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Completed

NCT Number: NCT01691716

The Efficacy of Tendoactive, Eccentric Training, and the 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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMI, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tendoactive

Drug

Food supplement containing mucopolysaccharides, type I collagen and vitamin C

eccentric training

Behavioral

Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bioiberica

Industry

Registry information

Official study title

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

Acronym: Tendoactive

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2012
Registry last updated
Feb 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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