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NCT Number: NCT04651985

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

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.

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Key information

Conditions

Achilles Tendinopathy

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Hôtel-Dieu de Montreal

Montreal, Quebec, H2W 1T7, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Eccentric strengthening exercises of the Achilles tendon

Other

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.

Primary outcomes

  1. Responsiveness of a minimal data set of measures obtained with the QUS (quantitative ultrasonography)

    Time frame: 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 outcomes

  1. Persistence of the QUS measures' modification at 3 months post-intervention

    Time frame: 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).

Other outcomes

  1. Association between the QUS measures' modification and changes in the visual analog pain scale

    Time frame: 24 weeks

    The third objective is to verify whether the immediate and persistent changes are associated with changes in the visual analog pain scale, right after the 12-week exercise program and 12 weeks after the end of the exercise program. The visual analog pain scale is a pain scale that ranges from 0 to 10; 0 represents no pain and 10 represents an excruciating pain.

  2. Association between the QUS measures' modification and changes in the Victorian Institute of Sports Assessment-Achilles questionnaire

    Time frame: 24 weeks

    The fourth objective is to verify whether the immediate and persistent changes are associated with changes in the Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A), right after the 12-week exercise program and 12 weeks after the end of the exercise program. The VISA-A score is a symptomatic scale that ranges from 0 and 100; 0 means that the participant is very symptomatic and 100 means the participant has no symptom.

  3. Association between the QUS measures' modification and changes in the Lower Extremity Functional Scale

    Time frame: 24 weeks

    The fifth objective is to verify whether the immediate and persistent changes are associated with changes in the Lower Extremity Functional Scale (LEFS), right after the 12-week exercise program and 12 weeks after the end of the exercise program. The LEFS measures the functional impact of the pathology on the participant's daily life and it ranges from 0 to 80; 0 means that the Achilles tendinopathy has an extreme functional impact and 80 means it has no impact.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2020
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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