NCT04538807

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 21, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

August 21, 2020

Last Update Submit

August 30, 2021

Conditions

Intervertebral Disc DisplacementElectromyography

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Disc herniation findings of lumbar MRI

    1 day During the examination of lumbar MRI

Study Arms (1)

Lumbar disc herniation

Patients are complaining of lower extremity radiating pain due to lumbar disc herniation.

Diagnostic Test: electromyography

Interventions

electromyographyDIAGNOSTIC_TEST

Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.

Lumbar disc herniation

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary referral hospital

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeungnam University Hospital

Daegu, 42415, South Korea

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 21, 2020

First Posted

September 4, 2020

Study Start

September 10, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)