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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Drug: Gelified ethanol; Drug: Gelified ethanol combined to pulsed radiofrequency

• Registration Number: NCT02343484
• Lead Sponsor: Attikon Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-22
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-30
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gelified ethanol	Gelified ethanol	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.
Gelified ethanol combined to pulsed radiofrequency	Gelified ethanol combined to pulsed radiofrequency	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.; 🇬🇷 Athens, Greece