Influencing Factors of Acute Achilles Tendinopathy in Runners

Achilles Tendinopathy Clinical Trial

— AchTend  

Official title:

Factors Predicting the Course of Acute Achilles Tendinopathy in Runners

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677204
• Other study ID #: 2021-2162, _RIS
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: Laval University
• Contact: Jean-Sebastien Roy, PT,PhD
• Phone: 1-418-529-9141
• Email: jean-sebastien.roy[@]fmed.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: December 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Locations

Country	Name	City	State
Canada	Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain graded on the visual analog scale	Pain graded on a 0 to 10 visual analog scale	At three months
Primary	Victorian Institute of Sports Assessment for Achilles tendinopathy (VISA-A) questionnaire	Pain impact score between 0 (heavily affected) and 100 (asymptomatic)	At three months
Secondary	Thickness of the Achilles tendon	Ultrasound evaluation of the tendon	At three months
Secondary	Area of the Achilles tendon	Ultrasound evaluation of the tendon	At three months
Secondary	Aspect of the tendon at ultrasound evaluation graded according to Matthew and al	Ultrasound evaluation of the tendon	At three months