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

Attikon University Hospital

Status: Completed

Conditions: Low Back Pain

Treatments: Drug: Gelified ethanol; Drug: Gelified ethanol combined to pulsed radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT02343484

2/8-2-13

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Gelified ethanol

Active Comparator group

Description:

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.

Treatment:

Drug: Gelified ethanol

Gelified ethanol combined to pulsed radiofrequency

Active Comparator group

Description:

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.

Treatment:

Drug: Gelified ethanol combined to pulsed radiofrequency