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NCT Number: NCT07497217

Change in ATOR Screening Test Scores Over 12 Weeks

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Alfredson Exercise Program + Health Education + Analytical Stretching

Other

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 Education

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Mean change from baseline in VISA-A score at 12 weeks

    Time frame: From enrollment to the end of treatment 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.

Other outcomes

  1. Mean change from baseline in pain intensity measured by Numeric Pain Rating Scale (NPRS) at 12 weeks

    Time frame: From enrollment to the end of treatment at 12 weeks

    Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Change from baseline is defined as the difference between baseline and 12-week values.

  2. Mean change from baseline in physical activity level measured by the International Physical Activity Questionnaire (IPAQ) at 12 weeks

    Time frame: From enrollment to the end of treatment at 12 weeks

    Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Results will be expressed according to standard scoring protocols (e.g., MET-minutes/week). Change from baseline is defined as the difference between baseline and 12-week values.

  3. Mean change from baseline in functional status measured by the Short Musculoskeletal Function Assessment (SMFA) at 12 weeks

    Time frame: From enrollment to the end of treatment at 12 weeks

    Functional status will be assessed using the Short Musculoskeletal Function Assessment (SMFA) questionnaire. Scores will be calculated according to standard scoring procedures, with higher scores indicating worse function. Change from baseline is defined as the difference between baseline and 12-week values.

  4. Mean change from baseline in ankle dorsiflexion range of motion at 12 weeks

    Time frame: From enrollment to the end of treatment at 12 weeks

    Ankle dorsiflexion range of motion will be measured in degrees using a goniometer. Passive ankle mobility will be assessed through standardized physiotherapy examination procedures. Change from baseline is defined as the difference between baseline and 12-week values.

Study contacts

Contact information is provided by the study sponsor or research team.

Sergio Hijazo, Phd

CONTACT

[email protected]

+34 673 74 40 10

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

Validity of a Screening Test Compared to Other Measures in Senior Runners With Achilles Tendinopathy After a Physiotherapy Protocol

Acronym: ATOR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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