Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain

Study Overview
=================
Brief Summary
-----------------
Prospective study to analyse pain reduction with two types of canulae and two types of placements for lumbar medial branch radiofrequency denervation.

Detailed Description
-----------------
Patients who suffer from lumbar zygapophyseal joint pain often receive radiofrequency medial branch denervation as treatment. Many types if canulae exist, and many types of placing them in relation to the Medial Branch nerves (MB). The EARL study tries to compare the analgesic effect of thin canulae (22 gauge) placed perpendicular to MB to thicker canulae (18 gauge) placed parallel to MB.

Official Title
-----------------
Evaluación de la Analgesia a Corto y Medio Plazo de Las Diferentes Posiciones y Tipos de Las cánulas de Radiofrecuencia, en la denervación Del Ramo Medial Del Nervio Dorsal Lumbar

Conditions
-----------------
Lumbar Facet Joint Pain, Lumbar Medial Branch Neurotomy

Intervention / Treatment
-----------------
* Other: PAIN REDUCTION ON VAS/NRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain of > 3 months 18-80 years VAS or NRS>6 Positive controlled block Exclusion Criteria: Pregnancy Psichiatric disorders Not being able to fulfil questionnaires Body Mass Index>35 Labor Litigation Negative or non conclusive controlled block Failed Back Surgery Syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective comparative study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PARALLEL<br>Thick canulae (18 gauge) placed parallel to Medial Branch under fluoroscopy. | Other: PAIN REDUCTION ON VAS/NRS<br>* Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.<br>|
| Active Comparator: PERPENDICULAR<br>Thin canulae (22 gauge) placed perpendicular to Medial Branch under fluoroscopy. | Other: PAIN REDUCTION ON VAS/NRS<br>* Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAIN REDUCTION ON VAS/NRS | Reduction in pain, at 1,3 and 6 months | 1-3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSWESTRY DISABILITY INDEX | Quantify disability for low back pain. | 1-3-6 months | 
| ROLAND MORRIS | Health status measure for low back pain | 1-3-6 months | 
| MEDICATION REDUCTION | Pain medication reduction | 1-3-6 months | 
| WORKING STATUS | CHANGE IN WORKING STATUS | 1-3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lumbar facet joint pain, Lumbar Medial Branch Neurotomy, Chronic Low Back Pain