Clinical trial NCT06090877: US and Shear Wave Elastography in Cubital Tunnel Syndrome
Official title: Role of Ultrasound and Shear Wave Elastography in Diagnosis and Grading of Cubital Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ulnar Nerve Compression
Keywords: US+shear wave elstography+cubital tunnel syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient preparation:

• No specific preparations needed. 2. Study instruments:- All patients will undergo B-mode ultrasound and SWE using GE Logiq S8 ultrasound machine with 9L-D Linear Array Transducer, at the Radiology Department of Assiut University Hospital, Assuit University.

Brief 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)

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: US and shear wave elastography findings in diagnosis and grading of cubital tunnel syndrome
timeFrame: base line
Secondary outcomes:
measure: diagnosis and grading of cubital tunnel syndrome
timeFrame: base line
Other outcomes:
Locations:
Study officials:
References:
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