Association Between Clinical Signs and MRI Findings of the Lumbar Facet Joints
This study has been completed.
Sponsor:
Christoph Maier, Prof. Dr.
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
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Purpose
The purpose of this study is to determine
- the prevalence of lumbar facet joint pain detected by manual segmental provocation tests
- the prevalence of MRI findings of the lumbar facet joints (hypertrophy, effusion, edema)
- 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
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:
|
Arthralgia Back Pain Low Back Pain Signs and Symptoms Joint Diseases |
Musculoskeletal Diseases Pain Neurologic Manifestations Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013