US and Shear Wave Elastography in Cubital Tunnel Syndrome

October 14, 2023 updated by: Eman Sayed Abdul Monem, Assiut University

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

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
US and shear wave elastography findings in diagnosis and grading of cubital tunnel syndrome
Time Frame: base line
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnosis and grading of cubital tunnel syndrome
Time Frame: base line
using electrodiagnostic studies as reference to reach cut off values for ulnar nerve cross sectional area and nerve stiffness
base line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

October 14, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US in cubital tunnel syndrome

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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