Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire.
NCT ID: NCT04118218
Last Updated: 2019-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-12-12
2020-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Interventions
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Rhizolysis 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% \[1, 2, 3, 4\].
Eligibility Criteria
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Inclusion Criteria
* 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
* Adult under guardianship or trusteeship
* Pregnant women
* Minors
18 Years
ALL
No
Sponsors
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Dr BARAT
UNKNOWN
Ramsay Générale de Santé
OTHER
Responsible Party
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Locations
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Clairval Private Hospital
Marseille, PACA, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-A01283-50
Identifier Type: -
Identifier Source: org_study_id
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