Achilles TendinopathyNCT07039643
Pilates Method in Achilles Tendinopathy Rehabilitation
A study testing Pilates exercise and Alfredson protocol in people with Achilles Tendinopathy and Eccentric Exercise, run by University of West Attica at 1 site in Greece.
Trial summary
Achilles Tendinopathy (AT) is characterized by pain, swelling and dysfunction. Rehabilitation strategies focus on conservative treatment, with eccentric exercise being the main and most popular option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendinopathy, Eccentric Exercise, Pilates Method
- What is being tested?
- Pilates exercise and Alfredson protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGreece
- Study dates
- 19 May 2025to 8 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 years of age with clinically diagnosed Achilles tendinopathy.
- Ability to understand the study procedures and provide written informed consent.
- Sufficient knowledge of the Greek language to complete the assessment procedures and questionnaires.
Who cannot join
- Previous surgery involving the Achilles Tendon or ankle region
- History of malignancy, systemic disease, neurological disorder
- Chronic corticosteroid use or corticosteroid injection in the affected tendon region within the previous 4 weeks.
- Participation in another exercise rehabilitation or conservative treatment program for Achilles tendinopathy within the previous 4 weeks.
- Any condition limiting safe participation in an exercise-based rehabilitation program.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Physiotherapy Department, University of West Attica
Athens, Aigaleo, 12243
About this study
Official title: The Pilates Method in the Rehabilitation of Achilles Tendinopathy - A Randomized Controlled Trial
Achilles Tendinopathy (AT) is characterized by pain, swelling and dysfunction. Rehabilitation strategies focus on conservative treatment, with eccentric exercise being the main and most popular option. Patient education based on the biopsychosocial model is considered important for effective self-management, including modification of activities and loads and pain monitoring. Established exercise protocols are applied in rehabilitation, with eccentric, eccentric- concentric combinations and high-resistance exercises performed at a slow pace being the most popular. The Pilates method , which has gained popularity in recent years, focuses on core stabilization, motor control, correct posture through respiratory patterns during execution as well as flow and mindfulness and is applied to the rehabilitation of various musculoskeletal disorders. Although there is a research background in rehabilitation, the data for its application in AT are limited. The present study aims to investigate the integration of Pilates into clinical practice for AT.
Read the detailed description
This study was designed as a pragmatic, parallel-group randomized controlled trial in individuals with Achilles tendinopathy. Participants were randomly allocated to either a Pilates-based rehabilitation group (intervention group) or an Alfredson eccentric loading group (control group) using a computer-generated random allocation sequence and sealed, opaque, sequentially numbered envelopes prepared by an independent researcher. Due to the nature of the interventions, participant and therapist blinding was not feasible. However, outcome assessment was performed by an assessor blinded to group allocation.
Different members of the research team were responsible for participant recruitment, randomization, intervention delivery, and outcome assessment in order to minimize potential bias and ensure allocation concealment. Participants were instructed not to disclose details of their intervention during outcome assessments. Adherence monitoring differed between groups according to the nature of the interventions. In the control group, participants received weekly follow-up communication and were encouraged to maintain adherence logs. In the Pilates group, adherence was monitored through supervised session attendance and rescheduling procedures when necessary.
Participants were recruited through referrals from healthcare professionals and public invitations for voluntary participation. Eligible participants were adults over 18 years of age with clinically diagnosed Achilles tendinopathy. Written informed consent was obtained prior to participation, and all participant data were pseudonymized using unique identification codes.
The intervention group followed an 8-week supervised Pilates-based rehabilitation program using Reformer equipment, with two 60-minute sessions per week and a 12-week follow-up assessment. The intervention incorporated progressive and individualized loading principles, motor control training, core stabilization, controlled movement execution, and functional progression according to symptom tolerance and participant performance.
The control group followed a 12-week modified Alfredson eccentric loading protocol. Participants performed a progressive home-based eccentric loading program involving exercises with the knee extended and flexed, adapted according to pain tolerance and symptom behavior. Weekly communication and monitoring were performed to support adherence and progression.
Outcome measures were collected at baseline and at 4, 8 and 12 weeks. Outcome assessment included patient-reported and functional measures evaluating pain, symptoms, kinesiophobia and functional performance in accordance with contemporary recommendations for Achilles tendinopathy assessment and the International Scientific Tendinopathy Symposium Consensus ICON/COS-AT framework.
An a priori sample size calculation using repeated measures ANOVA indicated that 128 participants would be required for adequate statistical power. Due to the pragmatic clinical design and recruitment feasibility, 49 participants were randomized and 45 completed the study. Statistical analysis was performed using repeated measures ANOVA to evaluate the effects of time, intervention group and time-by-group interaction across the assessment points. The study was designed primarily to evaluate feasibility, adherence, safety, acceptability and preliminary clinical response rather than to establish superiority between interventions.
- Being tested
- Pilates exercise, Alfredson protocol
- Keywords
- Achilles tendinopathy, Achilles Tendon injuries, exercise, Rehabilitation, Pilates exercise, Pilates method, Pilates
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exerciseOther
This study investigates a Pilates-based rehabilitation program for individuals with Achilles tendinopathy (AT). Although eccentric loading protocols remain the most commonly applied conservative treatment approach, some individuals demonstrate persistent symptoms, limited adherence, or difficulty tolerating high-load exercise programs. The Pilates method incorporates principles of core stabilization, motor control, movement quality, postural alignment, and progressive functional loading, potentially offering an alternative rehabilitation approach for individuals with AT. The present trial aims to evaluate the feasibility, adherence, safety, and preliminary clinical response of a Pilates-based intervention in relation to pain, function, kinesiophobia, and functional performance.
Alfredson protocolOther
This study compares Alfredson eccentric loading protocol, which is one of the most commonly applied rehabilitation approaches for Achilles tendinopathy, with an alternative exercise-based rehabilitation program incorporating Pilates principles and progressive functional loading.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Pilates Group | Experimental | Group A will follow exercise sessions based on the Pilates method. The protocol will be determined and performed twice a week for 60 minutes, for 8 weeks with a 12 week follow-up. The Pilates will be performed on Reformer equipment and at the final stages jumboard will be added. Receives: Other: Pilates exercise |
| Group B: Alfredson Group | Active comparator | Group B will follow the Alfredson Protocol at home with a diary. Instructions at the beginning will ensure the correct execution while there will be communication once a week to ensure the commitment and compliance. Participants will have to perform 3 sets of 15 repetitions of each exercise 7 days a week for 12 weeks. Receives: Other: Alfredson protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
TENDINS-A
TENDINS - A is a new, valid and reliable outcome measure that assesses pain, symptoms and physical activity. It exhibits adequate content validity and is considered the most representative tool for quantifying the effectiveness of interventions in Achilles tendon rehabilitation . tendinopathy ( Murphy and al ., 2024). The study on cross-cultural adaptation-translation and validity-reliability in the Greek language received approval from the Hellenic National Institute of Language and Culture with protocol number 102962/05-11-2024 . The results of the study were used to determine the characteristics of the main study sample.
Measured: Data collection will take place at 4 time points 0,4,8,12 weeks.
Secondary outcomes (3)
Single- leg heel -rise test
The heel rise test records the number of repetitions until pain or fatigue occurs, while its effectiveness in assessing functional recovery has been documented with the maximum strength of recommendation (A) ( Silbernagel and al ., 2020).
Measured: Data collection will take place at 4 time points 0,4,8,12 weeks.
Tampa Scale for Kinesiophobia ( TSK)
Fear of movement and physical activity will be assessed with the Greek version of the Tampa scale. Scale for Kinesiophobia ( Georgoudis) and al ., 2005; Miller and al ., 1991). The TSK is a valid and reliable self-assessment tool that includes two subscales : activity avoidance and bodily focus-perception.
The total score ranges from 17 to 68, where 17 indicates no kinesiophobia and 68 indicates severe kinesiophobia . A score > 37 indicates the presence of kinesiophobia .
Measured: Data collection will take place at 4 time points 0,4,8,12 weeks.
VAS scale
Visual Analogue Scale for Pain describes pain from 0 to 10. O dercribes a condition free of pain while 10 derscribes most pain.
Measured: Data collection will take place at 4 time points 0,4,8,12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start19 May 2025
- Primary completion30 Sep 2025
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- 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
- Model description
- Parallel Assignment. This is a randomised controlled trial with primary end point at 8 weeks for the intervention group and second primary point at 12 weeks while the end point for the control group will be at 12 weeks. Participants will be allocated randomly into two groups (intervention and control).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AIKATERINI SIVRIKA, University of West Attica
- Investigators
- AIKATERINI P SIVRIKA, PhDc, Principal investigator, University of West AtticaDimitrios Stasinopoulos, PhD, Study director, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039643
- Sponsor's protocol ID
- 41860/07-05-2025
- Status last verified
- May 2026
- First submitted
- 17 Jun 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and data protection restrictions.
Publications
Sivrika AP, Kypraios G, Lamnisos D, Georgoudis G, Stasinopoulos D. Pilates Dosage in Rehabilitation of Patients With Musculoskeletal Conditions: A Scoping Review. Sports Health. 2025 Jul;17(4):824-833. doi: 10.1177/19417381241278263. Epub 2024 Sep 19.
PubMed 39297289Sivrika AP, Papadamou E, Kypraios G, Lamnisos D, Georgoudis G, Stasinopoulos D. Comparability of the Effectiveness of Different Types of Exercise in the Treatment of Achilles Tendinopathy: A Systematic Review. Healthcare (Basel). 2023 Aug 11;11(16):2268. doi: 10.3390/healthcare11162268.
PubMed 37628466Murphy MC, Newsham-West R, Cook J, Chimenti RL, de Vos RJ, Maffulli N, Malliaras P, Mkumbuzi N, Purdam C, Vosseller JT, Rio EK. TENDINopathy Severity Assessment - Achilles (TENDINS-A): Development and Content Validity Assessment of a New Patient-Reported Outcome Measure for Achilles Tendinopathy. J Orthop Sports Phys Ther. 2024 Jan;54(1):70-85. doi: 10.2519/jospt.2023.11964.
PubMed 37615161Merry K, MacPherson M, Vis-Dunbar M, Whittaker JL, Gravare Silbernagel K, Scott A. Identifying characteristics of resistance-based therapeutic exercise interventions for Achilles tendinopathy: A scoping review. Phys Ther Sport. 2023 Sep;63:73-94. doi: 10.1016/j.ptsp.2023.06.002. Epub 2023 Jul 1.
PubMed 37536026Malliaras P. Physiotherapy management of Achilles tendinopathy. J Physiother. 2022 Oct;68(4):221-237. doi: 10.1016/j.jphys.2022.09.010. Epub 2022 Oct 21. No abstract available.
PubMed 36274038de Vos RJ, van der Vlist AC, Zwerver J, Meuffels DE, Smithuis F, van Ingen R, van der Giesen F, Visser E, Balemans A, Pols M, Veen N, den Ouden M, Weir A. Dutch multidisciplinary guideline on Achilles tendinopathy. Br J Sports Med. 2021 Oct;55(20):1125-1134. doi: 10.1136/bjsports-2020-103867. Epub 2021 Jun 29.
PubMed 34187784
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pilates Method in the Rehabilitation of Achilles Tendinopathy - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07039643
- Acronym / sponsor ID
- 41860/07-05-2025
- Keywords
- Achilles tendinopathy, Achilles Tendon injuries, exercise, Rehabilitation, Pilates exercise, Pilates method, Pilates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 26 Jun 2025 (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.
Achilles Tendinopathy (AT) is characterized by pain, swelling and dysfunction. Rehabilitation strategies focus on conservative treatment, with eccentric exercise being the main and most popular option. Patient education based on the biopsychosocial model is considered important for effective self-management, including modification of activities and loads and pain monitoring. Established exercise protocols are applied in rehabilitation, with eccentric, eccentric- concentric combinations and high-resistance exercises performed at a slow pace being the most popular. The Pilates method , which has gained popularity in recent years, focuses on core stabilization, motor control, correct posture through respiratory patterns during execution as well as flow and mindfulness and is applied to the rehabilitation of various musculoskeletal disorders. Although there is a research background in rehabilitation, the data for its application in AT are limited. The present study aims to investigate the integration of Pilates into clinical practice for AT.
Detailed description
This study was designed as a pragmatic, parallel-group randomized controlled trial in individuals with Achilles tendinopathy. Participants were randomly allocated to either a Pilates-based rehabilitation group (intervention group) or an Alfredson eccentric loading group (control group) using a computer-generated random allocation sequence and sealed, opaque, sequentially numbered envelopes prepared by an independent researcher. Due to the nature of the interventions, participant and therapist blinding was not feasible. However, outcome assessment was performed by an assessor blinded to group allocation.
Different members of the research team were responsible for participant recruitment, randomization, intervention delivery, and outcome assessment in order to minimize potential bias and ensure allocation concealment. Participants were instructed not to disclose details of their intervention during outcome assessments. Adherence monitoring differed between groups according to the nature of the interventions. In the control group, participants received weekly follow-up communication and were encouraged to maintain adherence logs. In the Pilates group, adherence was monitored through supervised session attendance and rescheduling procedures when necessary.
Participants were recruited through referrals from healthcare professionals and public invitations for voluntary participation. Eligible participants were adults over 18 years of age with clinically diagnosed Achilles tendinopathy. Written informed consent was obtained prior to participation, and all participant data were pseudonymized using unique identification codes.
The intervention group followed an 8-week supervised Pilates-based rehabilitation program using Reformer equipment, with two 60-minute sessions per week and a 12-week follow-up assessment. The intervention incorporated progressive and individualized loading principles, motor control training, core stabilization, controlled movement execution, and functional progression according to symptom tolerance and participant performance.
The control group followed a 12-week modified Alfredson eccentric loading protocol. Participants performed a progressive home-based eccentric loading program involving exercises with the knee extended and flexed, adapted according to pain tolerance and symptom behavior. Weekly communication and monitoring were performed to support adherence and progression.
Outcome measures were collected at baseline and at 4, 8 and 12 weeks. Outcome assessment included patient-reported and functional measures evaluating pain, symptoms, kinesiophobia and functional performance in accordance with contemporary recommendations for Achilles tendinopathy assessment and the International Scientific Tendinopathy Symposium Consensus ICON/COS-AT framework.
An a priori sample size calculation using repeated measures ANOVA indicated that 128 participants would be required for adequate statistical power. Due to the pragmatic clinical design and recruitment feasibility, 49 participants were randomized and 45 completed the study. Statistical analysis was performed using repeated measures ANOVA to evaluate the effects of time, intervention group and time-by-group interaction across the assessment points. The study was designed primarily to evaluate feasibility, adherence, safety, acceptability and preliminary clinical response rather than to establish superiority between interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment. This is a randomised controlled trial with primary end point at 8 weeks for the intervention group and second primary point at 12 weeks while the end point for the control group will be at 12 weeks. Participants will be allocated randomly into two groups (intervention and control).
| Arm | Type | Receives |
|---|---|---|
| Group A: Pilates Group | Experimental | Other: Pilates exerciseGroup A will follow exercise sessions based on the Pilates method. The protocol will be determined and performed twice a week for 60 minutes, for 8 weeks with a 12 week follow-up. The Pilates will be performed on Reformer equipment and at the final stages jumboard will be added. |
| Group B: Alfredson Group | Active comparator | Other: Alfredson protocolGroup B will follow the Alfredson Protocol at home with a diary. Instructions at the beginning will ensure the correct execution while there will be communication once a week to ensure the commitment and compliance. Participants will have to perform 3 sets of 15 repetitions of each exercise 7 days a week for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over 18 years of age with clinically diagnosed Achilles tendinopathy.
- Ability to understand the study procedures and provide written informed consent.
- Sufficient knowledge of the Greek language to complete the assessment procedures and questionnaires.
Key exclusion criteria (5 listed)
- Previous surgery involving the Achilles Tendon or ankle region
- History of malignancy, systemic disease, neurological disorder
- Chronic corticosteroid use or corticosteroid injection in the affected tendon region within the previous 4 weeks.
- Participation in another exercise rehabilitation or conservative treatment program for Achilles tendinopathy within the previous 4 weeks.
- Any condition limiting safe participation in an exercise-based rehabilitation program.
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 |
|---|---|---|
| Pilates exerciseThis study investigates a Pilates-based rehabilitation program for individuals with Achilles tendinopathy (AT). Although eccentric loading protocols remain the most commonly applied conservative treatment approach, some individuals demonstrate persistent symptoms, limited adherence, or difficulty tolerating high-load exercise programs. The Pilates method incorporates principles of core stabilization, motor control, movement quality, postural alignment, and progressive functional loading, potentially offering an alternative rehabilitation approach for individuals with AT. The present trial aims to evaluate the feasibility, adherence, safety, and preliminary clinical response of a Pilates-based intervention in relation to pain, function, kinesiophobia, and functional performance. | Other | Group A: Pilates Group |
| Alfredson protocolThis study compares Alfredson eccentric loading protocol, which is one of the most commonly applied rehabilitation approaches for Achilles tendinopathy, with an alternative exercise-based rehabilitation program incorporating Pilates principles and progressive functional loading. | Other | Group B: Alfredson Group |
Primary outcome
TENDINS-A
Time frame: Data collection will take place at 4 time points 0,4,8,12 weeks.
TENDINS - A is a new, valid and reliable outcome measure that assesses pain, symptoms and physical activity. It exhibits adequate content validity and is considered the most representative tool for quantifying the effectiveness of interventions in Achilles tendon rehabilitation . tendinopathy ( Murphy and al ., 2024). The study on cross-cultural adaptation-translation and validity-reliability in the Greek language received approval from the Hellenic National Institute of Language and Culture with protocol number 102962/05-11-2024 . The results of the study were used to determine the characteristics of the main study sample.
3 secondary outcomes
Single- leg heel -rise test
Time frame: Data collection will take place at 4 time points 0,4,8,12 weeks.
Tampa Scale for Kinesiophobia ( TSK)
Time frame: Data collection will take place at 4 time points 0,4,8,12 weeks.
VAS scale
Time frame: Data collection will take place at 4 time points 0,4,8,12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Results publication: PubMed 39297289Sivrika AP, Kypraios G, Lamnisos D, Georgoudis G, Stasinopoulos D. Pilates Dosage in Rehabilitation of Patients With Musculoskeletal Conditions: A Scoping Review. Sports Health. 2025 Jul;17(4):824-833. doi: 10.1177/19417381241278263. Epub 2024 Sep 19.
- Results publication: PubMed 37628466Sivrika AP, Papadamou E, Kypraios G, Lamnisos D, Georgoudis G, Stasinopoulos D. Comparability of the Effectiveness of Different Types of Exercise in the Treatment of Achilles Tendinopathy: A Systematic Review. Healthcare (Basel). 2023 Aug 11;11(16):2268. doi: 10.3390/healthcare11162268.
- Results publication: PubMed 37615161Murphy MC, Newsham-West R, Cook J, Chimenti RL, de Vos RJ, Maffulli N, Malliaras P, Mkumbuzi N, Purdam C, Vosseller JT, Rio EK. TENDINopathy Severity Assessment - Achilles (TENDINS-A): Development and Content Validity Assessment of a New Patient-Reported Outcome Measure for Achilles Tendinopathy. J Orthop Sports Phys Ther. 2024 Jan;54(1):70-85. doi: 10.2519/jospt.2023.11964.
- Results publication: PubMed 37536026Merry K, MacPherson M, Vis-Dunbar M, Whittaker JL, Gravare Silbernagel K, Scott A. Identifying characteristics of resistance-based therapeutic exercise interventions for Achilles tendinopathy: A scoping review. Phys Ther Sport. 2023 Sep;63:73-94. doi: 10.1016/j.ptsp.2023.06.002. Epub 2023 Jul 1.
- Results publication: PubMed 36274038Malliaras P. Physiotherapy management of Achilles tendinopathy. J Physiother. 2022 Oct;68(4):221-237. doi: 10.1016/j.jphys.2022.09.010. Epub 2022 Oct 21. No abstract available.
- Results publication: PubMed 34187784de Vos RJ, van der Vlist AC, Zwerver J, Meuffels DE, Smithuis F, van Ingen R, van der Giesen F, Visser E, Balemans A, Pols M, Veen N, den Ouden M, Weir A. Dutch multidisciplinary guideline on Achilles tendinopathy. Br J Sports Med. 2021 Oct;55(20):1125-1134. doi: 10.1136/bjsports-2020-103867. Epub 2021 Jun 29.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and data protection restrictions.
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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.
AIKATERINI P SIVRIKA, PhDc principal investigator
University of West Attica
Dimitrios Stasinopoulos, PhD study director
University of West Attica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercise and Alfredson protocol in people with Achilles Tendinopathy and Eccentric Exercise, run by University of West Attica at 1 site in Greece.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 13 May 2026. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TENDINS-A (time frame: Data collection will take place at 4 time points 0,4,8,12 weeks.). 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 NCT07039643, which also lists 6 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 13 May 2026.