Selection of Chronic Low Back Pain Patients for Neurotomy Surgery Radiofrequency
NCT ID: NCT05624307
Last Updated: 2022-12-12
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
160 participants
OBSERVATIONAL
2022-11-21
2024-05-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
FondationbHopale
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas OLIVIERI
Role: PRINCIPAL_INVESTIGATOR
Hopale Foundation - Calot Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bruno VEYS
Berck, Hauts-de-France, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Bruno VEYS
Role: primary
Marine DESEUR
Role: backup
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Related Info
Related Info
Related Info
Related Info
Related Info
Related Info
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HOP22-RIPH3-02
Identifier Type: -
Identifier Source: org_study_id