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

Completed

• Conditions: Achilles Tendinopathy
• Interventions: Other: Eccentric strengthening exercises of the Achilles tendon

• Registration Number: NCT04651985
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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).

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-03
• Study Start: 2021-08-31
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Injured Achilles tendon participants who have an Achilles tendinopathy	Eccentric strengthening exercises of the Achilles tendon	They will do the eccentric exercise protocol and go through a series of ultrasound examination.
Healthy Achilles tendon (contralateral) of participants who have an Achilles tendinopathy	Eccentric strengthening exercises of the Achilles tendon	They will do the eccentric exercise protocol and go through a series of ultrasound examination.

Primary Outcome Measures

Name	Time	Method
Responsiveness of a minimal data set of measures obtained with the QUS (quantitative ultrasonography)	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Persistence of the QUS measures' modification at 3 months post-intervention	12 weeks	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).

Trial Locations

Locations (1)

Hôpital Hôtel-Dieu de Montreal; 🇨🇦 Montreal, Quebec, Canada