Infiltration Facet JointNCT03308149
Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans
An observational study of Infiltration Facet Joint, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Fifty MRI scans of patients with chronic lumbar back pain were graded radiologically using a wide range of classification and measurement systems. The reported effect of facet joint injections at the site was recorded and a comparative analysis performed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infiltration Facet Joint
- What is being tested?
- infiltration with triamcinolone and bupivacaine
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jan 2016to 10 Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who had received inpatient gradual diagnostics in our department
Who may be able to join
- patients who had received inpatient gradual diagnostics for chronic lumbar back pain
- monosegmental facet joint infiltration on the first day of inpatient gradual diagnostics
- clearly stated pain relief in percentage (%) for that specific infiltration in the medical documentation
- pain level prior to infiltration needed to be clearly documented
- a high-quality MRI available before infiltration.
Who cannot join
- ositive history of lumbar surgery or the presence of artificial implants in the area of interest
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen, Department of Orthopaedics
Tübingen, 72076
About this study
Fifty MRI scans of patients with chronic lumbar back pain were graded radiologically using a wide range of classification and measurement systems. The reported effect of facet joint injections at the site was recorded and a comparative analysis performed.
- Conditions
- Infiltration Facet Joint
- Being tested
- infiltration with triamcinolone and bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infiltration with triamcinolone and bupivacaineDrug
facet joint infiltration
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of radiologic findings and reported pain relief
Pain relief is assessed as an improvement in % on the NRS. Radiologic findings consist of numerous classification systems and measurement techniques to evaluate and classify spinals and neural foramen stenosis, like for example as suggested by Schizas, or the sagittal diameter of the spinal canal
Measured: Improvement in pain level within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start10 Jan 2016
- Primary completion10 Jan 2017
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infiltration Facet JointStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ulf Krister Hofmann, University Hospital Tuebingen
- Investigators
- Ulf Hofmann, M.D., Principal investigator, Department of Orthpaedic Surgery, University Hospital of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308149
- Sponsor's protocol ID
- 503/2016BO2
- Status last verified
- Oct 2017
- First submitted
- 28 Sep 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: General data file from which statistical analyses were performed may be requested from the authors after publication
Publications
Hofmann UK, Keller RL, Walter C, Mittag F. Predictability of the effects of facet joint infiltration in the degenerate lumbar spine when assessing MRI scans. J Orthop Surg Res. 2017 Nov 21;12(1):180. doi: 10.1186/s13018-017-0685-x.
PubMed 29162138
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans
- ClinicalTrials.gov ID
- NCT03308149
- Acronym / sponsor ID
- 503/2016BO2
- Conditions
- Infiltration Facet Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 12 Oct 2017 (actual)
- 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.
Fifty MRI scans of patients with chronic lumbar back pain were graded radiologically using a wide range of classification and measurement systems. The reported effect of facet joint injections at the site was recorded and a comparative analysis performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who had received inpatient gradual diagnostics in our department
Key inclusion criteria (5 listed)
- patients who had received inpatient gradual diagnostics for chronic lumbar back pain
- monosegmental facet joint infiltration on the first day of inpatient gradual diagnostics
- clearly stated pain relief in percentage (%) for that specific infiltration in the medical documentation
- pain level prior to infiltration needed to be clearly documented
- a high-quality MRI available before infiltration.
Key exclusion criteria (1 listed)
- ositive history of lumbar surgery or the presence of artificial implants in the area of interest
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 |
|---|---|---|
| infiltration with triamcinolone and bupivacainefacet joint infiltration | Drug | – |
Primary outcome
Correlation of radiologic findings and reported pain relief
Time frame: Improvement in pain level within 24 hours
Pain relief is assessed as an improvement in % on the NRS. Radiologic findings consist of numerous classification systems and measurement techniques to evaluate and classify spinals and neural foramen stenosis, like for example as suggested by Schizas, or the sagittal diameter of the spinal canal
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 12 Oct 2017.
- Derived from this study: PubMed 29162138Hofmann UK, Keller RL, Walter C, Mittag F. Predictability of the effects of facet joint infiltration in the degenerate lumbar spine when assessing MRI scans. J Orthop Surg Res. 2017 Nov 21;12(1):180. doi: 10.1186/s13018-017-0685-x.
- Individual participant dataSharing planned: Undecided. General data file from which statistical analyses were performed may be requested from the authors after publication
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Chronic Low-back Pain
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.
Ulf Hofmann, M.D. principal investigator
Department of Orthpaedic Surgery, University Hospital of Tuebingen
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 Infiltration Facet Joint, run by University Hospital Tuebingen 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 1 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 12 Oct 2017. 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?
Correlation of radiologic findings and reported pain relief (time frame: Improvement in pain level within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308149, which also lists 1 linked publication.
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 12 Oct 2017.