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

R

Ramsay Générale de Santé

Status

Unknown

Conditions

Diagnosis of Facet Joint Origin Lumbago
Rhizolysis

Treatments

Other: Rhizolysis pain analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT04118218
2017-A01283-50

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Jean Francois OUDET; Marie Barba

Data sourced from clinicaltrials.gov

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