Completed

TendoactiveA Prospective Randomized Study Comparing the Therapeutic Effect of Tendoactive®, Eccentric Training, and a Combination of Both as a Treatment of Achilles Tendinopathy

What is being tested

Tendoactive

+ Eccentric training

+ Tendoactive

DrugBehavioral

Who is being recruted

From 18 to 70 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: April 2012

See protocol details

Summary

Principal SponsorBioiberica

Last updated: February 26, 2014

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2012

Actual date on which the first participant was enrolled.

The purpose of this study is to determine whether Tendoactive, eccentric training, or the combination or both could be effective in the treatment of Achilles tendinopathy.

NCT01691716

Principal SponsorBioiberica

Last updated: February 26, 2014

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

Be informed of the nature of the study and provide written informed consent

Men and non-pregnant women aged 18-70 years

Patients suffering from a gradually evolving painful condition in the Achilles tendon located at the midportion for at least 3 months (Diagnosis based on clinical examination showing a painful thickening of the Achilles tendon located at a level of 2 to 6cm above the tendon insertion, and confirmed by ultrasonography: local thickening of the tendon, irregular tendon structure with hypoechoic areas and irregular fiber orientation)

12 exclusion criteria prevent from participating

Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap")

Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)

Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve)

Clinical suspicion of peroneal subluxation

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Tendoactive dosage: 3 capsules per day

Group II

Active Comparator

Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Group III

Active Comparator

Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

CMI

Barcelona, SpainOpen CMI in Google Maps

CEARE

Esplugues de Llobregat, Spain

Clínica CEMTRO

Madrid, Spain

AMS - Centro de Ejercicio

Málaga, Spain

Completed6 Study Centers