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

NCT02343484 | Completed

• 1 other identifier: 2/8-2-13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

pulsed radiofrequency; gelified ethanol

Outcome Measures

Primary Outcomes (2)

• Change in Numeric Rating Scale (NRS)

  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

  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 Outcomes (2)

• Change in Quality of life (EQ 5D)

  One, three, six and twelve months after the procedure.

• Change in Satisfaction from therapy ( assessed via NRS 0-10)

  One, three, six and twelve months after the procedure.

Study Arms (2)

Gelified ethanol

ACTIVE COMPARATOR

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 combined to pulsed radiofrequency

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Discogel, PRF

Gelified ethanol combined to pulsed radiofrequency

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.

Also known as: Discogel

Gelified ethanol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

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

Athens, 12462, Greece

Location

Related Publications (8)

• Bellini M, Romano DG, Leonini S, Grazzini I, Tabano C, Ferrara M, Piu P, Monti L, Cerase A. Percutaneous injection of radiopaque gelified ethanol for the treatment of lumbar and cervical intervertebral disk herniations: experience and clinical outcome in 80 patients. AJNR Am J Neuroradiol. 2015 Mar;36(3):600-5. doi: 10.3174/ajnr.A4166. Epub 2014 Nov 13.

  PMID: 25395657 BACKGROUND

• 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.

  PMID: 24148546 BACKGROUND

• 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.

  PMID: 17912130 BACKGROUND

• Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Buenaventura RM, Bryce DA, Burks PA, Caraway DL, Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner H, Coubarous S, Datta S, Deer TR, Diwan S, Falco FJ, Fellows B, Geffert S, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm S 2nd, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma ML, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood JR, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49-283.

  PMID: 23615883 BACKGROUND

• 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.

  PMID: 23185729 BACKGROUND

• 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.

  PMID: 22008239 BACKGROUND

• 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.

  PMID: 22476553 BACKGROUND

• 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.

  PMID: 22787545 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens, Greece

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 22, 2015
• Study Start: March 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Locations

GR (1)