NCT01630382

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

11 months

First QC Date

June 26, 2012

Last Update Submit

June 27, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 28, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations