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

NCT02343484 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-10-03

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

DRUG

Gelified ethanol combined to pulsed radiofrequency

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.

DRUG

Gelified ethanol

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.

Sponsors & Collaborators

  • Attikon Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343484 on ClinicalTrials.gov