Selection of Chronic Low Back Pain Patients for Neurotomy Surgery Radiofrequency

Study Results

Results pending

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.

Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-21

Study Completion Date

2024-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Monopolar Dielectric Diathermy by Radiofrequency and Therapeutic Exercise in Patients With Chronic Low Back Pain.

NCT05149690

Chronic Pain

COMPLETED NA

Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain

NCT04803149

Chronic Low-back Pain

UNKNOWN NA

X-ray Guided Facet Block in Chronic Low Back Pain

NCT05676060

Back Pain

UNKNOWN

Radiofrequency Denervation and Brain Imaging

NCT05641948

Low Back Pain, Mechanical

RECRUITING

Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain

NCT05308641

Chronic Low-back Pain (cLBP)

ACTIVE_NOT_RECRUITING NA

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.

Pain;Back Low;Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No