drugset / Trial / NCT02343484
Intradiscal Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for Discogenic Low Back Pain
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2013-03
- Primary completion
- 2017-09
- Completion
- 2017-09
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gelified ethanol | Unknown | — | Other |
Indications
No indication recorded.