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

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ClinicalTrials.gov Identifier: NCT02343484
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Chrysanthi Batistaki, 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Gelified ethanol combined to pulsed radiofrequency Drug: Gelified ethanol Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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 Name: 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:
  • Discogel
  • PRF




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343484


Locations
Greece
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, Greece, 12462
Sponsors and Collaborators
Attikon Hospital

Publications:

Responsible Party: Chrysanthi Batistaki, Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens, Greece, Attikon Hospital
ClinicalTrials.gov Identifier: NCT02343484     History of Changes
Other Study ID Numbers: 2/8-2-13
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

Keywords provided by Chrysanthi Batistaki, Attikon Hospital:
pulsed radiofrequency
gelified ethanol

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs