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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628939
• Other study ID #: FacetJointEdema2009
• Status: Completed
• Phase: N/A
• First received: June 17, 2012
• Last updated: June 24, 2012
• Start date: June 2009
• Est. completion date: November 2009

Study information

• Verified date: June 2012
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthralgia
• Facet Joint Pain
• Low Back Pain

Intervention

Other:
• MRI of the lumbar spine
standard protocol, approximately 30 minutes
• 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

Locations

Country	Name	City	State
Germany	Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH	Bochum	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Christoph Maier, Prof. Dr.

Country where clinical trial is conducted

Germany, 

Outcome

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