NCT01628939

Brief Summary

The purpose of this study is to determine

  1. 1.the prevalence of lumbar facet joint pain detected by manual segmental provocation tests
  2. 2.the prevalence of MRI findings of the lumbar facet joints (hypertrophy, effusion, edema)
  3. 3.the association of lumbar facet joint pain and MRI findings on a segmental level

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
Last Updated

June 27, 2012

Status Verified

June 1, 2012

Enrollment Period

5 months

First QC Date

June 17, 2012

Last Update Submit

June 24, 2012

Conditions

Keywords

low back painfacet joint pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • number of painful facet joints per person

    2 hours

  • number of facet joints diagnosed with facet joint effusion and/ or edema per person

    2 hours

Study Arms (2)

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 spineOther: manual segmental examination of the lumbar facet joints

controls

subjects with less than 30 days of low back pain in the last three months

Other: MRI of the lumbar spineOther: manual segmental examination of the lumbar facet joints

Interventions

standard protocol, approximately 30 minutes

controlscurrent low back pain

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

controlscurrent low back pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pain clinic, sports clubs and fitness centers

You may qualify if:

  • age \> 18
  • written informed consent
  • ability to perform required examinations
  • \- more than (\>=) 30 days of low back pain in the last three months
  • \- less than 30 days of low back pain in the last three months

You may not qualify if:

  • acute radicular low back pain in the last three months
  • claustrophobia
  • spondylodesis of the lumbar spine
  • any metallic implants which are not MRI-compatible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH

Bochum, North Rhine-Westphalia, 44789, Germany

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Maier, M.D., PhD

    Head of the Department of Pain medicine, BG Universitätsklinikum Bergmannsheil GmbH, 44789 Bochum, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med., Head of the Department of Pain medicine

Study Record Dates

First Submitted

June 17, 2012

First Posted

June 27, 2012

Study Start

June 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

June 27, 2012

Record last verified: 2012-06

Locations