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

This study is currently recruiting participants.
Verified September 2012 by Bioiberica
Sponsor:
Information provided by (Responsible Party):
Bioiberica
ClinicalTrials.gov Identifier:
NCT01691716
First received: September 13, 2012
Last updated: September 21, 2012
Last verified: September 2012
History of Changes

September 13, 2012
September 21, 2012
April 2012
March 2013   (final data collection date for primary outcome measure)
Change from Baseline in VISA-A score at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Pain level at exertion [VAS 0-10] [ Time Frame: 0, 6, 12weeks ] [ Designated as safety issue: No ]
  • Achilles transverse thickness by ultrasound [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 6, 12 weeks ] [ Designated as safety issue: No ]
    Patient satisfaction will be evaluated using a subjective questionnaire.
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)
    Interventions:
    • Drug: Tendoactive
    • Behavioral: Eccentric training
Alfredson H, Pietilä T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
March 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
Both
18 Years to 70 Years
No
Contact: Ramon Balius, MD +34 93 4804900 rbalius@gencat.cat
Spain
 
NCT01691716
PRJ-00014
Not Provided
Bioiberica
Bioiberica
Not Provided
Not Provided
Bioiberica
September 2012

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