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

Sponsor

Charles University, Czech Republic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05659134

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendinopathy Tendon Injuries Tendon Thickening Pain, Chronic	Other: Alfredson protocol Other: Silbernagel protocol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 2, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Alfredson group (A) 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.	Other: Alfredson protocol Alfredson eccentric therapeutical protocol.
Active Comparator: Silbernagel group (B) 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.	Other: Silbernagel protocol Silbernagel concentric-eccentric protocol.

Arm

Intervention/Treatment

Active Comparator: Alfredson group (A)

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.

Other: Alfredson protocol

Alfredson eccentric therapeutical protocol.

Active Comparator: Silbernagel group (B)

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.

Other: Silbernagel protocol

Silbernagel concentric-eccentric protocol.

Outcome Measures

Primary Outcome Measures

Victorian Institute of Sport Assessment - Achilles (VISA-A) [1 year]
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 [6 weeks]
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 [6 weeks]
Fibre organisation analysis of PSFR (mmˆ-1).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)