- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06867211
Use of Ultrasonography for Measuring Achilles Tendon Thickness: a Novel Measurement Method
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Adapazarı
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Sakarya, Adapazarı, Turkey, 54100
- Sakarya Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy volunteers aged >18 years who agreed to participate in the study
Exclusion Criteria:
- Individuals with tenosynovitis, tendinitis, bursitis, tuberculous arthritis, rheumatoid arthritis, a history of Achilles tendon surgery, or tendon injuries.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Use of Ultrasonography for Measuring Achilles Tendon Thickness
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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A novel ultrasonographic technique for achilles tendon thickness measurement
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43012747-050.04-399468-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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