EMG Finding According to the Type of Lumbar Disc Herniation | NCT04538807

Studies
EMG Finding According to the Type of Lumbar Disc Herniation

NCT04538807

Sponsor

Yeungnam University Hospital

Status

Unknown status

Last Update Posted

Aug 31, 2021Actual

Enrollment

74Estimated

Phase

Not provided

Conditions

Intervertebral Disc Displacement
Electromyography

Interventions

electromyography

Countries

South Korea

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

No data available

No data is available for this block.

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

Sep 10, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Aug 21, 2020

First Submission Date that Met QC Criteria

Sep 3, 2020

First Posted Date

Sep 4, 2020Actual

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 30, 2021

Last Update Posted Date

Aug 31, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dong Gyu Lee, Assistant professor, Yeungnam University HospitalPrincipal Investigator

Lead Sponsor

Yeungnam University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Disc herniation is a common cause of low back pain and leg pain. Electromyography is the only test that can objectively examine nerve damage caused by a lumbar disc herniation. This study aimed to compare the MRI findings of disc herniation and the aspects of electromyography.

Detailed Description

Not provided

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

74Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lumbar disc herniation		Patients are complaining of lower extremity radiating pain due to lumbar disc herniation.	Diagnostic Test: electromyography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electromyography	Diagnostic Test	Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Denervation pattern of muscles in lower extremity	The location of the lower limb muscles where spontaneous activity occurs	1 day During the examination of Electromyogram

Secondary Outcomes

Measure	Description	Time Frame
Disc herniation findings of lumbar MRI	Anatomical location of disc herniation	1 day During the examination of lumbar MRI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Radicular pain within 6 months
Disc herniation confirmed by lumbar MRI
undergoing electromyography

Exclusion Criteria:

Patients who refused electromyography
Patients taking warfarin
Lower limb amputation patient
Pregnant women
Patients who have undergone surgical treatment for disc herniation
Patients with peripheral neuropathy ( AIDP, CIDP, diabetic amyotrophy, peroneal pals et al.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Tertiary referral hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yeungnam University Hospital	Recruiting	Daegu		42415	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007405	Intervertebral Disc Displacement

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006547	Hernia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004576	Electromyography

Ancestor Terms

ID	Term
D004568	Electrodiagnosis
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D009213	Myography

Browse Leaves

Not provided

Browse Branches

Not provided