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

NCT04651985 | Completed

• 1 other identifier: 2021-9100
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  12 weeks

Other Outcomes (3)

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

  24 weeks

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

  24 weeks

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

  24 weeks

Study Arms (2)

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

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

Interventions

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.

Healthy Achilles tendon (contralateral) of participants who have an Achilles tendinopathy; Injured Achilles tendon participants who have an Achilles tendinopathy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Hôpital Hôtel-Dieu de Montreal

Montreal, Quebec, H2W 1T7, Canada

Location

Related Publications (16)

• 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.

  PMID: 9617396 RESULT

• Beyer 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.

  PMID: 26018970 RESULT

• 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.

  PMID: 10201543 RESULT

• 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.

  PMID: 31431267 RESULT

• 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):390-400. doi: 10.1097/PHM.0b013e3181d8a238.

  PMID: 20407304 RESULT

• 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.

  PMID: 21926076 RESULT

• Farnqvist 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.

  PMID: 30860421 RESULT

• 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.

  PMID: 31490583 RESULT

• Lalumiere 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.

  PMID: 32527592 RESULT

• 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: 10.4085/1062-6050-43-18. Epub 2019 Aug 6.

  PMID: 31386582 RESULT

• Nadeau 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.

  PMID: 27540416 RESULT

• 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 Rehabil. 2021 Apr;43(8):1056-1064. doi: 10.1080/09638288.2019.1652701. Epub 2019 Aug 20.

  PMID: 31429326 RESULT

• 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.

  PMID: 6226917 RESULT

• 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: 10.1152/japplphysiol.00075.2011. Epub 2011 Mar 10.

  PMID: 21393469 RESULT

• 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. doi: 10.1177/0363546506295940. Epub 2007 Jan 23.

  PMID: 17244902 RESULT

• Sunding K, Fahlstrom 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/s00167-014-3270-4. Epub 2014 Sep 6.

  PMID: 25193569 RESULT

Study Officials

• Martin Lamontagne, MD

  Centre Hospitalier Universitaire de Montreal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 3, 2020
• Study Start: August 31, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)