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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01691716
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Achilles Tendinopathy Drug: Tendoactive Behavioral: Eccentric training

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study Comparing the Therapeutic Effect of Tendoactive®, Eccentric Training, and a Combination of Both as a Treatment of Achilles Tendinopathy
Study Start Date : April 2012
Primary Completion Date : June 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis
U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pain level at rest [VAS 0-10] [ Time Frame: 0, 6, 12 weeks ]
  2. Pain level at exertion [VAS 0-10] [ Time Frame: 0, 6, 12weeks ]
  3. 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

  4. SF-36 v2 quality of life survey [ Time Frame: 0, 12 weeks ]
  5. Patient satisfaction [ Time Frame: 6, 12 weeks ]
    Patient satisfaction will be evaluated using a subjective questionnaire.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691716


Locations
Spain
CEARE
Esplugues de Llobregat, Barcelona, Spain, 08950
CMI
Barcelona, Spain
Clínica CEMTRO
Madrid, Spain
AMS - Centro de Ejercicio
Malaga, Spain
Centro de Medicina y Deporte
Toledo, Spain
Clínica Traumatológica
Valladolid, Spain
Sponsors and Collaborators
Bioiberica
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bioiberica
ClinicalTrials.gov Identifier: NCT01691716     History of Changes
Other Study ID Numbers: PRJ-00014
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014

Keywords provided by Bioiberica:
Achilles tendinopathy
Tendoactive
Eccentric training

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries