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

October 6, 2017 updated by: Dr. Ulf Krister Hofmann, University Hospital Tuebingen
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • University Hospital Tuebingen, Department of Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who had received inpatient gradual diagnostics in our department

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Improvement in pain level within 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Ulf Hofmann, M.D., Department of Orthpaedic Surgery, University Hospital of Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2016

Primary Completion (Actual)

January 10, 2017

Study Completion (Actual)

January 10, 2017

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (Actual)

October 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 6, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 503/2016BO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

General data file from which statistical analyses were performed may be requested from the authors after publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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