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EMG Finding According to the Type of Lumbar Disc Herniation

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ClinicalTrials.gov Identifier: NCT04538807
Recruitment Status : Recruiting
First Posted : September 4, 2020
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Dong Gyu Lee, Yeungnam University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Intervertebral Disc Displacement Electromyography Diagnostic Test: electromyography

Study Design
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Study Type : Observational
Estimated Enrollment : 74 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Study for Electrodiagnostic Finding According to the Type of Lumbar Disc Herniation on MRI
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Lumbar disc herniation
Patients are complaining of lower extremity radiating pain due to lumbar disc herniation.
 Diagnostic Test: electromyography
Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.


Outcome Measures
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Primary Outcome Measures :
  1. Denervation pattern of muscles in lower extremity [ Time Frame: 1 day During the examination of Electromyogram ]
    The location of the lower limb muscles where spontaneous activity occurs


Secondary Outcome Measures :
  1. Disc herniation findings of lumbar MRI [ Time Frame: 1 day During the examination of lumbar MRI ]
    Anatomical location of disc herniation


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary referral hospital
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.)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04538807


Locations
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Korea, Republic of
Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of, 42415
Contact: Dong gyu Lee, M.D., Ph.D.    82536203829    painfree@yu.ac.kr   
Sponsors and Collaborators
Yeungnam University Hospital
More Information
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Responsible Party: Dong Gyu Lee, Assistant professor, Yeungnam University Hospital
ClinicalTrials.gov Identifier: NCT04538807    
Other Study ID Numbers: 2020-07-005-001
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Hernia
Pathological Conditions, Anatomical
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases