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

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ClinicalTrials.gov Identifier: NCT03308149
Recruitment Status : Completed
First Posted : October 12, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Ulf Krister Hofmann, University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment
Infiltration Facet Joint Drug: infiltration with triamcinolone and bupivacaine

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans
Actual Study Start Date : January 10, 2016
Actual Primary Completion Date : January 10, 2017
Actual Study Completion Date : January 10, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: infiltration with triamcinolone and bupivacaine
    facet joint infiltration


Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who had received inpatient gradual diagnostics in our department
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308149


Locations
Germany
University Hospital Tuebingen, Department of Orthopaedics
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Ulf Hofmann, M.D. Department of Orthpaedic Surgery, University Hospital of Tuebingen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ulf Krister Hofmann, Principal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03308149     History of Changes
Other Study ID Numbers: 503/2016BO2
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: General data file from which statistical analyses were performed may be requested from the authors after publication

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bupivacaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action