Selection of Chronic Low Back Pain Patients for Neurotomy Surgery Radiofrequency (RaFr)

FondationbHopale

Status: Enrolling

Conditions: Pain;Back Low;Chronic

Study type: Observational

Funder types: Other

Identifiers

NCT05624307

HOP22-RIPH3-02

Details and patient eligibility

About

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)

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

160 participants in 1 patient group

Patient with chronic back pain

Description:

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