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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 25, 2012
Last Update Posted: February 26, 2014
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.
Information provided by (Responsible Party):
September 13, 2012
September 25, 2012
February 26, 2014
April 2012
June 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01691716 on ClinicalTrials.gov Archive Site
  • Pain level at rest [VAS 0-10] [ Time Frame: 0, 6, 12 weeks ]
  • Pain level at exertion [VAS 0-10] [ Time Frame: 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
  • SF-36 v2 quality of life survey [ Time Frame: 0, 12 weeks ]
  • Patient satisfaction [ Time Frame: 6, 12 weeks ]
    Patient satisfaction will be evaluated using a subjective questionnaire.
Same as current
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The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy
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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Achilles Tendinopathy
  • 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)
  • Experimental: Tendoactive
    Tendoactive dosage: 3 capsules per day
    Intervention: Drug: Tendoactive
  • Active Comparator: Eccentric training
    Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
    Intervention: Behavioral: Eccentric training
  • 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
    • Behavioral: Eccentric training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP