Association Between Clinical Signs and MRI Findings of the Lumbar Facet Joints
1 other identifier
observational
150
1 country
1
Brief Summary
The purpose of this study is to determine
- 1.the prevalence of lumbar facet joint pain detected by manual segmental provocation tests
- 2.the prevalence of MRI findings of the lumbar facet joints (hypertrophy, effusion, edema)
- 3.the association of lumbar facet joint pain and MRI findings on a segmental level
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 17, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedJune 27, 2012
June 1, 2012
5 months
June 17, 2012
June 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of facet joints per person which show facet joint pain and FJ effusion and/ or edema
association of facet joint pain and MRI facet joint findings is determined
2 hours
Secondary Outcomes (2)
number of painful facet joints per person
2 hours
number of facet joints diagnosed with facet joint effusion and/ or edema per person
2 hours
Study Arms (2)
current low back pain
subjects with current low back pain (i.e. more than 30 days of low back pain in the last three months)
controls
subjects with less than 30 days of low back pain in the last three months
Interventions
standard protocol, approximately 30 minutes
use of three different segmental facet joint provocation tests (spinal palpation, segmental rotation and springing-test) from Th12-L1 to L5-S1
Eligibility Criteria
pain clinic, sports clubs and fitness centers
You may qualify if:
- age \> 18
- written informed consent
- ability to perform required examinations
- \- more than (\>=) 30 days of low back pain in the last three months
- \- less than 30 days of low back pain in the last three months
You may not qualify if:
- acute radicular low back pain in the last three months
- claustrophobia
- spondylodesis of the lumbar spine
- any metallic implants which are not MRI-compatible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
Bochum, North Rhine-Westphalia, 44789, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christoph Maier, M.D., PhD
Head of the Department of Pain medicine, BG Universitätsklinikum Bergmannsheil GmbH, 44789 Bochum, Germany
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. med., Head of the Department of Pain medicine
Study Record Dates
First Submitted
June 17, 2012
First Posted
June 27, 2012
Study Start
June 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
June 27, 2012
Record last verified: 2012-06