Selection of Chronic Low Back Pain Patients for Neurotomy Surgery Radiofrequency

NCT05624307 | Unknown

• 1 other identifier: HOP22-RIPH3-02
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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)

Conditions

Pain;Back Low;Chronic

Keywords

Radiofrequency; Facet pain

Outcome Measures

Primary Outcomes (1)

• Brief-Pain Inventory (BPI)

  Patients will be considered responders if the pain score, estimated by the Brief-Pain Inventory (BPI), is reduced by 50% at 1 month compared to the preoperative workup, and non-responders if the pain score did not reduce sufficiently or if the response to block tests was negative. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.

  Pre-operative evaluation, at 1 month

Secondary Outcomes (4)

• The Quebec Back Pain Disability Scale.

  Pre-operative evaluation then at 1, 3 and 6 months post intervention

• Questionnaire Hospital Anxiety and Depression scale (HAD)

  Pre-operative evaluation then at 1, 3 and 6 months post intervention

• EQ-5D-5L Questionnaire

  Pre-operative evaluation then at 1, 3 and 6 months post intervention

• Brief-Pain Inventory (BPI)

  3 and 6 months post intervention

Other Outcomes (1)

• Clinical Global Impression questionnaire (CGI-C)

  Pre-operative evaluation then at 1, 3 and 6 months post intervention

Study Arms (1)

Patient with chronic back pain

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• FondationbHopale: lead

Study Sites (1)

Bruno VEYS

Berck, Hauts-de-France, 62608, France

RECRUITING

Related Links

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Study Officials

• Thomas OLIVIERI

  Hopale Foundation - Calot Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno VEYS

CONTACT

0362882747; Bruno.veys@fondation-hopale.org

Marine DESEUR

CONTACT

0362882780; marine.deseur@fondation-hopale.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: November 21, 2022
• Primary Completion: November 15, 2023
• Study Completion: May 15, 2024
• Last Updated: December 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)