Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire. (Rhizolyse)
Primary Purpose
Rhizolysis, Diagnosis of Facet Joint Origin Lumbago
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rhizolysis pain analysis
Sponsored by
About this trial
This is an interventional other trial for Rhizolysis focused on measuring DLF Questionnaire, rhizolysis
Eligibility Criteria
Inclusion Criteria:
- Patient suffering from chronic lower back pain developing for more than 6 months and resistant to the medical treatments.
- Patients with an indication of lumbar rhizolysis for their chronic lower back pain with a facet component, the starting point of which corresponds to the L4L5 and/or L5S1 stages.
- Patient not objecting to their participation in the study.
- Subject registered with a social security scheme
Exclusion Criteria:
- Adults under judicial protection
- Adult under guardianship or trusteeship
- Pregnant women
- Minors
Sites / Locations
- Clairval Private HospitalRecruiting
Outcomes
Primary Outcome Measures
Predictive DFL symptoms
• Comparison of the "effective rhizolysis" and "non-effective rhizolysis" subgroups at 6 weeks postoperatively to select the symptoms with the highest positive predictive value among the 16 symptoms of the DFL questionnaire based on the criterion of effectiveness of a decrease of 50% of VAS or Oswestry
Secondary Outcome Measures
Full Information
NCT ID
NCT04118218
First Posted
October 4, 2019
Last Updated
October 4, 2019
Sponsor
Ramsay Générale de Santé
Collaborators
Dr BARAT
1. Study Identification
Unique Protocol Identification Number
NCT04118218
Brief Title
Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire.
Acronym
Rhizolyse
Official Title
Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire (Diagnosis of Facet Joint Origin Lumbago).
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
Dr BARAT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
The frequency of chronic lower back pain is a major economic and social problem. Indeed, there are numerous solutions that can be offered to patients, but sometimes they are unsatisfactory as medical treatments are often insufficiently effective, surgical techniques are often invasive and indications can be limited.
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. This technique, which is minimally invasive, is low-risk for patients and is widely used. However, few studies have shown its effectiveness, so the level of evidence is not enough to make this technique accepted as a standard.
A previous study has selected functional and physical signs for joint involvement in lower back pain. This selection was made 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhizolysis, Diagnosis of Facet Joint Origin Lumbago
Keywords
DLF Questionnaire, rhizolysis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Rhizolysis pain analysis
Intervention Description
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].
Primary Outcome Measure Information:
Title
Predictive DFL symptoms
Description
• Comparison of the "effective rhizolysis" and "non-effective rhizolysis" subgroups at 6 weeks postoperatively to select the symptoms with the highest positive predictive value among the 16 symptoms of the DFL questionnaire based on the criterion of effectiveness of a decrease of 50% of VAS or Oswestry
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient suffering from chronic lower back pain developing for more than 6 months and resistant to the medical treatments.
Patients with an indication of lumbar rhizolysis for their chronic lower back pain with a facet component, the starting point of which corresponds to the L4L5 and/or L5S1 stages.
Patient not objecting to their participation in the study.
Subject registered with a social security scheme
Exclusion Criteria:
Adults under judicial protection
Adult under guardianship or trusteeship
Pregnant women
Minors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Francois OUDET
Phone
+33683346567
Email
jeanfrancois.oudet@free.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Barba
Phone
+330664888704
Ext
+330664888704
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Clairval Private Hospital
City
Marseille
State/Province
Paca
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Francois OUDET
Phone
+33683346567
Ext
+33683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name & Degree
Marie Barba
Phone
+330664888704
Ext
+330664888704
Email
mh.barba@ecten.eu
12. IPD Sharing Statement
Learn more about this trial
Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire.
We'll reach out to this number within 24 hrs