The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy (Tendoactive)

February 25, 2014 updated by: Bioiberica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • CMI
      • Madrid, Spain
        • Clinica Cemtro
      • Malaga, Spain
        • AMS - Centro de Ejercicio
      • Toledo, Spain
        • Centro de Medicina y Deporte
      • Valladolid, Spain
        • Clínica Traumatológica
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • CEARE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).
  • Men and non-pregnant women aged 18-70 years
  • Be informed of the nature of the study and provide written informed consent.

Exclusion Criteria:

  • Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
  • Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap")
  • Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance)
  • Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve)
  • Clinical suspicion of peroneal subluxation
  • Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis.
  • Condition that prevents the patients from executing an active exercise programme
  • Patient has already performed eccentric exercises, according to the schedule of Alfredson et al (12 weeks)
  • Patient has already received an injection of PRP for this injury
  • Patient does not wish, for whatever reason, to undergo one of the two treatments
  • Known presence of a pregnancy
  • Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tendoactive
Tendoactive dosage: 3 capsules per day
Drug: Tendoactive
Food supplement containing mucopolysaccharides, type I collagen and vitamin C
Active Comparator: Eccentric training
Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
Behavioral: Eccentric training
Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
Active Comparator: Tendoactive and eccentric training
Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
Drug: Tendoactive
Food supplement containing mucopolysaccharides, type I collagen and vitamin C
Behavioral: Eccentric training
Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in VISA-A score at 12 weeks
Time Frame: 12 weeks
Functional impairment of the Achilles tendon is measured using VISA-A score. Score of patient-related outcome measure: Achilles tendon: VISA-A [0=worse, 100=perfect] derived from eight validated questions on pain and function during activities of daily living
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level at rest [VAS 0-10]
Time Frame: 0, 6, 12 weeks
0, 6, 12 weeks
Pain level at exertion [VAS 0-10]
Time Frame: 0, 6, 12weeks
0, 6, 12weeks
Achilles transverse thickness by ultrasound
Time Frame: 0, 6, 12 weeks
Ultrasound evaluation of Achilles tendon. Maximum thickness will be recorded in the midportion of the affected Achilles tendon
0, 6, 12 weeks
SF-36 v2 quality of life survey
Time Frame: 0, 12 weeks
0, 12 weeks
Patient satisfaction
Time Frame: 6, 12 weeks
Patient satisfaction will be evaluated using a subjective questionnaire.
6, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioiberica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Estimate)

February 26, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRJ-00014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Achilles Tendinopathy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe