatment of insertional tendinopathies. The good results of the eccentric training in the management of the non-insertional Achilles tendinopathy were not reproducible in the insertional disease. Shock wave therapy is described as an alternative to these patients. Hypothesis: The shock wave therapy allied to the eccentric strengthening protocol presents better results that the eccentric strengthening associated to placebo. Design: Double blinded (outcome assessor and patient) randomized clinical trial, with the use of placebo, in parallel groups. Materials and Methods: Nine-three patients with chronic insertional tendinopathy will be enrolled in a randomized trial. Participants will be divided in two groups, one containing the combination of shock wave and eccentric exercises as treatment and the other comprehending the exercises assembled to placebo. The assessment of outcomes will occur in 2, 4, 6, 12 and 24 weeks of the beginning of the study. Patients will be evaluated for pain, activity and function by the VISA-A (the Victorian Institute of Sport Assessment-Achilles \[VISA-A\] questionnaire).

Study Details

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

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2, 2016
Enrollment StartFeb 1, 2017
Primary CompletionApr 1, 2020
Study CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.2 years ago

Interventions

Shock Wave Therapydevice

Appliance of radial shock waves with the BLT600 equipment (BTL Medical Technologies - Canada), the intensity being 2000 to 3000 pulses, 7 to 10Hz of frequency, and 1,5 a 2,5Bar of intensity per application; Appliance on the first day of treatment (D0), repeated on the second week after the first intervention (2nd week) and four weeks after the first intervention (4th week).

Eccentric Exercisesother

12 weeks, starting on the same day of the first appliance. The patient will practice the exercises standing on tiptoes and will perform exercises of passive ankle extension (dorsiflexion), three series of 15 repetitions, with the knee stretched, and three series of 15 repetitions with the knee flexed by 20 degrees.

Placebodevice

Placing of the apparatus´ therapeutic head with the support that impedes the shock wave propagation directly on the appliance field; Appliance of radial shock waves with the BLT600 equipment (BTL Medical Technologies - Canada), the intensity being 2000 to 3000 pulses, 7 to 10Hz of frequency, and 1,5 a 2,5Bar of intensity per application; Appliance on the first day of treatment (D0), repeated on the second week after the first intervention (2nd week) and four weeks after the first intervention (4th week).