Low Back Pain Clinical Trial
Official title:
Association Between Clinical Signs Assessed by Manual Segmental Examination and Findings of the Lumbar Facet Joints in Magnetic-resonance Scans in Subjects With and Without Current Low Back - a Prospective Single-blinded Study
Verified date | June 2012 |
Source | Ruhr University of Bochum |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH | Bochum | NRW |
Lead Sponsor | Collaborator |
---|---|
Christoph Maier, Prof. Dr. |
Germany,
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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