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Recruiting
NCT05624307
Selection of Chronic Low Back Pain Patients for Neurotomy Surgery Radiofrequency
Conditions: Pain;Back Low;Chronic
Sex: All
Ages: 18 Years – 65 Years
Enrollment: 160
Sponsor: FondationbHopale
Location: France
Summary
Chronic low back pain is one of the leading causes of disability associated with significant health care costs.
One possible management of chronic low back pain of facet origin is neurotomy-radiofrequency (NT-RF) intervention.
Currently, to determine whether a patient is eligible for NT-RF, two positive block tests are required.Clinical examination with a homolateral extension-rotation-tilt maneuver of the spine (ERI maneuver) would have the potential to identify subjects with pain of facet origin.
It could therefore be a simple and effective diagnostic tool in the evaluation of a patient with low back pain and help in the decision whether or not to perform a test block by local infiltration of the zygapophyseal joint prior to an NT-RF procedure.The purpose of this longitudinal, prospective, observational, single-center study is to evaluate the performance of the combined extension-rotation-lateral tilt maneuver (ERI maneuver) in predicting the response to neurotomy-radiofrequency intervention in patients with chronic low back pain.The included patients will answer 5 questionnaires, in addition to the usual clinical data:Hospital Anxiety and Depression scale (HAD) questionnaire,Quality of life questionnaire EQ-5D-5L,Brief Pain Inventory - French version: Questionnaire Concis de la Douleur (QCD),Functional Impotence Scale for Low Back Pain: The Quebec Back Pain Disability ScaleClinical Global Impression of Change (CGI-C)
Eligibility Criteria
Inclusion Criteria:Patients admitted to the chronic pain service at the Calot Institute with chronic low back pain for at least three months, not responding to well-conducted conservative treatmentAge 18 - 65 yearsPatient did not object to the use of their dataPatient affiliated to a social security planNon inclusion Criteria:Patient with a disorder of hemostasisPatient with a history of arthrodesisPatient with radiologically visible root damagePatient with instability of the spinePatient with an abnormality on dorso-lumbar MRI: MODIC 1Patient under legal protection :Person under guardianship,Person under curatorship,Person under legal protection,Person deprived of liberty,Pregnant or breastfeeding woman
Source: ClinicalTrials.gov (NCT05624307). StuddyBuddy aggregates publicly available trial information.