Achilles TendinopathyNCT07275112
Cross-cultural an Reliability and Validity Evaluation of TENDINS-A in Spain
An observational study of Achilles Tendinopathy, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Volunteers who want to participate in the study will read the general information of the study and sign the informed consent to participate in the study. Once the informed consent has been read and delivered, the evaluator will check that they meet the inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Cross-cultural adaptation and Evaluation of reliability and validity
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2025to 19 Jan 2026
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Achilles tendinopathy
Who may be able to join
- Present Achilles tendinopathy
- Accept participation in the study (acceptance of informed consent)
- Being a native Spanish speaker
- Be in an age range between 18 and 55 years.
- Do not present any exclusion criteria.
Who cannot join
- Complete or partial tendon rupture
- Other recent injuries in the affected limb
- Previous surgery in the limb
- Haglund syndrome
- Inflammatory diseases
- Autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-cultural Adaptation of the TENDINopathy Severity Assessment-Achilles (TENDINS-A) for the Spanish Population and Evaluation of Its Reliability and Validity in Accordance With COSMIN Recommendations
Volunteers who want to participate in the study will read the general information of the study and sign the informed consent to participate in the study.
Once the informed consent has been read and delivered, the evaluator will check that they meet the inclusion criteria. After the data collection, a randomization (Epidat V4.0) of the selected subjects will be carried out to assign them to one of the intervention groups.
Read more
Patients must present Achilles pathology and will be recruited through a network of physiotherapy clinics distributed across Spain.
The physiotherapist responsible for their treatment will invite them to participate in the study by providing a QR code granting access to all relevant study documentation. This documentation will include a checkbox in which the patient must indicate that, after reading all the pertinent information, they consent to participate. Without this explicit consent, marked via the checkbox, participation will not be possible.
Once consent is provided, the patient will gain access to three questionnaires to be completed at the same time: VISA-A, FAOS, and TENDINS-A. After 48 hours, they will receive a link to complete the TENDINS-A retest.
When the participant has completed all four questionnaires (VISA-A, FAOS, TENDINS-A, and the TENDINS-A retest), their participation in the study will be considered complete.
The sample size will be calculated following COSMIN recommendations, aiming for a minimum of more than 100 participants to ensure excellent reliability.
- Conditions
- Achilles Tendinopathy
- Being tested
- Cross-cultural adaptation, Evaluation of reliability and validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-cultural adaptationOther
Cultural and linguistic adaptation process including forward/back translation, expert review, and cognitive debriefing and forward translation, back-translation, expert panel evaluation, cognitive interviews.
Evaluation of reliability and validityOther
Administration of adapted instrument for reliability and validity assessment and psychometric testing of the adapted questionnaire to evaluate reliability and validity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reliability (Intraclass Correlation Coefficient (ICC 2,1)).
Degree of stability of the adapted questionnaire scores when administered twice to the same participants under similar conditions. ICC values with 95% confidence intervals.
Measured: Baseline and 2-3 days after the first administration.
Internal consistency (Cronbach's alpha coefficient; ranges from 0 to 1.).
Internal homogeneity of the items of the adapted questionnaire. Calculation of Cronbach's alpha for total score and subscales (if applicable). 0.90 or higher: Excellent reliability.
0.80 to 0.89: Good internal consistency. 0.70 to 0.79: Acceptable reliability (the minimum standard in research). Less than 0.50: Unacceptable consistency.
Measured: At baseline.
Construct validity
Degree to which the adapted instrument reflects the theoretical construct it is intended to measure. Exploratory Factor Analysis (EFA) and/or Confirmatory Factor Analysis (CFA), depending on design.
Measured: At baseline.
Secondary outcomes (5)
Age (years)
Measured: At baseline.
Sex (Male and female)
Measured: At baseline.
Weight (kg)
Measured: At baseline.
BMI (body max index kg/cm2)
Measured: At baseline.
Height (cm)
Measured: At baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start5 Dec 2025
- Primary completion1 Jan 2026
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275112
- Sponsor's protocol ID
- CEEI 24/558
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation of the TENDINopathy Severity Assessment-Achilles (TENDINS-A) for the Spanish Population and Evaluation of Its Reliability and Validity in Accordance With COSMIN Recommendations
- ClinicalTrials.gov ID
- NCT07275112
- Acronym / sponsor ID
- CEEI 24/558
- Conditions
- Achilles Tendinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 10 Dec 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.
Volunteers who want to participate in the study will read the general information of the study and sign the informed consent to participate in the study.
Once the informed consent has been read and delivered, the evaluator will check that they meet the inclusion criteria. After the data collection, a randomization (Epidat V4.0) of the selected subjects will be carried out to assign them to one of the intervention groups.
Patients must present Achilles pathology and will be recruited through a network of physiotherapy clinics distributed across Spain.
The physiotherapist responsible for their treatment will invite them to participate in the study by providing a QR code granting access to all relevant study documentation. This documentation will include a checkbox in which the patient must indicate that, after reading all the pertinent information, they consent to participate. Without this explicit consent, marked via the checkbox, participation will not be possible.
Once consent is provided, the patient will gain access to three questionnaires to be completed at the same time: VISA-A, FAOS, and TENDINS-A. After 48 hours, they will receive a link to complete the TENDINS-A retest.
When the participant has completed all four questionnaires (VISA-A, FAOS, TENDINS-A, and the TENDINS-A retest), their participation in the study will be considered complete.
The sample size will be calculated following COSMIN recommendations, aiming for a minimum of more than 100 participants to ensure excellent reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Achilles tendinopathy
Key inclusion criteria (5 listed)
- Present Achilles tendinopathy
- Accept participation in the study (acceptance of informed consent)
- Being a native Spanish speaker
- Be in an age range between 18 and 55 years.
- Do not present any exclusion criteria.
Key exclusion criteria (6 listed)
- Complete or partial tendon rupture
- Other recent injuries in the affected limb
- Previous surgery in the limb
- Haglund syndrome
- Inflammatory diseases
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 |
|---|---|---|
| Cross-cultural adaptationCultural and linguistic adaptation process including forward/back translation, expert review, and cognitive debriefing and forward translation, back-translation, expert panel evaluation, cognitive interviews. | Other | – |
| Evaluation of reliability and validityAdministration of adapted instrument for reliability and validity assessment and psychometric testing of the adapted questionnaire to evaluate reliability and validity. | Other | – |
Primary outcome
Test-retest reliability (Intraclass Correlation Coefficient (ICC 2,1)).
Time frame: Baseline and 2-3 days after the first administration.
Degree of stability of the adapted questionnaire scores when administered twice to the same participants under similar conditions. ICC values with 95% confidence intervals.
Internal consistency (Cronbach's alpha coefficient; ranges from 0 to 1.).
Time frame: At baseline.
Internal homogeneity of the items of the adapted questionnaire. Calculation of Cronbach's alpha for total score and subscales (if applicable). 0.90 or higher: Excellent reliability. 0.80 to 0.89: Good internal consistency. 0.70 to 0.79: Acceptable reliability (the minimum standard in research). Less than 0.50: Unacceptable consistency.
Construct validity
Time frame: At baseline.
Degree to which the adapted instrument reflects the theoretical construct it is intended to measure. Exploratory Factor Analysis (EFA) and/or Confirmatory Factor Analysis (CFA), depending on design.
5 secondary outcomes
Age (years)
Time frame: At baseline.
Sex (Male and female)
Time frame: At baseline.
Weight (kg)
Time frame: At baseline.
BMI (body max index kg/cm2)
Time frame: At baseline.
Height (cm)
Time frame: At baseline.
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 21 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendinopathy, run by Cardenal Herrera University 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 5 inclusion and 6 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 21 Jan 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?
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?
Test-retest reliability (Intraclass Correlation Coefficient (ICC 2,1)). (time frame: Baseline and 2-3 days after the first administration.). The study lists 3 primary outcomes in all. 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 21 Jan 2026.