Intervertebral Disc DisplacementNCT04538807
EMG Finding According to the Type of Lumbar Disc Herniation
An observational study of Intervertebral Disc Displacement and Electromyography, run by Yeungnam University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Intervertebral Disc Displacement, Electromyography
- What is being tested?
- electromyography
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Sep 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary referral hospital
Who may be able to join
- Radicular pain within 6 months
- Disc herniation confirmed by lumbar MRI
- undergoing electromyography
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yeungnam University Hospital
Daegu, 42415
Dong gyu Lee, M.D., Ph.D., 82536203829, painfree@yu.ac.kr
About this study
Official title: A Study for Electrodiagnostic Finding According to the Type of Lumbar Disc Herniation on MRI
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.
- Conditions
- Intervertebral Disc Displacement, Electromyography
- Being tested
- electromyography
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromyographyDiagnostic test
Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar disc herniation | Patients are complaining of lower extremity radiating pain due to lumbar disc herniation. Receives: Diagnostic Test: electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Denervation pattern of muscles in lower extremity
The location of the lower limb muscles where spontaneous activity occurs
Measured: 1 day During the examination of Electromyogram
Secondary outcomes (1)
Disc herniation findings of lumbar MRI
Anatomical location of disc herniation
Measured: 1 day During the examination of lumbar MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start10 Sep 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DisplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Gyu Lee, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538807
- Sponsor's protocol ID
- 2020-07-005-001
- Status last verified
- Aug 2021
- First submitted
- 21 Aug 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for Electrodiagnostic Finding According to the Type of Lumbar Disc Herniation on MRI
- ClinicalTrials.gov ID
- NCT04538807
- Acronym / sponsor ID
- 2020-07-005-001
- Conditions
- Intervertebral Disc Displacement, Electromyography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Yeungnam University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar disc herniation | – | Diagnostic Test: electromyographyPatients are complaining of lower extremity radiating pain due to lumbar disc herniation. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary referral hospital
Key inclusion criteria (3 listed)
- Radicular pain within 6 months
- Disc herniation confirmed by lumbar MRI
- undergoing electromyography
Key exclusion criteria (6 listed)
- Patients who refused electromyography
- Patients taking warfarin
- Lower limb amputation patient
- Pregnant women
- Patients who have undergone surgical treatment for disc herniation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electromyographyElectromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles. | Diagnostic test | Lumbar disc herniation |
Primary outcome
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
1 secondary outcome
Disc herniation findings of lumbar MRI
Time frame: 1 day During the examination of lumbar MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Displacement and Electromyography, run by Yeungnam University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Denervation pattern of muscles in lower extremity (time frame: 1 day During the examination of Electromyogram). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.