Clinical trial NCT06867211: Use of Ultrasonography for Measuring Achilles Tendon Thickness: a Novel Measurement Method
Official title: Use of Ultrasonography for Measuring Achilles Tendon Thickness: a Novel Measurement Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendon
Emergency Medicine
Ultrasonography
Keywords: achilles tendon
emergency medicine
ultrasonography
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: A novel ultrasonographic technique for achilles tendon thickness measurement
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya Training and Research Hospital
state: Adapazarı
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.