Clinical trial NCT04651985: Responsiveness of Quantitative Musculoskeletal Ultrasound Measures on the Healing of Achilles Tendon
Official title: Effects of Eccentric Strengthening Exercises in Adults With an Achilles Tendinopathy: Predictive Validity and Responsiveness of Quantitative Musculoskeletal Ultrasound Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendinopathy
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from patients with symptoms consistent with AT in the middle third of the Achilles tendon for at least six weeks. They will be recruited from physical therapy clinics, sports medicine clinic, sports teams and athletic clubs.

Brief summary: To this day, the most accepted treatment for the Achilles tendinopathy (AT) remains the exercise program to strengthen the plantar flexor muscles. The eccentric exercises protocol proposed by Alfredson is the most popular and recommended one by the rehabilitation professionals. Currently, the response to interventions is measured almost exclusively by clinical data, especially using questionnaires, since the Quantitative Ultrasound (QUS) is rarely used. In fact, the thickness of the Achilles tendon, which is generally the only measure noted when using musculoskeletal ultrasound on AT, does not allow the clinician to confirm an improvement following an eccentric exercise program if the tendon is thinner, especially in adults with chronic AT. No scientific evidence indicates whether there is an improvement in the biological integrity of the Achilles tendon following the completion of Alfredson's eccentric strengthening protocol. This is why it seems relevant to use the pre-established minimal biomarker data set obtained with the QUS in order to study the variation of these data in response to a rehabilitation intervention and to verify how these variations influence clinical data.

Detailed description: A comprehensive clinical evaluation (questionnaires, clinical examination and ultrasound imaging) will be completed immediately before the intervention (pre), immediately after the intervention (post), and three months after the intervention (follow-up).

Eligibility criteria: Inclusion Criteria:

* Symptoms consistent with AT in the middle third of the Achilles tendon for at least six weeks
* AT signs objectified by the physical exam and the ultrasound imaging at the initial evaluation
* At least 18 years old
* Victorian Institute of Sport Assessment-Achilles Questionnaire (VISA-A) score below 90
* have pain of at least 3 out of 10 according to the analog visual scale during athletic activities

Exclusion Criteria:

* Pain at the Achilles tendon enthesis
* A complete rupture of the Achilles tendon History of Achilles tendon rupture Inflammatory arthropathy
* Sign of neurological lesion on physical examination of the lower limb
* Neurological disease (e.g. multiple sclerosis, stroke)
* History of intervention of the Achilles tendon or ankle (e.g. surgery, cortisone infiltration, extracorporeal shock waves therapy, platelet-rich plasma injection).

Primary outcomes:
measure: Responsiveness of a minimal data set of measures obtained with the QUS (quantitative ultrasonography)
timeFrame: 12 weeks
Secondary outcomes:
measure: Persistence of the QUS measures' modification at 3 months post-intervention
timeFrame: 12 weeks
Other outcomes:
measure: Association between the QUS measures' modification and changes in the visual analog pain scale
timeFrame: 24 weeks
measure: Association between the QUS measures' modification and changes in the Victorian Institute of Sports Assessment-Achilles questionnaire
timeFrame: 24 weeks
measure: Association between the QUS measures' modification and changes in the Lower Extremity Functional Scale
timeFrame: 24 weeks
Locations:
city: Montreal
country: Canada
facility: Hôpital Hôtel-Dieu de Montreal
state: Quebec
Study officials:
affiliation: Centre Hospitalier Universitaire de Montreal (CHUM)
name: Martin Lamontagne, MD
role: PRINCIPAL_INVESTIGATOR
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