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

Bioiberica

Status: Completed

Conditions: Achilles Tendinopathy

Treatments: Behavioral: Eccentric training; Drug: Tendoactive

Study type: Interventional

Funder types: Industry

Identifiers

NCT01691716

PRJ-00014

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Tendoactive

Experimental group

Description:

Tendoactive dosage: 3 capsules per day

Treatment:

Drug: Tendoactive

Eccentric training

Active Comparator group

Description:

Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Treatment:

Behavioral: Eccentric training

Tendoactive and eccentric training

Active Comparator group

Description:

Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Treatment:

Behavioral: Eccentric training

Drug: Tendoactive