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Completed

NCT Number: NCT02343484

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Athens, 12462, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gelified ethanol combined to pulsed radiofrequency

Drug

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

Gelified ethanol

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 22, 2015
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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