- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03089931
Change of Lumbar Symptom After Surgical Treatment for Patients With Cervical Stenosis (LBP)
October 20, 2020 updated by: Chi Heon Kim, Seoul National University Hospital
Low back pain may be reduced after cervical spinal surgery
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The improved back pain score after cervical spinal surgery would be higher than that after non-surgical treatment.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Korea
-
Seoul, Korea, Korea, Republic of, 03080
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with cervical myelopathy and low back pain
Description
Inclusion Criteria:
- all patients with cervical myelopathy and low back pain
Exclusion Criteria:
- previous surgery at the lumbar spine
- malignancy
- previous surgery at the cervical spine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low back pain
Time Frame: postoperative 6 months
|
improve visual analogue pain score (VAS) more than 1.2/10
|
postoperative 6 months
|
functional outcome
Time Frame: postoperative 6 months
|
improve Oswestry diability index (ODI) more than 6.2/45
|
postoperative 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2012
Primary Completion (Actual)
October 15, 2020
Study Completion (Actual)
October 15, 2020
Study Registration Dates
First Submitted
March 15, 2017
First Submitted That Met QC Criteria
March 20, 2017
First Posted (Actual)
March 24, 2017
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSMLBP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Cervical spinal surgery
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Bezmialem Vakif UniversityWithdrawnCervical Disc Disease | Cervical Spine DiseaseTurkey
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Hacettepe UniversityBElibol; NKöse; GYÇakmaklı; SAksoy; RGöçmenCompletedParkinson DiseaseTurkey
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Canadian Memorial Chiropractic CollegeUniversity of GuelphCompletedMyofascial Pain Syndrome | Myofascial Trigger Points | Trigger Points, MyofascialCanada
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Shanghai Changzheng HospitalRecruitingMyelopathy CervicalChina
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K2M, Inc.Recruiting
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University Hospital, Clermont-FerrandUnknownCachexia | Cancer of Upper Aerodigestive PathwaysFrance
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University of LouisvilleWithdrawnSpinal Cord InjuriesUnited States
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Charitable Foundation Children with Spinal Muscular...WithdrawnSpinal Muscular Atrophy | Neuromuscular DisordersUkraine
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Assiut UniversityNot yet recruiting