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
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ 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)


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 17, 2012
Last Updated: June 24, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on October 02, 2014