Role of Ultrasonography in the Diagnosis of Carpal Tunnel... | NCT04976998

Studies
Role of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome

NCT04976998

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Aug 17, 2021Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Carpal Tunnel Syndrome

Interventions

imaging

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2021Estimated

Primary Completion Date

Feb 2, 2022Estimated

Completion Date

Mar 20, 2022Estimated

First Submitted Date

Jul 15, 2021

First Submission Date that Met QC Criteria

Jul 15, 2021

First Posted Date

Jul 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2021

Last Update Posted Date

Aug 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective study aims to evaluate the median nerve in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies.

Detailed Description

This prospective study aims to evaluate the median nerve anatomical changes in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies physiological changes to determine the efficacy of ultrasound to diagnose and determine the severity of carpal tunnel syndrome.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients		those with symptoms of CTS	Diagnostic Test: imaging
control group		normal people those with no symptoms of CTS	Diagnostic Test: imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
imaging	Diagnostic Test	imaging by ultrasonography and nerve conduction studies will be done for both grups	control group patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
anatomical changes in the median nerve in carpal tunnel syndrome	compare the anatomical changes observed by ultrasonography in patients diagnosed with carpal tunnel syndrome and comparing the results with clinical and nerve conduction studies results	imaging within 24 hours from the nerve conduction studies and clinical assessment of the patient

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any Age Group with symptoms, clinical signs and NCS consistent with CTS

Exclusion Criteria:

Uncooperative Patients .
Patients with History of previous wrist surgery, fracture or traumatic nerve injury

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

sohag university hospital patients and attendants

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mostafa mm Mohamed, MBBCh	Contact	01095529721	+20	mostafa011187@med.sohag.edu.eg

Overall Officials

Name	Affiliation	Role
mostafa mm mohamed, MBBCH	Sohag University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University - Faculty of Medicine	Recruiting	Sohag		82524	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 11, 2023
Reset	Feb 23, 2024

Submission Tracking

Estimated Results First Submitted Date

Jul 11, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 11, 2023			Feb 23, 2024

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003952	Diagnostic Imaging
D000092184	Nerve Conduction Studies

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D003943	Diagnostic Techniques, Neurological
D004568	Electrodiagnosis

Browse Leaves

Not provided

Browse Branches

Not provided