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

November 2, 2022 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T7
        • Hôpital Hôtel-Dieu de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks
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.
24 weeks
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Martin Lamontagne, MD, Centre Hospitalier Universitaire de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2021

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-9100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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