Cerebrospinal Fluid Congestion in Spinal Stenosis Patients | NCT01630382

Studies
Cerebrospinal Fluid Congestion in Spinal Stenosis Patients

NCT01630382

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jun 28, 2012Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Spinal Stenosis

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

May 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jun 26, 2012

First Submission Date that Met QC Criteria

Jun 27, 2012

First Posted Date

Jun 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2012

Last Update Posted Date

Jun 28, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal fluid congestion.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CSF pressure at spinal canal	We can calculate CSF pressure at spinal canal by using phase contraast magnetic resonance image technique.	on time of recruitment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

neurogenic claudication more than 3months
relief neurogenic claudication by lumbar flexion
spinal stenosis symptom by physical exam.
who can walk more than 30 min.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

study group : spinal stenosis patient control group : matched sex, age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013130	Spinal Stenosis

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided