Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire.

NCT04118218 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-10-08

No results posted yet for this study

Summary

Rhizolysis or lumbar thermocoagulation is a therapeutic proposal for certain types of chronic lower back pain that is resistant to medical treatment and outside the field of surgical indications.

A previous study has selected functional and physical signs selected by analysts and a group of experts from the modified "Delphi" prediction method. This study resulted in the creation of a questionnaire (DFL questionnaire) with 16 symptoms: 7 functional and 9 physical.

The aim of this new study is to select the symptoms that have the best positive predictive value among the 16 symptoms, to predict a good result of rhizolysis, on the criterion of their mitigation or disappearance in case of effective rhizolysis.

Conditions

  • Rhizolysis
  • Diagnosis of Facet Joint Origin Lumbago

Interventions

OTHER

Rhizolysis pain analysis

Definition of the subgroup of good clinical outcome after rhizolysis (called "effective" rhizolysis) by lumbar VAS or lower extremity pain VAS or Oswestry index decreased at 6 weeks after rhizolysis. The "efficiency" criterion based on the decrease in the dolorimeter or the Oswestry index corresponds to a decrease of at least 50% \[1, 2, 3, 4\].

Sponsors & Collaborators

  • Dr BARAT

    collaborator UNKNOWN
  • Ramsay Générale de Santé

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118218 on ClinicalTrials.gov