Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioiberica
ClinicalTrials.gov Identifier:
NCT01691716
First received: September 13, 2012
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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 Intervention
Achilles Tendinopathy
Drug: Tendoactive
Behavioral: Eccentric training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bioiberica:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: April 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Bioiberica
ClinicalTrials.gov Identifier: NCT01691716     History of Changes
Other Study ID Numbers: PRJ-00014
Study First Received: September 13, 2012
Last Updated: February 25, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by Bioiberica:
Achilles tendinopathy
Tendoactive
Eccentric training

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

ClinicalTrials.gov processed this record on November 27, 2014