Selection of Chronic Low Back Pain Patients for Neurotomy Surgery Radiofrequency
- Conditions
- Pain;Back Low;Chronic
- Registration Number
- NCT05624307
- Lead Sponsor
- FondationbHopale
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brief-Pain Inventory (BPI) Pre-operative evaluation, at 1 month 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.
- Secondary Outcome Measures
Name Time Method EQ-5D-5L Questionnaire Pre-operative evaluation then at 1, 3 and 6 months post intervention The EQ-5D-5L consists essentially of 2 pages: the EQ-5D descriptive system and the EQ Visual Analog Scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' scored 100 and 'The worst health you can imagine' scored 0. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.Questionnaire Hospital Anxiety and Depression scale (HAD) Pre-operative evaluation then at 1, 3 and 6 months post intervention The Hospital Anxiety and Depression scale (HAD) questionnaire is used to screen for anxiety and depressive disorders. It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score: 21). A score close to 0 means no anxiety symptoms a score close to 11 and above indicates anxiety symptoms. This scale is validated in French.
The Quebec Back Pain Disability Scale. Pre-operative evaluation then at 1, 3 and 6 months post intervention It is a self-assessment scale of disability, which deals with the impact on daily life and low back pain. It has 20 items, scored from 0 to 5, giving an overall score. The higher the score, the greater the functional impact of low back pain. This scale is validated in French.
Brief-Pain Inventory (BPI) 3 and 6 months post intervention Patients will be considered responders if the pain score, estimated by the Brief-Pain Inventory (BPI). 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.
Evolution of BPI scores at 3 and 6 months in patients who responded to treatment at 1 month
Trial Locations
- Locations (1)
Bruno VEYS
🇫🇷Berck, Hauts DE France, France