NCT05677204

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

December 22, 2022

Last Update Submit

December 8, 2023

Conditions

Keywords

RunnersAcutePrognosis

Outcome Measures

Primary Outcomes (2)

  • Pain graded on the visual analog scale

    Pain graded on a 0 to 10 visual analog scale

    At three months

  • 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 Outcomes (3)

  • Thickness of the Achilles tendon

    At three months

  • Area of the Achilles tendon

    At three months

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

    At three months

Study Arms (1)

Acute Achilles tendinopathy

No intervention will be given

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • History of Achilles tendon surgery or rupture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)

Québec, Quebec, G1M 2S8, Canada

RECRUITING

Related 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.

    PMID: 22075193BACKGROUND
  • 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.

    PMID: 26300981BACKGROUND
  • 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.

    PMID: 32341798BACKGROUND

Central Study Contacts

Jean-Sebastien Roy, PT,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 10, 2023

Study Start

June 1, 2022

Primary Completion

June 30, 2023

Study Completion

December 1, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations