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

Attikon Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Low Back Pain

Interventions

Gelified ethanol combined to pulsed radiofrequencyDRUG

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.

Gelified ethanolDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Athens, Greece

Outcomes

Primary Outcomes

Change in Numeric Rating Scale (NRS)

Mean pain intensity assessed by VAS 1, 3, 6 and 12 months after the procedure.

Time frame: 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.

Time frame: One, three, six and twelve months after the procedure.

Secondary Outcomes

Change in Quality of life (EQ 5D)

Quality of life assessed via EQ 5D questionnaire 1, 3, 6 and 12 months after the procedure

Time frame: 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

Time frame: One, three, six and twelve months after the procedure.

Data from ClinicalTrials.gov

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