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Association Between Clinical Signs and MRI Findings of the Lumbar Facet Joints

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01628939
First received: June 17, 2012
Last updated: June 24, 2012
Last verified: June 2012

June 17, 2012
June 24, 2012
June 2009
November 2009   (final data collection date for primary outcome measure)
Number of facet joints per person which show facet joint pain and FJ effusion and/ or edema [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
association of facet joint pain and MRI facet joint findings is determined
Same as current
Complete list of historical versions of study NCT01628939 on ClinicalTrials.gov Archive Site
  • number of painful facet joints per person [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    prevalence of facet joint pain assessed by manual segmental provocation tests
  • number of facet joints diagnosed with facet joint effusion and/ or edema per person [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    prevalence of facet joint findings in the lumbar spine assessed by MRI (facet joint effusion and/ or facet joint edema)
Same as current
Not Provided
Not Provided
 
Association Between Clinical Signs and MRI Findings of the Lumbar Facet Joints
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

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

pain clinic, sports clubs and fitness centers

  • Low Back Pain
  • Facet Joint Pain
  • Other: MRI of the lumbar spine
    standard protocol, approximately 30 minutes
  • Other: 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
  • 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)
    Interventions:
    • Other: MRI of the lumbar spine
    • Other: manual segmental examination of the lumbar facet joints
  • controls
    subjects with less than 30 days of low back pain in the last three months
    Interventions:
    • Other: MRI of the lumbar spine
    • Other: manual segmental examination of the lumbar facet joints
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01628939
FacetJointEdema2009
No
Christoph Maier, Prof. Dr., Ruhr University of Bochum
Christoph Maier, Prof. Dr.
Not Provided
Study Director: Christoph Maier, M.D., PhD Head of the Department of Pain medicine, BG Universitätsklinikum Bergmannsheil GmbH, 44789 Bochum, Germany
Ruhr University of Bochum
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP