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

June 24, 2012 updated by: Christoph Maier, Prof. Dr.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44789
        • Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pain clinic, sports clubs and fitness centers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of painful facet joints per person
Time Frame: 2 hours
prevalence of facet joint pain assessed by manual segmental provocation tests
2 hours
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)
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 17, 2012

First Submitted That Met QC Criteria

June 24, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Estimate)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 24, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FacetJointEdema2009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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