Clinical trial NCT01691716: The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendinopathy
Keywords: Achilles tendinopathy
Tendoactive
Eccentric training
Lead sponsor: Bioiberica
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in VISA-A score at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain level at rest [VAS 0-10]
timeFrame: 0, 6, 12 weeks
measure: Pain level at exertion [VAS 0-10]
timeFrame: 0, 6, 12weeks
measure: Achilles transverse thickness by ultrasound
timeFrame: 0, 6, 12 weeks
measure: SF-36 v2 quality of life survey
timeFrame: 0, 12 weeks
measure: Patient satisfaction
timeFrame: 6, 12 weeks
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: CEARE
state: Barcelona
city: Barcelona
country: Spain
facility: CMI
city: Madrid
country: Spain
facility: Clínica CEMTRO
city: Malaga
country: Spain
facility: AMS - Centro de Ejercicio
city: Toledo
country: Spain
facility: Centro de Medicina y Deporte
city: Valladolid
country: Spain
facility: Clínica Traumatológica
Study officials:
References:
citation: Alfredson H, Pietila 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. doi: 10.1177/03635465980260030301.
citation: Balius R, Alvarez G, Baro F, Jimenez F, Pedret C, Costa E, Martinez-Puig D. A 3-Arm Randomized Trial for Achilles Tendinopathy: Eccentric Training, Eccentric Training Plus a Dietary Supplement Containing Mucopolysaccharides, or Passive Stretching Plus a Dietary Supplement Containing Mucopolysaccharides. Curr Ther Res Clin Exp. 2016 Nov 18;78:1-7. doi: 10.1016/j.curtheres.2016.11.001. eCollection 2016.