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CompletedNCT03308149Updated Oct 12, 2017

Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans

An observational study in Infiltration Facet Joint, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2017-10-12.

Sponsored by University Hospital Tuebingen · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Sex
All
01

Study 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.

02

Conditions studied

  • Infiltration Facet Joint
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who had received inpatient gradual diagnostics in our department

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • ositive history of lumbar surgery or the presence of artificial implants in the area of interest
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • Druginfiltration with triamcinolone and bupivacaine

    facet joint infiltration

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Improvement in pain level within 24 hours

06

Study locations

1 site
  • University Hospital Tuebingen, Department of Orthopaedics
    Tuebingen, 72076, Germany
07

References and documents

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 ↗

Individual participant data

Plan to share: Undecided — General data file from which statistical analyses were performed may be requested from the authors after publication

08

Registry details

Key details

Study ID
NCT03308149
Lead sponsor
University Hospital Tuebingen
Responsible party
Dr. Ulf Krister Hofmann (Principal Investigator, University Hospital Tuebingen) — Principal investigator
First posted
Oct 12, 2017
Start date
Jan 10, 2016
Primary completion
Jan 10, 2017
Completion
Jan 10, 2017
Last update
Oct 12, 2017

Study contacts

Ulf Hofmann, M.D.
principal investigator · Department of Orthpaedic Surgery, University Hospital of Tuebingen

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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