NCT06867211

Brief Summary

Background: Achilles tendon thickness has been associated with various diseases. Among imaging modalities, ultrasonography stands out because of its advantages in assessing Achilles tendon thickness. Previous studies typically recommend performing Achilles tendon ultrasonography with the patient in a prone position on an examination table. However, because it is not always possible or safe for each patient to assume the prone position, this study aimed to investigate the relationship between measurements obtained in the supine position and those obtained using the standard method. Methods: A total of 180 healthy volunteers aged ≥18 years (70 female and 110 male; 360 Achilles tendons), with no history of disease or medication use, were included in the study. Achilles tendon measurements (thickness, width, and cross-sectional area) were obtained via ultrasonography in four different positions, including the standard method. The alternative methods included the supine position with the leg extended (Method 2), the supine position with the ankle resting on the opposite knee (Method 3), and the supine position with the leg held in the air at 90 degrees of hip and knee flexion (Method 4). Measurements were taken 2 cm distal from the Achilles tendon insertion on the calcaneus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

February 27, 2025

Last Update Submit

March 4, 2025

Conditions

Keywords

achilles tendonemergency medicineultrasonography

Outcome Measures

Primary Outcomes (1)

  • A novel ultrasonographic technique for achilles tendon thickness measurement

    The primary outcome of this study was to provide a practical method for Achilles tendon measurement in emergency departments by addressing the disadvantages of the prone measurement technique proposed in previous studies.

    Baseline

Study Arms (1)

Use of Ultrasonography for Measuring Achilles Tendon Thickness

Diagnostic Test: Use of Ultrasonography for Measuring Achilles Tendon Thickness

Interventions

Achilles tendon ultrasonography was performed on healthy volunteers included in the study by an emergency physician trained in both basic and advanced ultrasonography techniques. Measurements were conducted using a Butterfly iQ (Butterfly Network, Inc., Guilford, CT) ultrasound device in B-mode with a musculoskeletal preset, using biplane imaging. For Achilles tendon measurement, the image depth was set to 2.0 cm. A linear probe was placed longitudinally and perpendicular to the tendon. The distal portion of the Achilles tendon and the calcaneus were visualized in the long axis, whereas the short axis was used to center the Achilles tendon on the screen for an optimal measurement view. The measurement site was determined as 2 cm proximal to the Achilles tendon insertion at the calcaneus. In biplane imaging, Achilles tendon thickness was measured in the long axis, whereas thickness, width, and cross-sectional area were measured in the short axis. Measurements were performed bilaterally

Use of Ultrasonography for Measuring Achilles Tendon Thickness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sample size for this study was calculated to include at least 180 volunteers, based on a moderate effect size, an error margin of 0.05, a power of 80%, and a correlation analysis approach.

You may qualify if:

  • Healthy volunteers aged \>18 years who agreed to participate in the study

You may not qualify if:

  • Individuals with tenosynovitis, tendinitis, bursitis, tuberculous arthritis, rheumatoid arthritis, a history of Achilles tendon surgery, or tendon injuries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Training and Research Hospital

Sakarya, Adapazarı, 54100, Turkey (Türkiye)

Location

Related Publications (7)

  • Sharifaskari A, Goodarzi A, Davoody N, Kianmehr N, Sepyani A, Haghighi A. Sonographic assessment of Achilles tendon in patients with cutaneous psoriasis. Caspian J Intern Med. 2024 Spring;15(2):313-317. doi: 10.22088/cjim.15.2.313.

    PMID: 38807726BACKGROUND
  • Tharwat S, Saleh M, Elrefaey R, Nassar MK, Nassar MK. Clinical and Ultrasonographic Characteristics of the Achilles Tendon in Hemodialysis Patients. Medicina (Kaunas). 2023 Dec 15;59(12):2181. doi: 10.3390/medicina59122181.

    PMID: 38138284BACKGROUND
  • Silbernagel KG, Shelley K, Powell S, Varrecchia S. Extended field of view ultrasound imaging to evaluate Achilles tendon length and thickness: a reliability and validity study. Muscles Ligaments Tendons J. 2016 May 19;6(1):104-10. doi: 10.11138/mltj/2016.6.1.104. eCollection 2016 Jan-Mar.

    PMID: 27331037BACKGROUND
  • Del Bano-Aledo ME, Martinez-Paya JJ, Rios-Diaz J, Mejias-Suarez S, Serrano-Carmona S, de Groot-Ferrando A. Ultrasound measures of tendon thickness: Intra-rater, Inter-rater and Inter-machine reliability. Muscles Ligaments Tendons J. 2017 May 10;7(1):192-199. doi: 10.11138/mltj/2017.7.1.192. eCollection 2017 Jan-Mar.

    PMID: 28717629BACKGROUND
  • Yuzawa K, Yamakawa K, Tohno E, Seki M, Akisada M, Yanagi H, Okafuji T, Yamanouchi Y, Hattori N, Kawai K, et al. An ultrasonographic method for detection of Achilles tendon xanthomas in familial hypercholesterolemia. Atherosclerosis. 1989 Feb;75(2-3):211-8. doi: 10.1016/0021-9150(89)90178-0.

    PMID: 2653326BACKGROUND
  • Steinmetz A, Schmitt W, Schuler P, Kleinsorge F, Schneider J, Kaffarnik H. Ultrasonography of achilles tendons in primary hypercholesterolemia. Comparison with computed tomography. Atherosclerosis. 1988 Dec;74(3):231-9. doi: 10.1016/0021-9150(88)90242-0.

    PMID: 3071370BACKGROUND
  • Murugan A, Kanakaraju K, R M S, Sanjoy Mishra V. Achilles Tendon Softness and Thickness in Patients With Hypercholesterolemia. Cureus. 2022 Aug 24;14(8):e28340. doi: 10.7759/cureus.28340. eCollection 2022 Aug.

    PMID: 36168354BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, MD

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 10, 2025

Study Start

September 19, 2024

Primary Completion

October 19, 2024

Study Completion

October 20, 2024

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations