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

Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651985
• Other study ID #: 2021-9100
• Status: Completed
• Start date: August 31, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: November 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

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.

Locations

Country	Name	City	State
Canada	Hôpital Hôtel-Dieu de Montreal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & Publications (16)

Alfredson H, Pietilä 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. — View Citation

Beyer R, Kongsgaard M, Hougs Kjær B, Øhlenschlæger T, Kjær 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: 10.1177/036354 — View Citation

Binkley 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. — View Citation

Cardoso 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. Review. — View Citation

Collinger 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- — View Citation

de 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. — View Citation

Färnqvist 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. Review. — View Citation

Kudron 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. — View Citation

Lalumiere M, Larivière 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 Bi — View Citation

McAuliffe 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- — View Citation

Nadeau MJ, Desrochers A, Lamontagne M, Larivière 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 — View Citation

Ortega-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 Rehabi — View Citation

Price 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. — View Citation

Rompe 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. Epub 2007 Jan 23. Erratum — View Citation

Sunding K, Fahlström M, Werner S, Forssblad M, Willberg L. Evaluation of Achilles and patellar tendinopathy with greyscale ultrasound and colour Doppler: using a four-grade scale. Knee Surg Sports Traumatol Arthrosc. 2016 Jun;24(6):1988-96. doi: 10.1007/s — View Citation

Wearing 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: 10.115 — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association between the QUS measures' modification and changes in the visual analog pain scale	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
Other	Association between the QUS measures' modification and changes in the Victorian Institute of Sports Assessment-Achilles questionnaire	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
Other	Association between the QUS measures' modification and changes in the Lower Extremity Functional Scale	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
Primary	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	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