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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628939
First Posted: June 27, 2012
Last Update Posted: June 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum
  Purpose

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.


Condition Intervention
Low Back Pain Facet Joint Pain Other: MRI of the lumbar spine Other: manual segmental examination of the lumbar facet joints

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Christoph Maier, Prof. Dr., Ruhr University of Bochum:

Primary Outcome Measures:
  • Number of facet joints per person which show facet joint pain and FJ effusion and/ or edema [ Time Frame: 2 hours ]
    association of facet joint pain and MRI facet joint findings is determined


Secondary Outcome Measures:
  • number of painful facet joints per person [ Time Frame: 2 hours ]
    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 ]
    prevalence of facet joint findings in the lumbar spine assessed by MRI (facet joint effusion and/ or facet joint edema)


Enrollment: 150
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
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
controls
subjects with less than 30 days of low back pain in the last three months
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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
pain clinic, sports clubs and fitness centers
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628939


Locations
Germany
Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
Bochum, NRW, Germany, 44789
Sponsors and Collaborators
Christoph Maier, Prof. Dr.
Investigators
Study Director: Christoph Maier, M.D., PhD Head of the Department of Pain medicine, BG Universitätsklinikum Bergmannsheil GmbH, 44789 Bochum, Germany
  More Information

Responsible Party: Christoph Maier, Prof. Dr., Prof. Dr. med., Head of the Department of Pain medicine, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01628939     History of Changes
Other Study ID Numbers: FacetJointEdema2009
First Submitted: June 17, 2012
First Posted: June 27, 2012
Last Update Posted: June 27, 2012
Last Verified: June 2012

Keywords provided by Christoph Maier, Prof. Dr., Ruhr University of Bochum:
low back pain
facet joint pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Arthralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases