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Completed

NCT Number: NCT01628939

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

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.

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Key information

Conditions

Low Back Pain Back Pain Facet Joint Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH

Bochum, North Rhine-Westphalia, 44789, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI of the lumbar spine

Other

standard protocol, approximately 30 minutes

manual segmental examination of the lumbar facet joints

Other

use of three different segmental facet joint provocation tests (spinal palpation, segmental rotation and springing-test) from Th12-L1 to L5-S1

Primary outcomes

  1. 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 outcomes

  1. number of painful facet joints per person

    Time frame: 2 hours

    prevalence of facet joint pain assessed by manual segmental provocation tests

  2. 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)

Sponsors and collaborators

Lead sponsor

Christoph Maier, Prof. Dr.

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 27, 2012
Registry last updated
Jun 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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