NCT06090877

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 14, 2023

Last Update Submit

October 14, 2023

Conditions

Keywords

US+shear wave elstography+cubital tunnel syndrome

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

Also known as: electrodiagnostic studies and suitable operation

Eligibility Criteria

Age10 Years - 75 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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: 35328185BACKGROUND
  • 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.

    PMID: 35544306BACKGROUND
  • 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.

    PMID: 34054704BACKGROUND
  • 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.

    PMID: 33115185BACKGROUND
  • 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.

    PMID: 14759752BACKGROUND
  • 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.

    PMID: 25289024BACKGROUND

MeSH Terms

Conditions

Ulnar Nerve Compression Syndromes

Condition Hierarchy (Ancestors)

Ulnar NeuropathiesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Central Study Contacts

Eman Sayed, master

CONTACT

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