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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04118218
Acronym
Rhizolyse
Enrollment
100
Registered
2019-10-08
Start date
2017-12-12
Completion date
2020-03-31
Last updated
2019-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis of Facet Joint Origin Lumbago, Rhizolysis

Keywords

DLF Questionnaire, rhizolysis

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.

Interventions

OTHERRhizolysis 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

Dr BARAT
CollaboratorUNKNOWN
Ramsay Générale de Santé
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Predictive DFL symptoms6 weeks• 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

Countries

France

Contacts

Primary ContactJean Francois OUDET
jeanfrancois.oudet@free.fr+33683346567
Backup ContactMarie Barba
mh.barba@ecten.eu+330664888704

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026