Change in ATOR Screening Test Scores Over 12 Weeks

NCT07497217 | Recruiting

• 1 other identifier: PI22/179
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Achilles Tendinopathy (AT)

Outcome Measures

Primary Outcomes (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.

  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

  From enrollment to the end of treatment at 12 weeks

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

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (4)

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

  From enrollment to the end of treatment at 12 weeks

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

  From enrollment to the end of treatment at 12 weeks

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

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Experimental group: Alfredson exercises + health education + analytical stretching

EXPERIMENTAL

Program 1

Other: Alfredson Exercise Program + Health Education + Analytical Stretching

Control group: Alfredson exercises + health education

EXPERIMENTAL

Program 2

Other: Alfredson Exercise Program + Health Education

Interventions

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

Experimental group: Alfredson exercises + health education + analytical stretching

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

Control group: Alfredson exercises + health education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Centro clínico de Fisioterapia OMT-E

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

Central Study Contacts

Sergio Hijazo, Phd

CONTACT

+34 673 74 40 10; shijazo@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: March 27, 2026
• Study Start: February 16, 2026
• Primary Completion: May 18, 2026
• Study Completion (Estimated): July 18, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)