Back to resultsComparison of Alfredson and Silbernagel Protocol in Competitive Athletes With Achilles Tendinopathy
Primary Purpose
Achilles Tendinopathy, Tendon Injuries, Tendon Thickening
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Alfredson protocol
Silbernagel protocol
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendinopathy focused on measuring Achilles tendinopathy, VISA-A, Ultrasound, Stiffness, Competitive athletes, Exercise therapy, Alfredson protocol, Silbernagel protocol
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)
Sites / Locations
- Faculty of Physical Education and Sport at Charles UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Alfredson group (A)
Silbernagel group (B)
Arm Description
Participants allocated to the Alfredson exercise program were instructed to exercise twice a day on both legs for 12 months. They performed concentric calf rises (CR) on both legs up and eccentric CR on one leg down. The protocol contained 15 repetitions and 3 sets on each leg with extended and flexed knee. One session contained 45 reps in the flexed position and 45 reps in the extended position, the total daily number of reps was 180. At the start, the exercises were performed with body weight. Participants could progress by adding the 5, 10 and 15 kg, if they met the criteria. The criteria for adding weight was at least one week of training at the same weight and no disabling pain during or after the exercise during the week.
Participants allocated to the Silbernagel exercise program were instructed to exercise every day with exception of the first week (every other day) for 12 months. The protocol contained 4 phases, which were based on a variety of CR exercises. The protocol contained concentric and eccentric CR on both legs, CR on one leg, CR in sitting, CR on the step, CR without step, quick rebound CR, CR with added weight and hops on the forefoot. The daily number of reps for 1st phase was 135, for the 2nd phase was 240, for the 3rd phase was 255 and for the 4th phase was 150. It's performed with body weight, added weight and plyometric loading progressively through all phases (maximal added weight is 15 kilos). To progress to the next phase participant needs to reach pain intensity during and after exercise under 5 from the 10 on the visual analogue scale, morning stiffness should not increase as well as pain during the week.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Structure - micromorphology
Fibre organisation analysis of PSFR (mmˆ-1).
Full Information
NCT ID
NCT05659134
First Posted
November 14, 2022
Last Updated
December 12, 2022
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT05659134
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy, Tendon Injuries, Tendon Thickening, Pain, Chronic
Keywords
Achilles tendinopathy, VISA-A, Ultrasound, Stiffness, Competitive athletes, Exercise therapy, Alfredson protocol, Silbernagel protocol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alfredson group (A)
Arm Type
Active Comparator
Arm Description
Participants allocated to the Alfredson exercise program were instructed to exercise twice a day on both legs for 12 months. They performed concentric calf rises (CR) on both legs up and eccentric CR on one leg down.
The protocol contained 15 repetitions and 3 sets on each leg with extended and flexed knee. One session contained 45 reps in the flexed position and 45 reps in the extended position, the total daily number of reps was 180. At the start, the exercises were performed with body weight. Participants could progress by adding the 5, 10 and 15 kg, if they met the criteria. The criteria for adding weight was at least one week of training at the same weight and no disabling pain during or after the exercise during the week.
Arm Title
Silbernagel group (B)
Arm Type
Active Comparator
Arm Description
Participants allocated to the Silbernagel exercise program were instructed to exercise every day with exception of the first week (every other day) for 12 months. The protocol contained 4 phases, which were based on a variety of CR exercises.
The protocol contained concentric and eccentric CR on both legs, CR on one leg, CR in sitting, CR on the step, CR without step, quick rebound CR, CR with added weight and hops on the forefoot.
The daily number of reps for 1st phase was 135, for the 2nd phase was 240, for the 3rd phase was 255 and for the 4th phase was 150. It's performed with body weight, added weight and plyometric loading progressively through all phases (maximal added weight is 15 kilos). To progress to the next phase participant needs to reach pain intensity during and after exercise under 5 from the 10 on the visual analogue scale, morning stiffness should not increase as well as pain during the week.
Intervention Type
Other
Intervention Name(s)
Alfredson protocol
Intervention Description
Alfredson eccentric therapeutical protocol.
Intervention Type
Other
Intervention Name(s)
Silbernagel protocol
Intervention Description
Silbernagel concentric-eccentric protocol.
Primary Outcome Measure Information:
Title
Victorian Institute of Sport Assessment - Achilles (VISA-A)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Biomechanical properties - stiffness
Description
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.
Time Frame
6 weeks
Title
Structure - micromorphology
Description
Fibre organisation analysis of PSFR (mmˆ-1).
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kryštof Voleský, Mgr.
Phone
+420777220281
Email
k.volesk@gmail.com
Facility Information:
Facility Name
Faculty of Physical Education and Sport at Charles University
City
Prague
State/Province
Prague 6
ZIP/Postal Code
162 52
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kateřina Wojasová
Phone
+420 774 272 772
Email
wojasova@ftvs.cuni.cz
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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31399426
Citation
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Comparison of Alfredson and Silbernagel Protocol in Competitive Athletes With Achilles Tendinopathy
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