Clinical trial NCT05659134: Comparison of Alfredson and Silbernagel Protocol in Competitive Athletes With Achilles Tendinopathy
Official title: Comparison of Alfredson Eccentric and Silbernagel Concentric-eccentric Therapeutical Protocol in Competitive Athletes With Chronic Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Achilles Tendinopathy
Tendon Injuries
Tendon Thickening
Pain, Chronic
Keywords: Achilles tendinopathy
VISA-A
Ultrasound
Stiffness
Competitive athletes
Exercise therapy
Alfredson protocol
Silbernagel protocol
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 6-week randomized clinical trial (RCT) with a 46-week follow-up compared the effect of Alfredson and Silbernagel eccentric programs for the treatment of AT. The primary outcome was a change in the Victorian Institute of Sport Assessment - Achilles (VISA-A) scale from baseline to 12 months. The study was approved by the Ethics Committee of the Faculty of Physical Education and Sport, Charles University (Project number: 254/2021). All participants provided written informed consent before participation.


Eligibility criteria: Inclusion criteria:

* Athletes performing track and field, tennis or football at the competitive level
* Age 18 to 40 years
* Unilateral Achilles tendinopathy
* Pain lasting more than 2 months
* Diagnosis of Achilles tendinopathy established by pain on function at the Achilles region and ultrasound assessment (tendon thickening, swollen tendon) by one researcher
* Participants trained at least 3 times per week before the onset of Achilles tendinopathy
* Less than 3 months without training and less than 6 months from the last competition/match
* Wish to return to original sport level
* Willing to stop with other treatments 2 weeks before the start of the clinical trial

Exclusion criteria:

* Achilles tendon rupture in past
* Corticosteroid injection in Achilles tendon region in last 6 months
* Having other lower limb musculoskeletal injuries or surgery in the last 6 months (e.g., muscle rupture, bone fracture)
* Having a neurological, systemic or autoimmune disease (e.g., neuropathy, type 1 diabetes, rheumatoid arthritis)

Primary outcomes:
measure: Victorian Institute of Sport Assessment - Achilles (VISA-A)
timeFrame: 1 year
Secondary outcomes:
measure: Biomechanical properties - stiffness
timeFrame: 6 weeks
measure: Structure - micromorphology
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Faculty of Physical Education and Sport at Charles University
state: Prague 6
Study officials:
References:
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citation: Wang Y, Zhou H, Nie Z, Cui S. Prevalence of Achilles tendinopathy in physical exercise: A systematic review and meta-analysis. Sports Med Health Sci. 2022 Mar 28;4(3):152-159. doi: 10.1016/j.smhs.2022.03.003. eCollection 2022 Sep.
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citation: Silbernagel KG, Crossley KM. A Proposed Return-to-Sport Program for Patients With Midportion Achilles Tendinopathy: Rationale and Implementation. J Orthop Sports Phys Ther. 2015 Nov;45(11):876-86. doi: 10.2519/jospt.2015.5885. Epub 2015 Sep 21.
citation: Breda SJ, Oei EHG, Zwerver J, Visser E, Waarsing E, Krestin GP, de Vos RJ. Effectiveness of progressive tendon-loading exercise therapy in patients with patellar tendinopathy: a randomised clinical trial. Br J Sports Med. 2021 May;55(9):501-509. doi: 10.1136/bjsports-2020-103403. Epub 2020 Nov 20.
citation: Habets B, van Cingel REH, Backx FJG, van Elten HJ, Zuithoff P, Huisstede BMA. No Difference in Clinical Effects When Comparing Alfredson Eccentric and Silbernagel Combined Concentric-Eccentric Loading in Achilles Tendinopathy: A Randomized Controlled Trial. Orthop J Sports Med. 2021 Oct 27;9(10):23259671211031254. doi: 10.1177/23259671211031254. eCollection 2021 Oct.
citation: Gravare Silbernagel K, Malliaras P, de Vos RJ, Hanlon S, Molenaar M, Alfredson H, van den Akker-Scheek I, Antflick J, van Ark M, Farnqvist K, Haleem Z, Kaux JF, Kirwan P, Kumar B, Lewis T, Mallows A, Masci L, Morrissey D, Murphy M, Newsham-West R, Norris R, O'Neill S, Peers K, Sancho I, Seymore K, Vallance P, van der Vlist A, Vicenzino B. ICON 2020-International Scientific Tendinopathy Symposium Consensus: A Systematic Review of Outcome Measures Reported in Clinical Trials of Achilles Tendinopathy. Sports Med. 2022 Mar;52(3):613-641. doi: 10.1007/s40279-021-01588-6. Epub 2021 Nov 19.
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