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

Study Overview
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Brief Summary
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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.

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

Conditions
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Achilles Tendinopathy

Intervention / Treatment
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* Drug: Tendoactive
* Behavioral: Eccentric training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tendoactive<br>Tendoactive dosage: 3 capsules per day | Drug: Tendoactive<br>* Food supplement containing mucopolysaccharides, type I collagen and vitamin C<br>|
| Active Comparator: Eccentric training<br>Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360) | Behavioral: Eccentric training<br>* Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)<br>|
| Active Comparator: Tendoactive and eccentric training<br>Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360) | Drug: Tendoactive<br>* Food supplement containing mucopolysaccharides, type I collagen and vitamin C<br>Behavioral: Eccentric training<br>* Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level at rest [VAS 0-10] |  | 0, 6, 12 weeks | 
| Pain level at exertion [VAS 0-10] |  | 0, 6, 12weeks | 
| 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 | 
| SF-36 v2 quality of life survey |  | 0, 12 weeks | 
| Patient satisfaction | Patient satisfaction will be evaluated using a subjective questionnaire. | 6, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achilles tendinopathy, Tendoactive, Eccentric training