Intradiscal Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for Discogenic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Many different minimally invasive techniques have been used for the treatment of chronic discogenic low back pain refractory to conservative treatments, with various results. The aim of this study is to assess the efficacy of the combination of intradiscal pulsed radiofrequency and gelified ethanol versus gelified ethanol alone, on pain and quality of life of patients sufferring from chronic discogenic low back pain.

Official Title
-----------------
Intradiscal Combination of Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for the Treatment of Chronic Discogenic Low Back Pain. A Randomized Controlled Trial.

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: Gelified ethanol combined to pulsed radiofrequency
* Drug: Gelified ethanol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Discogenic low back pain > 6 months, pain refractory to conservative treatment, no other aetiology for pain, pain reported during provocative discography according to standard criteria, MRI imaging indicating disk degenarative disease Exclusion Criteria: Red flags for low back pain, lumbosacral radiculopathy, extruded or sequestered lumbar disc, severe spinal stenosis, facet joint syndrome, sacroiliac joint pain, neurological disorders, psychiatric disorders, rheumatoid arhtritis, ancylosing spondylitis, other autoimmune arthritis, coagulation disorders, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gelified ethanol<br>Gelified ethanol (Discogel) is a sterile, implantable medical solution containing ethyl alcohol, cellulose derivative product and an opaque agent (tungsten). The implant is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally. The implant causes migration of fluid (by hydrophilic and osmotic phenomena) from the periphery towards the center, causing disk reinforcement. Filling of the annulus fibrosus tears interrupts the outflow of inflammatory factors towards dorsal root ganglions, dura and posterior longitudinal ligament. | Drug: Gelified ethanol<br>* Gelified ethanol is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally.<br>* Other names: Discogel;|
| Active Comparator: Gelified ethanol combined to pulsed radiofrequency<br>Pulsed radiofrequency treatment is performed intradiscally for the management of chronic discogenic low back pain.Intradiscal pulsed radiofrequency is first applied and then combined to gelified ethanol injection via the same radiofrequency needle. | Drug: Gelified ethanol combined to pulsed radiofrequency<br>* Gelified ethanol (Discogel) is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally. Pulsed radiofrequency treatment is performed intradiscally for the management of chronic discogenic low back pain. The intradiscal pulsed radiofrequency is first applied and then combined to gelified ethanol injection via the same radiofrequency needle.<br>* Other names: PRF;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numeric Rating Scale (NRS) | Mean pain intensity assessed by VAS 1, 3, 6 and 12 months after the procedure. | One, three, six and twelve months after the procedure. | 
| Change in Rolland Morris questionnaire | Functional status of patient assessed by Rolland Morris questionnaire 1, 3, 6 and 12 months after the procedure. | One, three, six and twelve months after the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life (EQ 5D) | Quality of life assessed via EQ 5D questionnaire 1, 3, 6 and 12 months after the procedure | One, three, six and twelve months after the procedure. | 
| Change in Satisfaction from therapy ( assessed via NRS 0-10) | Satisfaction from therapy assessed via NRS 0-10 1, 3, 6 and 12 months after the procedure | One, three, six and twelve months after the procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulsed radiofrequency, gelified ethanol