Influencing Factors of Acute Achilles Tendinopathy in Runners (AchTend)

December 8, 2023 updated by: Jean-Sébastien Roy, Laval University

Factors Predicting the Course of Acute Achilles Tendinopathy in Runners

Achilles tendinopathy is highly prevalent in runners, but its evolution is not easily predictable. The aim of this study is to evaluate the impact of clinical and social factors on the prognosis of acute (less than 3 months) Achilles tendinopathy in runners. Runners will be evaluated in person twice. At their first visit, data related to their training (frequency, intensity, …), their running pattern (cadence, foot contact angle) and shoes (minimalist index) will be collected. Moreover, an ultrasound evaluation of Achilles tendon will be performed. At one, two and three months after their initial evaluation, participants will receive a link to complete an online survey about their pain. Three months after their initial evaluation, a second ultrasound of Achilles tendon will be performed.

Study Overview

Status

Recruiting

Conditions

Detailed Description

At their first visit, participants will read and sign the consent form. They will then fill self-report questionnaires about their pain (using the Victorian Institute of Sport Assessment for Achilles tendinopathy score and visual analog scale) and its impact on their activities, and they will be questioned on their training habits. Then, participants will be asked to run on a treadmill for five minutes at a comfortable speed. During the run, video will be recorded to evaluate to cadence and the foot contact angle. Finally, an ultrasound of Achilles tendon will be performed to evaluate thickness, area, echogenicity and inflammation of the tendon. All the images will be revised by a physician qualified in diagnostic ultrasound and the tendinopathy will be graded according to Matthew and al. model.

One, two and three months after their initial visit, participants will receive a questionnaire by email to quantify their pain. Moreover, three months after their initial visit, participants will come back in person to the laboratory. Information about their pain, training and treatment will be collected and a second ultrasound analysis will be performed.

Statistical analysis: Baseline data will be compared using independent t-test or a Mann-Whitney U test. Significant variables in the univariate analysis will be considered as potential predictor variables. Logistic analysis regression will then be performed to identify predictive factors for pain chronicity.

Study Type

Observational

Enrollment (Estimated)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1M 2S8
        • Recruiting
        • Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Runners from Québec city region with Achilles tendon pain for less than three months

Description

Inclusion Criteria:

  • Have Achilles tendon pain for less than three months
  • Run at least five kilometers per week
  • Have a score on the Victorian Institute of Sports Assessment of Achilles tendinopathy of 80 or less
  • Consent to the study

Exclusion Criteria:

  • History of Achilles tendon surgery or rupture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Acute Achilles tendinopathy
No intervention will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain graded on the visual analog scale
Time Frame: At three months
Pain graded on a 0 to 10 visual analog scale
At three months
Victorian Institute of Sports Assessment for Achilles tendinopathy (VISA-A) questionnaire
Time Frame: At three months
Pain impact score between 0 (heavily affected) and 100 (asymptomatic)
At three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thickness of the Achilles tendon
Time Frame: At three months
Ultrasound evaluation of the tendon
At three months
Area of the Achilles tendon
Time Frame: At three months
Ultrasound evaluation of the tendon
At three months
Aspect of the tendon at ultrasound evaluation graded according to Matthew and al
Time Frame: At three months
Ultrasound evaluation of the tendon
At three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-2162, _RIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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