Responsiveness of Quantitative Musculoskeletal Ultrasound Measures on the Healing of Achilles Tendon

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effects of Eccentric Strengthening Exercises in Adults With an Achilles Tendinopathy: Predictive Validity and Responsiveness of Quantitative Musculoskeletal Ultrasound Measures

Conditions
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Achilles Tendinopathy

Intervention / Treatment
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* Other: Eccentric strengthening exercises of the Achilles tendon


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Injured Achilles tendon participants who have an Achilles tendinopathy<br>They will do the eccentric exercise protocol and go through a series of ultrasound examination. | Other: Eccentric strengthening exercises of the Achilles tendon<br>* This exercise will require the completion of slow active eccentric plantar flexion exercises with the forefoot positioned over the edge of a step. These exercises will be repeated twice daily (three sets of 15 repetitions with the knee in extension and three sets of 15 repetitions with the knee in flexion) during a three-month period. The amount of loading will be calibrated and progressed on a weekly basis by the physiotherapist according the participant's perceived effort and pain intensity.<br>|
| Healthy Achilles tendon (contralateral) of participants who have an Achilles tendinopathy<br>They will do the eccentric exercise protocol and go through a series of ultrasound examination. | Other: Eccentric strengthening exercises of the Achilles tendon<br>* This exercise will require the completion of slow active eccentric plantar flexion exercises with the forefoot positioned over the edge of a step. These exercises will be repeated twice daily (three sets of 15 repetitions with the knee in extension and three sets of 15 repetitions with the knee in flexion) during a three-month period. The amount of loading will be calibrated and progressed on a weekly basis by the physiotherapist according the participant's perceived effort and pain intensity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responsiveness of a minimal data set of measures obtained with the QUS (quantitative ultrasonography) | The primary objective is to determine the responsiveness of a minimal data set of measures obtained with the QUS that characterize the biological integrity of the Achilles tendon (mean thickness, echogenicity, variance, homogeneity at 90 degrees, mean thickness, echogenicity and average homogeneity), after participants have completed the 12-week exercise program. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of the QUS measures' modification at 3 months post-intervention | The second objective is to determine whether the immediate changes in the biological integrity of the tendon (pre vs post-intervention), characterized by the previous measures (mean thickness, echogenicity, variance, homogeneity at 90 degrees, mean thickness, echogenicity and average homogeneity), are maintained over time (three months post-intervention). | 12 weeks |