Clinical trial NCT05624307: Selection of Chronic Low Back Pain Patients for Neurotomy Surgery Radiofrequency
Official title: Relevance of the Combined Extension-rotation-lateral Tilt Maneuver in the Selection of Patients With Chronic Low Back Pain for Neurotnomy Intervention Radiofrequency : Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain;Back Low;Chronic
Keywords: Radiofrequency
Facet pain
Lead sponsor: FondationbHopale
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients included in the study were major patients with chronic low back pain.

The patients included in the study will have to respond to 5 questionnaires at 1 month, 3 months and 6 months according to the frequency of post-treatment consultation with RT-NF.

Brief 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 Scale
* Clinical 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 treatment
* Age 18 - 65 years
* Patient did not object to the use of their data
* Patient affiliated to a social security plan

Non inclusion Criteria:

* Patient with a disorder of hemostasis
* Patient with a history of arthrodesis
* Patient with radiologically visible root damage
* Patient with instability of the spine
* Patient with an abnormality on dorso-lumbar MRI: MODIC 1
* Patient under legal protection :

  * Person under guardianship,
  * Person under curatorship,
  * Person under legal protection,
  * Person deprived of liberty,
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Brief-Pain Inventory (BPI)
timeFrame: Pre-operative evaluation, at 1 month
Secondary outcomes:
measure: The Quebec Back Pain Disability Scale.
timeFrame: Pre-operative evaluation then at 1, 3 and 6 months post intervention
measure: Questionnaire Hospital Anxiety and Depression scale (HAD)
timeFrame: Pre-operative evaluation then at 1, 3 and 6 months post intervention
measure: EQ-5D-5L Questionnaire
timeFrame: Pre-operative evaluation then at 1, 3 and 6 months post intervention
measure: Brief-Pain Inventory (BPI)
timeFrame: 3 and 6 months post intervention
Other outcomes:
measure: Clinical Global Impression questionnaire (CGI-C)
timeFrame: Pre-operative evaluation then at 1, 3 and 6 months post intervention
Locations:
city: Berck
country: France
facility: Bruno VEYS
state: Hauts DE France
Study officials:
affiliation: Hopale Foundation - Calot Institute
name: Thomas OLIVIERI
role: PRINCIPAL_INVESTIGATOR
References: