US and Shear Wave Elastography in Cubital Tunnel Syndrome

Ulnar Nerve Compression Clinical Trial

Official title:

Role of Ultrasound and Shear Wave Elastography in Diagnosis and Grading of Cubital Tunnel Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06090877
• Other study ID #: US in cubital tunnel syndrome
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Eman Sayed, master
• Phone: 01019870725
• Email: eman11486[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to assess the role of US and SWE in diagnosis of CuTS and localization of its underlying etiology and verifying whether it can be diagnosed and graded based on US findings, especially quantitaive ulnar nerve stiffness data obtained using SWE, compared to ENMG and intraoperative findings (as gold standard)

Description:

Ulnar nerve (UN) entrapment at the elbow is the second most frequent tunnel syndrome, following carpal tunnel syndrome. Cubital tunnel syndrome (CuTS) is a common nerve entrapment syndrome of the upper extremity, caused by compression of the ulnar nerve at the cubital tunnel of the elbow. The presentation of cubital tunnel syndrome varies, ranging from mild sensory symptoms to debilitating functional loss. Typical CuTS symptoms include numbness, tingling, and dysesthesia in the ring, small finger and dorsum of the hand. As the disease progresses, atrophy of the hypothenar and first dorsal interosseous muscles occurs, which may interfere with daily activities. CuTS is likelier to be at an advanced stage at the time of intervention than carpal tunnel syndrome (CTS). Therefore, early diagnosis and treatment are important. Also, due to anatomic variations, a broad spectrum of differential diagnosis, and miscellaneous clinical presentations, the clinical diagnosis is often far from straightforward. If not treated timely and adequately, CuTS can progress to persistent impairment of sensation, paresis, and joint contracture. This condition is typically diagnosed using patient's history, physical examination, and electrodiagnostic studies. However, because CuTS has a variety of clinical characteristics, it is difficult to differentiate it from other diseases that can affect the elbow joint based on clinical presentation and an electrodiagnostic study. Electroneuromyography (ENMG) is the gold standard examination in CuTS, but sheds no light on etiology. Although an electrodiagnostic study is considered the most important diagnostic test for CuTS, it has some critical drawbacks. It is time-consuming, causing pain and injury to patients due to needle insertion and electrical stimulation, provides limited information regarding lesion localization and structural abnormalities, and carries a strong possibility of false negative results. Thus, complementary imaging studies such as magnetic resonance or high resolution ultrasound (HRU) imaging are required for the diagnosis of various neuropathies. Ultrasound imaging in particular supports the diagnosis of neuropathy by providing superior spatial resolution of small peripheral nerves, allowing for dynamic evaluation and detailed information regarding lesion localization in addition to advantages of being fast, cheap, non invasive and painless procedure. Moreover, as a recently-developed ultrasound imaging technology, shear-wave elastography (SWE) has the potential to provide quantitative values for the soft tissue stiffness of tissues, including the muscle, tendon, joint capsule, benign soft tissue mass, and nerves, and to improve the diagnostic performance of ultrasound imaging for various nerve neuropathies. SWE is also an advanced quantitative ultrasound technique that can be used to evaluate soft tissue elasticity. In compressive neuropathy, a higher pressure within the canal could cause ischemia, edema, inflammation, and finally fibrosis in the intraneural space and the synovium. All of these changes to the compressed nerve may result in increased nerve stiffness. Therefore, SWE could be a valuable complement in the diagnosis of compressive neuropathy. So, SWE seems to be a new, reliable, and simple quantitative diagnostic technique to aid in the precise diagnosis of ulnar neuropathy at the cubital tunnel, and HRU proved to be an effective diagnostic tool for CuTS and its etiologies

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 1, 2025
• Est. primary completion date: November 1, 2024
• Gender: All
• Age group: 10 Years to 75 Years

Eligibility

Inclusion Criteria:

• In this study patients referred from the orthopedic clinic with a clinical diagnosis of clinical cubital tunnel syndrome and having electrodiagnostic studies will be included

Exclusion Criteria:

• Lack of electrodiagnostic studies.
• Refuse to do surgery when indicated

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome
• Ulnar Nerve Compression

Intervention

Device:
• US and shear wave elstography
using B mode US to assess ulnar nerve echogenicity, measuring its cross sectional area and assess any other anatomical abnormalites Measuring ulnar nerve stiffness using shear wave elastography All measurements done at the cubital tunnel, 2 cm proximal and distal to it compare findings with electrodiagnostic studies and intra operative findings

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Kim S, Lee GY. Evaluation of the ulnar nerve with shear-wave elastography: a potential sonographic method for the diagnosis of ulnar neuropathy. Ultrasonography. 2021 Jul;40(3):349-356. doi: 10.14366/usg.20101. Epub 2020 Aug 23. — View Citation

Mezian K, Jacisko J, Kaiser R, Machac S, Steyerova P, Sobotova K, Angerova Y, Nanka O. Ulnar Neuropathy at the Elbow: From Ultrasound Scanning to Treatment. Front Neurol. 2021 May 14;12:661441. doi: 10.3389/fneur.2021.661441. eCollection 2021. — View Citation

Power HA, Peters BR, Patterson JMM, Padovano WM, Mackinnon SE. Classifying the Severity of Cubital Tunnel Syndrome: A Preoperative Grading System Incorporating Electrodiagnostic Parameters. Plast Reconstr Surg. 2022 Jul 1;150(1):115e-126e. doi: 10.1097/PRS.0000000000009255. Epub 2022 May 10. — View Citation

Qing C, Zhang J, Wu S, Ling Z, Wang S, Li H, Li H. Clinical classification and treatment of cubital tunnel syndrome. Exp Ther Med. 2014 Nov;8(5):1365-1370. doi: 10.3892/etm.2014.1983. Epub 2014 Sep 22. — View Citation

Rempel DM, Diao E. Entrapment neuropathies: pathophysiology and pathogenesis. J Electromyogr Kinesiol. 2004 Feb;14(1):71-5. doi: 10.1016/j.jelekin.2003.09.009. — View Citation

Shinohara I, Inui A, Mifune Y, Nishimoto H, Yamaura K, Mukohara S, Yoshikawa T, Kato T, Furukawa T, Hoshino Y, Matsushita T, Kuroda R. Diagnosis of Cubital Tunnel Syndrome Using Deep Learning on Ultrasonographic Images. Diagnostics (Basel). 2022 Mar 4;12(3):632. doi: 10.3390/diagnostics12030632. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	US and shear wave elastography findings in diagnosis and grading of cubital tunnel syndrome	measuring cross sectional area and nerve stiffness of the ulnar nerve at cubital tunnel and 2 cm proximal and distal to it as well detection of any anatomical abnormalities, assessing ulnar nerve instability Then findings of US and shear wave elastography will be compared with clinical, electrodiagnostic studies results and intra oprative findings.	base line
Secondary	diagnosis and grading of cubital tunnel syndrome	using electrodiagnostic studies as reference to reach cut off values for ulnar nerve cross sectional area and nerve stiffness	base line