Low Back PainNCT01628939
Association Between Clinical Signs and MRI Findings of the Lumbar Facet Joints
An observational study of Low Back Pain and Facet Joint Pain, run by Christoph Maier, Prof. Dr. at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Facet Joint Pain
- What is being tested?
- MRI of the lumbar spine and manual segmental examination of the lumbar facet joints
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: pain clinic, sports clubs and fitness centers
Who may be able to join
- 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
Who cannot join
- acute radicular low back pain in the last three months
- claustrophobia
- spondylodesis of the lumbar spine
- any metallic implants which are not MRI-compatible
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
Bochum, North Rhine-Westphalia, 44789
About this study
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
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.
- Conditions
- Low Back Pain, Facet Joint Pain
- Being tested
- MRI of the lumbar spine, manual segmental examination of the lumbar facet joints
- Keywords
- low back pain, facet joint pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI of the lumbar spineOther
standard protocol, approximately 30 minutes
manual segmental examination of the lumbar facet jointsOther
use of three different segmental facet joint provocation tests (spinal palpation, segmental rotation and springing-test) from Th12-L1 to L5-S1
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: MRI of the lumbar spine; Other: manual segmental examination of the lumbar facet joints | |
| controls | subjects with less than 30 days of low back pain in the last three months Receives: Other: MRI of the lumbar spine; Other: manual segmental examination of the lumbar facet joints |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (2)
number of painful facet joints per person
prevalence of facet joint pain assessed by manual segmental provocation tests
Measured: 2 hours
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)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph Maier, Prof. Dr.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
- Investigators
- Christoph Maier, M.D., PhD, Study director, Head of the Department of Pain medicine, BG Universitätsklinikum Bergmannsheil GmbH, 44789 Bochum, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628939
- Sponsor's protocol ID
- FacetJointEdema2009
- Status last verified
- Jun 2012
- First submitted
- 17 Jun 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01628939
- Acronym / sponsor ID
- FacetJointEdema2009
- Conditions
- Low Back Pain, Facet Joint Pain
- Keywords
- low back pain, facet joint pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Christoph Maier, Prof. Dr.University, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| current low back pain | – | Other: MRI of the lumbar spine, Other: manual segmental examination of the lumbar facet jointssubjects with current low back pain (i.e. more than 30 days of low back pain in the last three months) |
| controls | – | Other: MRI of the lumbar spine, Other: manual segmental examination of the lumbar facet jointssubjects with less than 30 days of low back pain in the last three months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pain clinic, sports clubs and fitness centers
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- acute radicular low back pain in the last three months
- claustrophobia
- spondylodesis of the lumbar spine
- any metallic implants which are not MRI-compatible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI of the lumbar spinestandard protocol, approximately 30 minutes | Other | controls, current low back pain |
| manual segmental examination of the lumbar facet jointsuse of three different segmental facet joint provocation tests (spinal palpation, segmental rotation and springing-test) from Th12-L1 to L5-S1 | Other | controls, current low back pain |
Primary outcome
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 secondary outcomes
number of painful facet joints per person
Time frame: 2 hours
number of facet joints diagnosed with facet joint effusion and/ or edema per person
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Maier, M.D., PhD study director
Head of the Department of Pain medicine, BG Universitätsklinikum Bergmannsheil GmbH, 44789 Bochum, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Facet Joint Pain, run by Christoph Maier, Prof. Dr. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of facet joints per person which show facet joint pain and FJ effusion and/ or edema (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2012.