US and Shear Wave Elastography in Cubital Tunnel Syndrome
Role of Ultrasound and Shear Wave Elastography in Diagnosis and Grading of Cubital Tunnel Syndrome
1 other identifier
observational
50
0 countries
N/A
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedOctober 19, 2023
October 1, 2023
1 year
October 14, 2023
October 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
diagnosis and grading of cubital tunnel syndrome
base line
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Lack of electrodiagnostic studies.
- Refuse to do surgery when indicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
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.
PMID: 35328185BACKGROUNDPower 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.
PMID: 35544306BACKGROUNDMezian 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.
PMID: 34054704BACKGROUNDKim 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.
PMID: 33115185BACKGROUNDRempel 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.
PMID: 14759752BACKGROUNDQing 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.
PMID: 25289024BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr
Study Record Dates
First Submitted
October 14, 2023
First Posted
October 19, 2023
Study Start
November 1, 2023
Primary Completion
November 1, 2024
Study Completion
June 1, 2025
Last Updated
October 19, 2023
Record last verified: 2023-10