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

Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343484
• Other study ID #: 2/8-2-13
• Status: Completed
• Phase: N/A
• First received: January 13, 2015
• Last updated: September 30, 2017
• Start date: March 2013
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

References & 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. — View 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. — View 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. — View Citation

Guarnieri G, De Dominicis G, Muto M. Intradiscal and intramuscular injection of discogel(®) - radiopaque gelified ethanol: pathological evaluation. Neuroradiol J. 2010 Apr;23(2):249-52. Epub 2010 Apr 20. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change in Quality of life (EQ 5D)	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.
Secondary	Change in Satisfaction from therapy ( assessed via NRS 0-10)	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.