Achilles Tendinopathy (AT)ATORNCT07497217
Change in ATOR Screening Test Scores Over 12 Weeks
A study testing Alfredson Exercise Program + Health Education + Analytical Stretching and Alfredson Exercise Program + Health Education in people with Achilles Tendinopathy (AT), run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Achilles tendinopathy (AT) is one of the most common overuse injuries in runners, with an estimated incidence ranging from 0.6% to 18.5% of all running-related injuries, reaching up to 52% in elite runners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendinopathy (AT)
- What is being tested?
- Alfredson Exercise Program + Health Education + Analytical Stretching and Alfredson Exercise Program + Health Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2026to 18 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Senior runners
- They belong to a running club
- That they have run at least 5 10-kilometer races in the past year
- They should work out at least three times a week
Who cannot join
- Runners who have received physiotherapy treatment involving invasive techniques in the last 3 months
- Runners who have received pharmacological treatment with fluoroquinolones (levofloxacin, ciprofloxacin) in the last year
- Runners with autoimmune diseases
- Individuals with limited comprehension who may be unable to answer surveys
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Centro clínico de Fisioterapia OMT-E
Zaragoza, Zaragoza, 50009
Pedro Sureda, +34 600 24 64 76, psuredam@gmail.com
About this study
Official title: Validity of a Screening Test Compared to Other Measures in Senior Runners With Achilles Tendinopathy After a Physiotherapy Protocol
Achilles tendinopathy (AT) is one of the most common overuse injuries in runners, with an estimated incidence ranging from 0.6% to 18.5% of all running-related injuries, reaching up to 52% in elite runners. Its prevalence increases significantly from the fourth decade of life due to histological changes associated with aging, such as tissue degeneration, decreased vascularization, alterations in collagen structure, reduced recovery capacity, and increased tendon stiffness. The repetitive nature of running and the high proportion of the population practicing this sport make runners, especially those over 40 years old, a particularly vulnerable group.
The etiology of AT is multifactorial and includes biomechanical, physiological, and contextual factors. Major risk factors include sudden increases in load, planning errors in training, biomechanical alterations, overweight, metabolic comorbidities such as diabetes or dyslipidemia, and exposure to certain medications, especially corticosteroids and fluoroquinolones. In middle-aged individuals, the combination of intrinsic and extrinsic factors along with structural tendon changes explains both the higher prevalence and the worse prognosis observed in this population.
Read more
Physiotherapy is one of the preferred treatments for AT, with therapeutic exercise-particularly the Alfredson protocol-being the intervention with the strongest scientific support. Despite its efficacy, between 25% and 45% of patients do not achieve full recovery, suggesting the influence of clinical, personal, and contextual factors not always considered in studies. Additionally, there is high variability in return-to-sport times, which has led to the development of specific programs for runners over 40.
In the Aragón community, there are no studies describing the extent of AT in senior runners nor systematically analyzing their clinical characteristics, comorbidities, referral patterns, or healthcare service use. This lack of information hampers evidence-based decision-making and the planning of preventive and therapeutic strategies in physiotherapy. This study aims to fill this gap by providing contextualized information to improve clinical practice, healthcare pathways, and physiotherapeutic guidelines.
The hypothesis of the study is that an assessment system using screening has validity for detecting clinical changes in senior runners with Achilles tendon pain. The main objective is to determine the validity of this screening compared to other clinical measures after applying a physiotherapy protocol.
A clinimetric validity design is proposed. The sample will include 40 runners over 40 years old, belonging to sports clubs, who train at least three days a week and have participated in at least five 10 km races in the past year. Participants will be recruited through running clubs and social media, and randomly assigned to two groups of 20 people each. Exclusion criteria include recent invasive treatments, use of fluoroquinolones in the last year, autoimmune diseases, or difficulties understanding questionnaires.
Data collected will include sociodemographic, anthropometric, sports activity, and clinical variables through validated scales (VISA-A, NPRS, IPAQ, and SMFA), as well as ultrasound characteristics of the tendon, ankle mobility, passive calcaneal mobility, and functional screening tests based on active movements and jumps.
The procedure involves initial measurements, random assignment to control or experimental groups, and a 12-week home self-treatment program. Both groups will perform the Alfredson exercise protocol and receive health education; the experimental group will add analytical stretching of the posterior chain following OMT methodology.
Statistical analysis will assess intergroup and intragroup differences using repeated measures ANOVA, analyze time-group interactions, and include sensitivity-to-change statistics such as effect size, minimal clinically important difference, and reliable change index.
A gender perspective will be incorporated, limiting the representation of one sex to a maximum of 70% of the sample and analyzing results separately by gender. Main limitations include the small sample size, short follow-up duration, and limited control over adherence to home treatment.
Finally, the study clearly defines internal and external validity and clarifies the use of the term screening as a functional discrimination tool within a homogeneous and clinically defined population, without asserting generalization to the broader population.
- Conditions
- Achilles Tendinopathy (AT)
- Being tested
- Alfredson Exercise Program + Health Education + Analytical Stretching, Alfredson Exercise Program + Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfredson Exercise Program + Health Education + Analytical StretchingOther
Compared with the other intervention in this study, this approach adds analytical stretching and self-stretching of the gastrocnemius and soleus muscles, following the Kaltenborn-Evjenth method, in patients with Achilles tendinopathy
Alfredson Exercise Program + Health EducationOther
Compared with the other intervention in this study, this approach does not include analytical stretching and self-stretching of the gastrocnemius and soleus muscles based on the Kaltenborn-Evjenth method in patients with Achilles tendinopathy
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: Alfredson exercises + health education + analytical stretching | Experimental | Program 1 Receives: Other: Alfredson Exercise Program + Health Education + Analytical Stretching |
| Control group: Alfredson exercises + health education | Experimental | Program 2 Receives: Other: Alfredson Exercise Program + Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in total screening score (sum of five test scores) at 12 weeks
The total movement screening score is calculated as the sum of five movement-based tests assessing [e.g., mobility, stability, and functional movement]. Each test is scored independently according to predefined criteria, and the total score represents overall movement performance. Change from baseline is defined as the difference between baseline and 12-week values.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
Mean change from baseline in Achilles tendon thickness measured by ultrasound at two anatomical points at 12 weeks
Achilles tendon thickness will be measured using ultrasound at two predefined anatomical points along the tendon. Measurements will be recorded in millimeters. Change from baseline is defined as the difference between baseline and 12-week values.
Measured: From enrollment to the end of treatment at 12 weeks
Mean change from baseline in VISA-A score at 12 weeks
The Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire will be used to assess symptoms and function in patients with Achilles tendinopathy. The VISA-A score ranges from 0 to 100, with higher scores indicating better function and fewer symptoms. Change from baseline is defined as the difference between baseline and 12-week values.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start16 Feb 2026
- Primary completion18 May 2026 (estimated)
- Study completion18 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendinopathy (AT)Studies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Hijazo Larrosa, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497217
- Sponsor's protocol ID
- PI22/179
- Acronym
- ATOR
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study collects clinical and functional information from patients with Achilles tendinopathy, including demographic data, pain measures, functional tests, and patient-reported outcomes. However, the informed consent for this trial does not include permission for secondary use or external sharing of de-identified individual data. In addition, the purpose of the study is to evaluate two specific physiotherapy-based intervention programs, and the dataset is not intended for broader data-sharing or secondary analyses outside the primary research group.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of a Screening Test Compared to Other Measures in Senior Runners With Achilles Tendinopathy After a Physiotherapy Protocol
- ClinicalTrials.gov ID
- NCT07497217
- Acronym / sponsor ID
- ATOR / PI22/179
- Conditions
- Achilles Tendinopathy (AT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 18 May 2026 (estimated)
- Study completion
- 18 Jul 2026 (estimated)
- First posted
- 27 Mar 2026 (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 one of the most common overuse injuries in runners, with an estimated incidence ranging from 0.6% to 18.5% of all running-related injuries, reaching up to 52% in elite runners. Its prevalence increases significantly from the fourth decade of life due to histological changes associated with aging, such as tissue degeneration, decreased vascularization, alterations in collagen structure, reduced recovery capacity, and increased tendon stiffness. The repetitive nature of running and the high proportion of the population practicing this sport make runners, especially those over 40 years old, a particularly vulnerable group.
The etiology of AT is multifactorial and includes biomechanical, physiological, and contextual factors. Major risk factors include sudden increases in load, planning errors in training, biomechanical alterations, overweight, metabolic comorbidities such as diabetes or dyslipidemia, and exposure to certain medications, especially corticosteroids and fluoroquinolones. In middle-aged individuals, the combination of intrinsic and extrinsic factors along with structural tendon changes explains both the higher prevalence and the worse prognosis observed in this population.
Physiotherapy is one of the preferred treatments for AT, with therapeutic exercise-particularly the Alfredson protocol-being the intervention with the strongest scientific support. Despite its efficacy, between 25% and 45% of patients do not achieve full recovery, suggesting the influence of clinical, personal, and contextual factors not always considered in studies. Additionally, there is high variability in return-to-sport times, which has led to the development of specific programs for runners over 40.
In the Aragón community, there are no studies describing the extent of AT in senior runners nor systematically analyzing their clinical characteristics, comorbidities, referral patterns, or healthcare service use. This lack of information hampers evidence-based decision-making and the planning of preventive and therapeutic strategies in physiotherapy. This study aims to fill this gap by providing contextualized information to improve clinical practice, healthcare pathways, and physiotherapeutic guidelines.
The hypothesis of the study is that an assessment system using screening has validity for detecting clinical changes in senior runners with Achilles tendon pain. The main objective is to determine the validity of this screening compared to other clinical measures after applying a physiotherapy protocol.
A clinimetric validity design is proposed. The sample will include 40 runners over 40 years old, belonging to sports clubs, who train at least three days a week and have participated in at least five 10 km races in the past year. Participants will be recruited through running clubs and social media, and randomly assigned to two groups of 20 people each. Exclusion criteria include recent invasive treatments, use of fluoroquinolones in the last year, autoimmune diseases, or difficulties understanding questionnaires.
Data collected will include sociodemographic, anthropometric, sports activity, and clinical variables through validated scales (VISA-A, NPRS, IPAQ, and SMFA), as well as ultrasound characteristics of the tendon, ankle mobility, passive calcaneal mobility, and functional screening tests based on active movements and jumps.
The procedure involves initial measurements, random assignment to control or experimental groups, and a 12-week home self-treatment program. Both groups will perform the Alfredson exercise protocol and receive health education; the experimental group will add analytical stretching of the posterior chain following OMT methodology.
Statistical analysis will assess intergroup and intragroup differences using repeated measures ANOVA, analyze time-group interactions, and include sensitivity-to-change statistics such as effect size, minimal clinically important difference, and reliable change index.
A gender perspective will be incorporated, limiting the representation of one sex to a maximum of 70% of the sample and analyzing results separately by gender. Main limitations include the small sample size, short follow-up duration, and limited control over adherence to home treatment.
Finally, the study clearly defines internal and external validity and clarifies the use of the term screening as a functional discrimination tool within a homogeneous and clinically defined population, without asserting generalization to the broader population.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: Alfredson exercises + health education + analytical stretching | Experimental | Other: Alfredson Exercise Program + Health Education + Analytical StretchingProgram 1 |
| Control group: Alfredson exercises + health education | Experimental | Other: Alfredson Exercise Program + Health EducationProgram 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Senior runners
- They belong to a running club
- That they have run at least 5 10-kilometer races in the past year
- They should work out at least three times a week
Key exclusion criteria (4 listed)
- Runners who have received physiotherapy treatment involving invasive techniques in the last 3 months
- Runners who have received pharmacological treatment with fluoroquinolones (levofloxacin, ciprofloxacin) in the last year
- Runners with autoimmune diseases
- Individuals with limited comprehension who may be unable to answer surveys
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 Exercise Program + Health Education + Analytical StretchingCompared with the other intervention in this study, this approach adds analytical stretching and self-stretching of the gastrocnemius and soleus muscles, following the Kaltenborn-Evjenth method, in patients with Achilles tendinopathy | Other | Experimental group: Alfredson exercises + health education + analytical stretching |
| Alfredson Exercise Program + Health EducationCompared with the other intervention in this study, this approach does not include analytical stretching and self-stretching of the gastrocnemius and soleus muscles based on the Kaltenborn-Evjenth method in patients with Achilles tendinopathy | Other | Control group: Alfredson exercises + health education |
Primary outcome
Mean change from baseline in total screening score (sum of five test scores) at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
The total movement screening score is calculated as the sum of five movement-based tests assessing [e.g., mobility, stability, and functional movement]. Each test is scored independently according to predefined criteria, and the total score represents overall movement performance. Change from baseline is defined as the difference between baseline and 12-week values.
2 secondary outcomes
Mean change from baseline in Achilles tendon thickness measured by ultrasound at two anatomical points at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change from baseline in VISA-A score at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. This study collects clinical and functional information from patients with Achilles tendinopathy, including demographic data, pain measures, functional tests, and patient-reported outcomes. However, the informed consent for this trial does not include permission for secondary use or external sharing of de-identified individual data. In addition, the purpose of the study is to evaluate two specific physiotherapy-based intervention programs, and the dataset is not intended for broader data-sharing or secondary analyses outside the primary research group.
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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.
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 Exercise Program + Health Education + Analytical Stretching and Alfredson Exercise Program + Health Education in people with Achilles Tendinopathy (AT), run by Universidad de Zaragoza at 1 site in Spain.
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 4 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: looking for participants now, as of the sponsor's last update on 2 Apr 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergio Hijazo, Phd (+34 673 74 40 10, shijazo@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in total screening score (sum of five test scores) at 12 weeks (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.