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

Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire (Diagnosis of Facet Joint Origin Lumbago).

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.

Study Overview

• Status: Unknown
• Conditions: Rhizolysis; Diagnosis of Facet Joint Origin Lumbago
• Intervention / Treatment: Other: Rhizolysis pain analysis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13009
      • Recruiting
      • Clairval Private Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: Dr BARAT

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: DLF Questionnaire; rhizolysis
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Disease
• Other Study ID Numbers: 2017-A01283-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No