Comparison of Alfredson and Silbernagel Protocol in Competitive Athletes With Achilles Tendinopathy

Pain, Chronic Clinical Trial

Official title:

Comparison of Alfredson Eccentric and Silbernagel Concentric-eccentric Therapeutical Protocol in Competitive Athletes With Chronic Achilles Tendinopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05659134
• Other study ID #: 254/21
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Chronic Pain
• Pain, Chronic
• Tendinopathy
• Tendon Injuries
• Tendon Thickening

Intervention

Other:
• Alfredson protocol
Alfredson eccentric therapeutical protocol.
• Silbernagel protocol
Silbernagel concentric-eccentric protocol.

Locations

Country	Name	City	State
Czechia	Faculty of Physical Education and Sport at Charles University	Prague	Prague 6

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (13)

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. — View 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. — View 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. — View Citation

Habets B, van Cingel REH, Backx FJG, Huisstede BMA. Alfredson versus Silbernagel exercise therapy in chronic midportion Achilles tendinopathy: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Jul 11;18(1):296. doi: 10.1186/s12891-017-1656-4. — View 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. — View Citation

Nadeau MJ, Desrochers A, Lamontagne M, Lariviere C, Gagnon DH. Quantitative ultrasound imaging of Achilles tendon integrity in symptomatic and asymptomatic individuals: reliability and minimal detectable change. J Foot Ankle Res. 2016 Aug 17;9:30. doi: 10.1186/s13047-016-0164-3. eCollection 2016. — View Citation

Schneebeli A, Falla D, Clijsen R, Barbero M. Myotonometry for the evaluation of Achilles tendon mechanical properties: a reliability and construct validity study. BMJ Open Sport Exerc Med. 2020 Feb 12;6(1):e000726. doi: 10.1136/bmjsem-2019-000726. eCollection 2020. — View Citation

Scott A, Squier K, Alfredson H, Bahr R, Cook JL, Coombes B, de Vos RJ, Fu SN, Grimaldi A, Lewis JS, Maffulli N, Magnusson SP, Malliaras P, Mc Auliffe S, Oei EHG, Purdam CR, Rees JD, Rio EK, Gravare Silbernagel K, Speed C, Weir A, Wolf JM, Akker-Scheek IVD, Vicenzino BT, Zwerver J. ICON 2019: International Scientific Tendinopathy Symposium Consensus: Clinical Terminology. Br J Sports Med. 2020 Mar;54(5):260-262. doi: 10.1136/bjsports-2019-100885. Epub 2019 Aug 9. No abstract available. — View 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. — View Citation

Sleeswijk Visser TSO, van der Vlist AC, van Oosterom RF, van Veldhoven P, Verhaar JAN, de Vos RJ. Impact of chronic Achilles tendinopathy on health-related quality of life, work performance, healthcare utilisation and costs. BMJ Open Sport Exerc Med. 2021 Mar 26;7(1):e001023. doi: 10.1136/bmjsem-2020-001023. eCollection 2021. — View Citation

van der Plas A, de Jonge S, de Vos RJ, van der Heide HJ, Verhaar JA, Weir A, Tol JL. A 5-year follow-up study of Alfredson's heel-drop exercise programme in chronic midportion Achilles tendinopathy. Br J Sports Med. 2012 Mar;46(3):214-8. doi: 10.1136/bjsports-2011-090035. Epub 2011 Nov 10. — View Citation

van der Vlist AC, Winters M, Weir A, Ardern CL, Welton NJ, Caldwell DM, Verhaar JAN, de Vos RJ. Which treatment is most effective for patients with Achilles tendinopathy? A living systematic review with network meta-analysis of 29 randomised controlled trials. Br J Sports Med. 2021 Mar;55(5):249-256. doi: 10.1136/bjsports-2019-101872. Epub 2020 Jun 10. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Victorian Institute of Sport Assessment - Achilles (VISA-A)	The VISA-A questionnaire is the most commonly used outcome in clinical trials of Achilles tendinopathy treatment with proven reliability and validity. It consists of eight questions covering pain, function, daily living and sports activities. The score ranges from 0-100 where 0 means disability (impairment of function and pain of Achilles tendon) and 100 represents no disability.	1 year
Secondary	Biomechanical properties - stiffness	Achilles tendon stiffness (N/m) is a measure of the biomechanical response of the Achilles tendon tissue. Stiffness was assessed by MyotonPro (Myoton AS), which has been shown as a valid and reliable measurement tool of Achilles tendon mechanical properties in the clinical setting.	6 weeks
Secondary	Structure - micromorphology	Fibre organisation analysis of PSFR (mmˆ-1).	6 weeks