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

Achilles Tendinopathy Clinical Trial

— Tendoactive  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691716
• Other study ID #: PRJ-00014
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: February 25, 2014
• Start date: April 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2014
• Source: Bioiberica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

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)

Locations

Country	Name	City	State
Spain	CMI	Barcelona
Spain	CEARE	Esplugues de Llobregat	Barcelona
Spain	Clínica CEMTRO	Madrid
Spain	AMS - Centro de Ejercicio	Malaga
Spain	Centro de Medicina y Deporte	Toledo
Spain	Clínica Traumatológica	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Bioiberica

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in VISA-A score at 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	12 weeks	No
Secondary	Pain level at rest [VAS 0-10]		0, 6, 12 weeks	No
Secondary	Pain level at exertion [VAS 0-10]		0, 6, 12weeks	No
Secondary	Achilles transverse thickness by ultrasound	Ultrasound evaluation of Achilles tendon. Maximum thickness will be recorded in the midportion of the affected Achilles tendon	0, 6, 12 weeks	No
Secondary	SF-36 v2 quality of life survey		0, 12 weeks	No
Secondary	Patient satisfaction	Patient satisfaction will be evaluated using a subjective questionnaire.	6, 12 weeks	No