Achilles Tendinopathy
Conditions
Keywords
Achilles tendinopathy, Tendoactive, Eccentric training
Brief 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.
Interventions
DRUGTendoactive
Food supplement containing mucopolysaccharides, type I collagen and vitamin C
BEHAVIORALEccentric training
Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
Sponsors
Bioiberica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in VISA-A score at 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 0, 6, 12 weeks | 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 | 0, 12 weeks | — |
| Patient satisfaction | 6, 12 weeks | Patient satisfaction will be evaluated using a subjective questionnaire. |
Countries
Spain
Outcome results
None listed