Achilles TendonNCT06867211
Use of Ultrasonography for Measuring Achilles Tendon Thickness: A Novel Measurement Method
An observational study of Achilles Tendon and Emergency Medicine, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendon, Emergency Medicine, Ultrasonography
- What is being tested?
- Use of Ultrasonography for Measuring Achilles Tendon Thickness
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2024to 20 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy volunteers aged >18 years who agreed to participate in the study
Who cannot join
- Individuals with tenosynovitis, tendinitis, bursitis, tuberculous arthritis, rheumatoid arthritis, a history of Achilles tendon surgery, or tendon injuries.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya Training and Research Hospital
Sakarya, Adapazarı, 54100
About this study
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.
- Conditions
- Achilles Tendon, Emergency Medicine, Ultrasonography
- Being tested
- Use of Ultrasonography for Measuring Achilles Tendon Thickness
- Keywords
- achilles tendon, emergency medicine, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Ultrasonography for Measuring Achilles Tendon ThicknessDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Use of Ultrasonography for Measuring Achilles Tendon Thickness | Not described Receives: Diagnostic Test: Use of Ultrasonography for Measuring Achilles Tendon Thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start19 Sep 2024
- Primary completion19 Oct 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Achilles TendonStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necip Gökhan Güner, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867211
- Sponsor's protocol ID
- 43012747-050.04-399468-15
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38807726Tharwat 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.
PubMed 38138284Silbernagel 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.
PubMed 27331037Del 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.
PubMed 28717629Yuzawa 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.
PubMed 2653326Steinmetz 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.
PubMed 3071370Murugan 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.
PubMed 36168354
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasonography for Measuring Achilles Tendon Thickness: A Novel Measurement Method
- ClinicalTrials.gov ID
- NCT06867211
- Acronym / sponsor ID
- 43012747-050.04-399468-15
- Conditions
- Achilles Tendon, Emergency Medicine, Ultrasonography
- Keywords
- achilles tendon, emergency medicine, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 19 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Ultrasonography for Measuring Achilles Tendon Thickness | – | Diagnostic Test: Use of Ultrasonography for Measuring Achilles Tendon Thickness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Healthy volunteers aged >18 years who agreed to participate in the study
Key exclusion criteria (1 listed)
- Individuals with tenosynovitis, tendinitis, bursitis, tuberculous arthritis, rheumatoid arthritis, a history of Achilles tendon surgery, or tendon injuries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Ultrasonography for Measuring Achilles Tendon ThicknessAchilles 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 | Diagnostic test | Use of Ultrasonography for Measuring Achilles Tendon Thickness |
Primary outcome
A novel ultrasonographic technique for achilles tendon thickness measurement
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Results publication: PubMed 38807726Sharifaskari 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.
- Results publication: PubMed 38138284Tharwat 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.
- Results publication: PubMed 27331037Silbernagel 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.
- Results publication: PubMed 28717629Del 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.
- Results publication: PubMed 2653326Yuzawa 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.
- Results publication: PubMed 3071370Steinmetz 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.
- Results publication: PubMed 36168354Murugan 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.
- Individual participant dataSharing planned: No
Related trials for Achilles Tendon
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Early Functional Outcomes After Open Versus Percutaneous Repair of Acute Achilles Tendon Ruptures
Patients With an Acute Achilles Tendon Rupture, Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks
Recruiting
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Achilles Tendon Rupture
Not yet recruitingObservational study
Open Versus Fully Endoscopic Calcaneoplasty With Achilles Tendon Insertional Reconstruction for Haglund Syndrome
Haglund Syndrome, Insertional Achilles Tendinopathy
Recruiting
Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
Achilles Insertional Tendinopathy, Achilles Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon and Emergency Medicine, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A novel ultrasonographic technique for achilles tendon thickness measurement (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867211, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.