Clinical trial NCT04118218: Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire.
Official title: Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire (Diagnosis of Facet Joint Origin Lumbago).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhizolysis
Diagnosis of Facet Joint Origin Lumbago
Keywords: DLF Questionnaire
rhizolysis
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: Dr BARAT
First posted: 2019-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Predictive DFL symptoms
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Clairval Private Hospital
state: Paca
Study officials:
References: