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RecruitingNCT05677204AchTendUpdated Dec 11, 2023

Influencing Factors of Acute Achilles Tendinopathy in Runners

An observational study in Achilles Tendinopathy, sponsored by Laval University. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.

Sponsored by Laval University · Observational

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
95
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Achilles Tendinopathy

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Keywords

  • Runners
  • Acute
  • Prognosis
03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's planned enrollment of 95 is above the median of 67 across 52 observational studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

Exclusion Criteria:

  • History of Achilles tendon surgery or rupture
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
95 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acute Achilles tendinopathy

    No intervention will be given

06

What researchers measure

Primary outcomes

  1. Pain graded on the visual analog scale

    Pain graded on a 0 to 10 visual analog scale

    Time frame: At three months

  2. Victorian Institute of Sports Assessment for Achilles tendinopathy (VISA-A) questionnaire

    Pain impact score between 0 (heavily affected) and 100 (asymptomatic)

    Time frame: At three months

Secondary outcomes

  1. Thickness of the Achilles tendon

    Ultrasound evaluation of the tendon

    Time frame: At three months

  2. Area of the Achilles tendon

    Ultrasound evaluation of the tendon

    Time frame: At three months

  3. Aspect of the tendon at ultrasound evaluation graded according to Matthew and al

    Ultrasound evaluation of the tendon

    Time frame: At three months

07

Study locations

1 of 1 sites recruiting
  • Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
    Quebec City, Quebec G1M 2S8, Canada
    Recruiting
08

References and documents

Publications

  • Altman AR, Davis IS. A kinematic method for footstrike pattern detection in barefoot and shod runners. Gait Posture. 2012 Feb;35(2):298-300. doi: 10.1016/j.gaitpost.2011.09.104. Epub 2011 Nov 8. PubMed 22075193 ↗
  • Esculier JF, Dubois B, Dionne CE, Leblond J, Roy JS. A consensus definition and rating scale for minimalist shoes. J Foot Ankle Res. 2015 Aug 19;8:42. doi: 10.1186/s13047-015-0094-5. eCollection 2015. PubMed 26300981 ↗
  • Matthews W, Ellis R, Furness JW, Rathbone E, Hing W. Staging achilles tendinopathy using ultrasound imaging: the development and investigation of a new ultrasound imaging criteria based on the continuum model of tendon pathology. BMJ Open Sport Exerc Med. 2020 Mar 25;6(1):e000699. doi: 10.1136/bmjsem-2019-000699. eCollection 2020. PubMed 32341798 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05677204
Lead sponsor
Laval University
Responsible party
Jean-Sébastien Roy (Principal Investigator, Laval University) — Principal investigator
First posted
Jan 10, 2023
Start date
Jun 1, 2022
Primary completion
Jun 30, 2023
Completion
Dec 2023 (estimated)
Last update
Dec 11, 2023

Study contacts

Jean-Sebastien Roy, PT,PhD
Contact
jean-sebastien.roy@fmed.ulaval.ca
1-418-529-9141 ext. 6005
Marie-Helene Lavallee-Bourget
Contact
marie-helene.lavallee-bourget.1@ulaval.ca
1-418 265-1721

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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