Cervical Myelopathy SpondylosisLBPNCT03089931
Change of Lumbar Symptom After Surgical Treatment for Patients With Cervical Stenosis
An observational study of Cervical Myelopathy Spondylosis and Low Back Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Low back pain may be reduced after cervical spinal surgery Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cervical Myelopathy Spondylosis, Low Back Pain
- What is being tested?
- Cervical spinal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2012to 15 Oct 2020
- How long will I take part?
- 6 Months
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with cervical myelopathy and low back pain
Who may be able to join
- all patients with cervical myelopathy and low back pain
Who cannot join
- previous surgery at the lumbar spine
- malignancy
- previous surgery at the cervical spine
Trial locations and contacts
1 site in 1 country.
About this study
Low back pain may be reduced after cervical spinal surgery
Read the detailed description
The improved back pain score after cervical spinal surgery would be higher than that after non-surgical treatment.
- Conditions
- Cervical Myelopathy Spondylosis, Low Back Pain
- Being tested
- Cervical spinal surgery
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical spinal surgeryProcedure or surgery
Cervical laminoplasty or anterior discectomy and fusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain
improve visual analogue pain score (VAS) more than 1.2/10
Measured: postoperative 6 months
functional outcome
improve Oswestry diability index (ODI) more than 6.2/45
Measured: postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start11 Nov 2012
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Myelopathy SpondylosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Heon Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089931
- Sponsor's protocol ID
- CSMLBP
- Acronym
- LBP
- Status last verified
- Oct 2020
- First submitted
- 15 Mar 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Lumbar Symptom After Surgical Treatment for Patients With Cervical Stenosis
- ClinicalTrials.gov ID
- NCT03089931
- Acronym / sponsor ID
- LBP / CSMLBP
- Conditions
- Cervical Myelopathy Spondylosis, Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 11 Nov 2012 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 24 Mar 2017 (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.
Low back pain may be reduced after cervical spinal surgery
Detailed description
The improved back pain score after cervical spinal surgery would be higher than that after non-surgical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with cervical myelopathy and low back pain
Key inclusion criteria (1 listed)
- all patients with cervical myelopathy and low back pain
Key exclusion criteria (3 listed)
- previous surgery at the lumbar spine
- malignancy
- previous surgery at the cervical spine
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 |
|---|---|---|
| Cervical spinal surgeryCervical laminoplasty or anterior discectomy and fusion | Procedure or surgery | – |
Primary outcome
Low back pain
Time frame: postoperative 6 months
improve visual analogue pain score (VAS) more than 1.2/10
functional outcome
Time frame: postoperative 6 months
improve Oswestry diability index (ODI) more than 6.2/45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Cervical Myelopathy Spondylosis
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cervical Myelopathy Spondylosis and Low Back Pain, run by Seoul National 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 22 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain (time frame: postoperative 6 months). The study lists 2 primary outcomes in all. 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 22 Oct 2020.