Achilles TendinopathyNCT04651985
Responsiveness of Quantitative Musculoskeletal Ultrasound Measures on the Healing of Achilles Tendon
An observational study of Achilles Tendinopathy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Eccentric strengthening exercises of the Achilles tendon
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2021to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Achilles Tendinopathy
- Being tested
- Eccentric strengthening exercises of the Achilles tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric strengthening exercises of the Achilles tendonOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Injured Achilles tendon participants who have an Achilles tendinopathy | They will do the eccentric exercise protocol and go through a series of ultrasound examination. Receives: Other: Eccentric strengthening exercises of the Achilles tendon | |
| 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. Receives: Other: Eccentric strengthening exercises of the Achilles tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start31 Aug 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Lamontagne, MD, Principal investigator, Centre Hospitalier Universitaire de Montreal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651985
- Sponsor's protocol ID
- 2021-9100
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.
PubMed 9617396Beyer R, Kongsgaard M, Hougs Kjaer B, Ohlenschlaeger T, Kjaer M, Magnusson SP. Heavy Slow Resistance Versus Eccentric Training as Treatment for Achilles Tendinopathy: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1704-11. doi: 10.1177/0363546515584760. Epub 2015 May 27.
PubMed 26018970Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
PubMed 10201543Cardoso TB, Pizzari T, Kinsella R, Hope D, Cook JL. Current trends in tendinopathy management. Best Pract Res Clin Rheumatol. 2019 Feb;33(1):122-140. doi: 10.1016/j.berh.2019.02.001. Epub 2019 Mar 8.
PubMed 31431267Collinger JL, Fullerton B, Impink BG, Koontz AM, Boninger ML. Validation of grayscale-based quantitative ultrasound in manual wheelchair users: relationship to established clinical measures of shoulder pathology. Am J Phys Med Rehabil. 2010 May;89(5):390-400. doi: 10.1097/PHM.0b013e3181d8a238.
PubMed 20407304de Jonge S, van den Berg C, de Vos RJ, van der Heide HJ, Weir A, Verhaar JA, Bierma-Zeinstra SM, Tol JL. Incidence of midportion Achilles tendinopathy in the general population. Br J Sports Med. 2011 Oct;45(13):1026-8. doi: 10.1136/bjsports-2011-090342.
PubMed 21926076Farnqvist K, Pearson S, Malliaras P. Adaptation of Tendon Structure and Function in Tendinopathy With Exercise and Its Relationship to Clinical Outcome. J Sport Rehabil. 2020 Jan 1;29(1):107-115. doi: 10.1123/jsr.2018-0353.
PubMed 30860421Kudron C, Carlson MJ, Meron A, Sridhar B, Brakke Holman R. Using Ultrasound Measurement of the Achilles Tendon in Asymptomatic Runners to Assist in Predicting Tendinopathy. J Ultrasound Med. 2020 Mar;39(3):491-496. doi: 10.1002/jum.15125. Epub 2019 Sep 6.
PubMed 31490583Lalumiere M, Lariviere C, Nadeau MJ, Paquette P, Lamontagne M, Desmeules F, Gagnon DH. Proposing a Minimal Data Set of Musculoskeletal Ultrasound Imaging Biomarkers to Inform Clinical Practice: An Analysis Founded on the Achilles Tendon. Ultrasound Med Biol. 2020 Sep;46(9):2222-2235. doi: 10.1016/j.ultrasmedbio.2020.04.024. Epub 2020 Jun 8.
PubMed 32527592McAuliffe S, Tabuena A, McCreesh K, O'Keeffe M, Hurley J, Comyns T, Purtill H, O'Neill S, O'Sullivan K. Altered Strength Profile in Achilles Tendinopathy: A Systematic Review and Meta-Analysis. J Athl Train. 2019 Aug;54(8):889-900. doi: 10.4085/1062-6050-43-18. Epub 2019 Aug 6.
PubMed 31386582Nadeau MJ, Desrochers A, Lamontagne M, Lariviere C, Gagnon DH. Quantitative ultrasound imaging of Achilles tendon integrity in symptomatic and asymptomatic individuals: reliability and minimal detectable change. J Foot Ankle Res. 2016 Aug 17;9:30. doi: 10.1186/s13047-016-0164-3. eCollection 2016.
PubMed 27540416Ortega-Avila AB, Reina-Martin I, Cervera-Garvi P, Lopezosa-Reca E, Cabello-Manrique D, Gijon-Nogueron G. Systematic review of the psychometric properties of the Victorian Institute of Sports Assessment - Achilles tendinopathy questionnaire. Disabil Rehabil. 2021 Apr;43(8):1056-1064. doi: 10.1080/09638288.2019.1652701. Epub 2019 Aug 20.
PubMed 31429326Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 6226917Wearing SC, Grigg NL, Hooper SL, Smeathers JE. Conditioning of the Achilles tendon via ankle exercise improves correlations between sonographic measures of tendon thickness and body anthropometry. J Appl Physiol (1985). 2011 May;110(5):1384-9. doi: 10.1152/japplphysiol.00075.2011. Epub 2011 Mar 10.
PubMed 21393469Rompe JD, Nafe B, Furia JP, Maffulli N. Eccentric loading, shock-wave treatment, or a wait-and-see policy for tendinopathy of the main body of tendo Achillis: a randomized controlled trial. Am J Sports Med. 2007 Mar;35(3):374-83. doi: 10.1177/0363546506295940. Epub 2007 Jan 23.
PubMed 17244902
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eccentric Strengthening Exercises in Adults With an Achilles Tendinopathy: Predictive Validity and Responsiveness of Quantitative Musculoskeletal Ultrasound Measures
- ClinicalTrials.gov ID
- NCT04651985
- Acronym / sponsor ID
- 2021-9100
- Conditions
- Achilles Tendinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injured Achilles tendon participants who have an Achilles tendinopathy | – | Other: Eccentric strengthening exercises of the Achilles tendonThey 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 | – | Other: Eccentric strengthening exercises of the Achilles tendonThey will do the eccentric exercise protocol and go through a series of ultrasound examination. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric strengthening exercises of the Achilles tendonThis 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. | Other | Healthy Achilles tendon (contralateral) of participants who have an Achilles tendinopathy, Injured Achilles tendon participants who have an Achilles tendinopathy |
Primary outcome
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.
1 secondary outcome
Persistence of the QUS measures' modification at 3 months post-intervention
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Results publication: PubMed 9617396Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.
- Results publication: PubMed 26018970Beyer R, Kongsgaard M, Hougs Kjaer B, Ohlenschlaeger T, Kjaer M, Magnusson SP. Heavy Slow Resistance Versus Eccentric Training as Treatment for Achilles Tendinopathy: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1704-11. doi: 10.1177/0363546515584760. Epub 2015 May 27.
- Results publication: PubMed 10201543Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
- Results publication: PubMed 31431267Cardoso TB, Pizzari T, Kinsella R, Hope D, Cook JL. Current trends in tendinopathy management. Best Pract Res Clin Rheumatol. 2019 Feb;33(1):122-140. doi: 10.1016/j.berh.2019.02.001. Epub 2019 Mar 8.
- Results publication: PubMed 20407304Collinger JL, Fullerton B, Impink BG, Koontz AM, Boninger ML. Validation of grayscale-based quantitative ultrasound in manual wheelchair users: relationship to established clinical measures of shoulder pathology. Am J Phys Med Rehabil. 2010 May;89(5):390-400. doi: 10.1097/PHM.0b013e3181d8a238.
- Results publication: PubMed 21926076de Jonge S, van den Berg C, de Vos RJ, van der Heide HJ, Weir A, Verhaar JA, Bierma-Zeinstra SM, Tol JL. Incidence of midportion Achilles tendinopathy in the general population. Br J Sports Med. 2011 Oct;45(13):1026-8. doi: 10.1136/bjsports-2011-090342.
- Results publication: PubMed 30860421Farnqvist K, Pearson S, Malliaras P. Adaptation of Tendon Structure and Function in Tendinopathy With Exercise and Its Relationship to Clinical Outcome. J Sport Rehabil. 2020 Jan 1;29(1):107-115. doi: 10.1123/jsr.2018-0353.
- Results publication: PubMed 31490583Kudron C, Carlson MJ, Meron A, Sridhar B, Brakke Holman R. Using Ultrasound Measurement of the Achilles Tendon in Asymptomatic Runners to Assist in Predicting Tendinopathy. J Ultrasound Med. 2020 Mar;39(3):491-496. doi: 10.1002/jum.15125. Epub 2019 Sep 6.
- Results publication: PubMed 32527592Lalumiere M, Lariviere C, Nadeau MJ, Paquette P, Lamontagne M, Desmeules F, Gagnon DH. Proposing a Minimal Data Set of Musculoskeletal Ultrasound Imaging Biomarkers to Inform Clinical Practice: An Analysis Founded on the Achilles Tendon. Ultrasound Med Biol. 2020 Sep;46(9):2222-2235. doi: 10.1016/j.ultrasmedbio.2020.04.024. Epub 2020 Jun 8.
- Results publication: PubMed 31386582McAuliffe S, Tabuena A, McCreesh K, O'Keeffe M, Hurley J, Comyns T, Purtill H, O'Neill S, O'Sullivan K. Altered Strength Profile in Achilles Tendinopathy: A Systematic Review and Meta-Analysis. J Athl Train. 2019 Aug;54(8):889-900. doi: 10.4085/1062-6050-43-18. Epub 2019 Aug 6.
- Results publication: PubMed 27540416Nadeau MJ, Desrochers A, Lamontagne M, Lariviere C, Gagnon DH. Quantitative ultrasound imaging of Achilles tendon integrity in symptomatic and asymptomatic individuals: reliability and minimal detectable change. J Foot Ankle Res. 2016 Aug 17;9:30. doi: 10.1186/s13047-016-0164-3. eCollection 2016.
- Results publication: PubMed 31429326Ortega-Avila AB, Reina-Martin I, Cervera-Garvi P, Lopezosa-Reca E, Cabello-Manrique D, Gijon-Nogueron G. Systematic review of the psychometric properties of the Victorian Institute of Sports Assessment - Achilles tendinopathy questionnaire. Disabil Rehabil. 2021 Apr;43(8):1056-1064. doi: 10.1080/09638288.2019.1652701. Epub 2019 Aug 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Lamontagne, MD principal investigator
Centre Hospitalier Universitaire de Montreal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendinopathy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responsiveness of a minimal data set of measures obtained with the QUS (quantitative ultrasonography) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04651985, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.