Achilles TendinopathyNCT05659134
Comparison of Alfredson and Silbernagel Protocol in Competitive Athletes With Achilles Tendinopathy
A study testing Alfredson protocol and Silbernagel protocol in people with Achilles Tendinopathy and Tendon Injuries, run by Charles University, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Achilles Tendinopathy, Tendon Injuries, Tendon Thickening
- What is being tested?
- Alfredson protocol and Silbernagel protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 2 Dec 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Faculty of Physical Education and Sport at Charles University
Prague, Prague 6, 162 52
About this study
Official title: Comparison of Alfredson Eccentric and Silbernagel Concentric-eccentric Therapeutical Protocol in Competitive Athletes With Chronic Achilles Tendinopathy
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.
- Being tested
- Alfredson protocol, Silbernagel protocol
- Keywords
- Achilles tendinopathy, VISA-A, Ultrasound, Stiffness, Competitive athletes, Exercise therapy, Alfredson protocol, Silbernagel protocol
- Medical subject headings
- Tendon Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfredson protocolOther
Alfredson eccentric therapeutical protocol.
Silbernagel protocolOther
Silbernagel concentric-eccentric protocol.
| Study group | Role | What they receive |
|---|---|---|
| Alfredson group (A) | Active comparator | 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. Receives: Other: Alfredson protocol |
| Silbernagel group (B) | Active comparator | 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. Receives: Other: Silbernagel protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 6 weeks
Structure - micromorphology
Fibre organisation analysis of PSFR (mmˆ-1).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start2 Dec 2022
- Primary completion2 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kryštof Voleský, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659134
- Sponsor's protocol ID
- 254/21
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31399426Wang 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.
PubMed 36090915Sleeswijk 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.
PubMed 33868707van 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.
PubMed 22075719van 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.
PubMed 32522732Silbernagel 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.
PubMed 26390272Breda 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.
PubMed 33219115Habets 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.
PubMed 34722783Gravare 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.
PubMed 34797533Habets 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.
PubMed 28693535Alfredson 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.
PubMed 9617396Schneebeli 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.
PubMed 32153987Nadeau 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.
PubMed 27540416
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alfredson Eccentric and Silbernagel Concentric-eccentric Therapeutical Protocol in Competitive Athletes With Chronic Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT05659134
- Acronym / sponsor ID
- 254/21
- Keywords
- Achilles tendinopathy, VISA-A, Ultrasound, Stiffness, Competitive athletes, Exercise therapy, Alfredson protocol, Silbernagel protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 2 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alfredson group (A) | Active comparator | Other: Alfredson protocolParticipants 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. |
| Silbernagel group (B) | Active comparator | Other: Silbernagel protocolParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alfredson protocolAlfredson eccentric therapeutical protocol. | Other | Alfredson group (A) |
| Silbernagel protocolSilbernagel concentric-eccentric protocol. | Other | Silbernagel group (B) |
Primary outcome
Victorian Institute of Sport Assessment - Achilles (VISA-A)
Time frame: 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.
2 secondary outcomes
Biomechanical properties - stiffness
Time frame: 6 weeks
Structure - micromorphology
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 31399426Scott 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.
- Background: PubMed 36090915Wang 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.
- Background: PubMed 33868707Sleeswijk 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.
- Background: PubMed 22075719van 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.
- Background: PubMed 32522732van 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.
- Background: PubMed 26390272Silbernagel 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.
- Background: PubMed 33219115Breda 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.
- Background: PubMed 34722783Habets 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.
- Background: PubMed 34797533Gravare 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.
- Background: PubMed 28693535Habets 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.
- Background: PubMed 9617396Alfredson 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.
- Background: PubMed 32153987Schneebeli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alfredson protocol and Silbernagel protocol in people with Achilles Tendinopathy and Tendon Injuries, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Victorian Institute of Sport Assessment - Achilles (VISA-A) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659134, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.