AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Sergio Hijazo, Phd contact

+34 673 74 40 10

shijazo@unizar.es

Spain1 site, 1 recruiting
  • Centro clínico de Fisioterapia OMT-E

    Zaragoza, Zaragoza, 50009

    Pedro Sureda, +34 600 24 64 76, psuredam@gmail.com

    Recruiting

Other trials in Spain

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.

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 groups in NCT07497217
Study groupRoleWhat they receive
Experimental group: Alfredson exercises + health education + analytical stretchingExperimentalProgram 1
Receives: Other: Alfredson Exercise Program + Health Education + Analytical Stretching
Control group: Alfredson exercises + health educationExperimentalProgram 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted27 Mar 2026
  2. Study start16 Feb 2026
  3. Primary completion18 May 2026 (estimated)
  4. Study completion18 Jul 2026 (estimated)

Resources

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)
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.

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.

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