Spinal StenosisNCT01630382
Cerebrospinal Fluid Congestion in Spinal Stenosis Patients
An observational study of Spinal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal fluid congestion. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Stenosis
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Dec 2013
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: study group : spinal stenosis patient control group : matched sex, age
Who may be able to join
- neurogenic claudication more than 3months
- relief neurogenic claudication by lumbar flexion
- spinal stenosis symptom by physical exam.
- who can walk more than 30 min.
Who cannot join
- vascular claudication by physical exam.( ABI <0.9)
- structural change in vertebral ( tumor, congenital deformity)
- operation history at spinal bone
- metallic foreign body
- peripheral polyneuropathy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul
Keewon Kim, +82-2-2072-2619, kdkdkd1@hanmail.net
About this study
The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal fluid congestion.
- Conditions
- Spinal Stenosis
- Medical subject headings
- Spinal Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF pressure at spinal canal
We can calculate CSF pressure at spinal canal by using phase contraast magnetic resonance image technique.
Measured: on time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630382
- Sponsor's protocol ID
- H-1203-088-402
- Status last verified
- Jun 2012
- First submitted
- 26 Jun 2012
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Congestion in Spinal Stenosis Patients
- ClinicalTrials.gov ID
- NCT01630382
- Acronym / sponsor ID
- H-1203-088-402
- Conditions
- Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 28 Jun 2012 (estimated)
- 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.
The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal fluid congestion.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- study group : spinal stenosis patient control group : matched sex, age
Key inclusion criteria (4 listed)
- neurogenic claudication more than 3months
- relief neurogenic claudication by lumbar flexion
- spinal stenosis symptom by physical exam.
- who can walk more than 30 min.
Key exclusion criteria (5 listed)
- vascular claudication by physical exam.( ABI <0.9)
- structural change in vertebral ( tumor, congenital deformity)
- operation history at spinal bone
- metallic foreign body
- peripheral polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CSF pressure at spinal canal
Time frame: on time of recruitment
We can calculate CSF pressure at spinal canal by using phase contraast magnetic resonance image technique.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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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 Spinal Stenosis, 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 4 inclusion and 5 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 28 Jun 2012. 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?
CSF pressure at spinal canal (time frame: on time of recruitment). 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 28 Jun 2012.