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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01628939
Other study ID # FacetJointEdema2009
Secondary ID
Status Completed
Phase N/A
First received June 17, 2012
Last updated June 24, 2012
Start date June 2009
Est. completion date November 2009

Study information

Verified date June 2012
Source Ruhr University of Bochum
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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

in subjects with current low back pain and in a control group.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria for both study groups:

- age > 18

- written informed consent

- ability to perform required examinations

Inclusion Criterion for current low back pain-group:

- more than (>=) 30 days of low back pain in the last three months

Inclusion Criterion for control group:

- less than 30 days of low back pain in the last three months

Exclusion Criteria for both study groups:

- acute radicular low back pain in the last three months

- claustrophobia

- spondylodesis of the lumbar spine

- any metallic implants which are not MRI-compatible

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
MRI of the lumbar spine
standard protocol, approximately 30 minutes
manual segmental examination of the lumbar facet joints
use of three different segmental facet joint provocation tests (spinal palpation, segmental rotation and springing-test) from Th12-L1 to L5-S1

Locations

Country Name City State
Germany Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH Bochum NRW

Sponsors (1)

Lead Sponsor Collaborator
Christoph Maier, Prof. Dr.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary number of painful facet joints per person prevalence of facet joint pain assessed by manual segmental provocation tests 2 hours No
Secondary number of facet joints diagnosed with facet joint effusion and/ or edema per person prevalence of facet joint findings in the lumbar spine assessed by MRI (facet joint effusion and/ or facet joint edema) 2 hours No
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