Intradiscal Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for Discogenic Low Back Pain
Low Back Pain
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring pulsed radiofrequency, gelified ethanol
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
Sites / Locations
- 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Gelified ethanol
Gelified ethanol combined to pulsed radiofrequency
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.
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.