The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy
- Conditions
- Achilles Tendinopathy
- Interventions
- Drug: TendoactiveBehavioral: Eccentric training
- Registration Number
- NCT01691716
- Lead Sponsor
- Bioiberica
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tendoactive Tendoactive Tendoactive dosage: 3 capsules per day Eccentric training Eccentric training Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360) Tendoactive and eccentric training Tendoactive Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360) Tendoactive and eccentric training Eccentric training Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (6)
AMS - Centro de Ejercicio
🇪🇸Malaga, Spain
CEARE
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Centro de Medicina y Deporte
🇪🇸Toledo, Spain
Clínica Traumatológica
🇪🇸Valladolid, Spain
Clínica CEMTRO
🇪🇸Madrid, Spain
CMI
🇪🇸Barcelona, Spain