Achilles TendinopathyAchTendNCT05677204
Influencing Factors of Acute Achilles Tendinopathy in Runners
An observational study of Achilles Tendinopathy, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendinopathy
- How many people
- 95 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Runners from Québec city region with Achilles tendon pain for less than three months
Who may be able to join
- 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
Who cannot join
- History of Achilles tendon surgery or rupture
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
Québec, Quebec, G1M 2S8
Jean-Sébastien Roy, PT, PhD, 1-418-529-9141 ext. 6005, jean-sebastien.roy@fmed.ulaval.ca
About this study
Official title: 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.
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.
- Conditions
- Achilles Tendinopathy
- Keywords
- Runners, Acute, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Achilles tendinopathy | No intervention will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain graded on the visual analog scale
Pain graded on a 0 to 10 visual analog scale
Measured: At three months
Victorian Institute of Sports Assessment for Achilles tendinopathy (VISA-A) questionnaire
Pain impact score between 0 (heavily affected) and 100 (asymptomatic)
Measured: At three months
Secondary outcomes (3)
Thickness of the Achilles tendon
Ultrasound evaluation of the tendon
Measured: At three months
Area of the Achilles tendon
Ultrasound evaluation of the tendon
Measured: At three months
Aspect of the tendon at ultrasound evaluation graded according to Matthew and al
Ultrasound evaluation of the tendon
Measured: At three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Jun 2022
- Primary completion30 Jun 2023
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Sébastien Roy, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677204
- Sponsor's protocol ID
- 2021-2162, _RIS
- Acronym
- AchTend
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 22075193Esculier 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 26300981Matthews 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predicting the Course of Acute Achilles Tendinopathy in Runners
- ClinicalTrials.gov ID
- NCT05677204
- Acronym / sponsor ID
- AchTend / 2021-2162, _RIS
- Conditions
- Achilles Tendinopathy
- Keywords
- Runners, Acute, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Jan 2023 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Achilles tendinopathy | – | –No intervention will be given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Runners from Québec city region with Achilles tendon pain for less than three months
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- History of Achilles tendon surgery or rupture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain graded on the visual analog scale
Time frame: At three months
Pain graded on a 0 to 10 visual analog scale
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)
3 secondary outcomes
Thickness of the Achilles tendon
Time frame: At three months
Area of the Achilles tendon
Time frame: At three months
Aspect of the tendon at ultrasound evaluation graded according to Matthew and al
Time frame: At three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 22075193Altman 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.
- Background: PubMed 26300981Esculier 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.
- Background: PubMed 32341798Matthews 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.
- Individual participant dataSharing planned: Undecided
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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.
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 Laval University at 1 site in Canada.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Sebastien Roy, PT,PhD (1-418-529-9141 ext. 6005, jean-sebastien.roy@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain graded on the visual analog scale (time frame: At three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677204, which also lists 3 linked publications.
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 11 Dec 2023.