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

September 30, 2017 updated by: Chrysanthi Batistaki, Attikon Hospital

Intradiscal Combination of Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for the Treatment of Chronic Discogenic Low Back Pain. A Randomized Controlled Trial.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 12462
        • 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Other Names:
  • Discogel
Active Comparator: 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.
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.
Other Names:
  • PRF
  • Discogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numeric Rating Scale (NRS)
Time Frame: One, three, six and twelve months after the procedure.
Mean pain intensity assessed by VAS 1, 3, 6 and 12 months after the procedure.
One, three, six and twelve months after the procedure.
Change in Rolland Morris questionnaire
Time Frame: 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.
One, three, six and twelve months after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of life (EQ 5D)
Time Frame: 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
One, three, six and twelve months after the procedure.
Change in Satisfaction from therapy ( assessed via NRS 0-10)
Time Frame: 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
One, three, six and twelve months after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

September 30, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/8-2-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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