Clinical trial NCT02343484: Intradiscal Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for Discogenic Low Back Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: pulsed radiofrequency
gelified ethanol
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Numeric Rating Scale (NRS)
timeFrame: One, three, six and twelve months after the procedure.
measure: Change in Rolland Morris questionnaire
timeFrame: One, three, six and twelve months after the procedure.
Secondary outcomes:
measure: Change in Quality of life (EQ 5D)
timeFrame: One, three, six and twelve months after the procedure.
measure: Change in Satisfaction from therapy ( assessed via NRS 0-10)
timeFrame: One, three, six and twelve months after the procedure.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Study officials:
References:
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citation: Guarnieri G, De Dominicis G, Muto M. Intradiscal and intramuscular injection of discogel((R)) - radiopaque gelified ethanol: pathological evaluation. Neuroradiol J. 2010 Apr;23(2):249-52. doi: 10.1177/197140091002300216. Epub 2010 Apr 20.
citation: Theron J, Guimaraens L, Casasco A, Sola T, Cuellar H, Courtheoux P. Percutaneous treatment of lumbar intervertebral disk hernias with radiopaque gelified ethanol: a preliminary study. J Spinal Disord Tech. 2007 Oct;20(7):526-32. doi: 10.1097/BSD.0b013e318033e860.
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citation: Jung YJ, Lee DG, Cho YW, Ahn SH. Effect of intradiscal monopolar pulsed radiofrequency on chronic discogenic back pain diagnosed by pressure-controlled provocative discography: a one year prospective study. Ann Rehabil Med. 2012 Oct;36(5):648-56. doi: 10.5535/arm.2012.36.5.648. Epub 2012 Oct 31.
citation: Rohof O. Intradiscal pulsed radiofrequency application following provocative discography for the management of degenerative disc disease and concordant pain: a pilot study. Pain Pract. 2012 Jun;12(5):342-9. doi: 10.1111/j.1533-2500.2011.00512.x. Epub 2011 Oct 19.
citation: Fukui S, Rohof O. Results of pulsed radiofrequency technique with two laterally placed electrodes in the annulus in patients with chronic lumbar discogenic pain. J Anesth. 2012 Aug;26(4):606-9. doi: 10.1007/s00540-012-1385-7. Epub 2012 Apr 5.
citation: Fukui S, Nitta K, Iwashita N, Tomie H, Nosaka S, Rohof O. Results of intradiscal pulsed radiofrequency for lumbar discogenic pain: comparison with intradiscal electrothermal therapy. Korean J Pain. 2012 Jul;25(3):155-60. doi: 10.3344/kjp.2012.25.3.155. Epub 2012 Jun 28.