A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy – A 12-month follow-up

Abstract

The discTRODE probe applies radiofrequency (RF) current, heating the annulus to treat chronic discogenic low back pain. Randomized controlled studies have not been published. We assessed the long-term effect and safety aspects of percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) with the discTRODE probe in a prospective parallel, randomized and gender stratified, double-blind placebo-controlled study. Twenty selected patients with chronic low back pain and a positive one-level pressure-controlled provocation discography were randomized to either intra-annular PIRFT or intra-annular sham treatment. A blinded interim analysis was performed when 20 patients had been followed for six months. The 6-month analysis did not reveal any trend towards overall effect or difference between active and sham treatment for the primary endpoint: change in pain intensity (0-10). The inclusion of patients was therefore discontinued. After 12 months the overall reduction from baseline pain had reached statistical significance, but there was no significant difference between the groups. The functional outcome measures (Oswestry Disability Index, and SF 36 subscales and the relative change in pain) appeared more promising, but did not reach statistical significance when compared with sham treatment. Two actively treated and two sham-treated patients reported increased pain levels, and in both groups a higher number was unemployed after 12 months. The study did not find evidence for a benefit of PIRFT, although it cannot rule out a moderate effect. Considering the high number, reporting increased pain in our study, we would not recommend intra-annular thermal therapy with the discTRODE probe.

Nonoperative Management of Discogenic Back Pain

“…Furthermore, there were no significant differences in ODI and SF-36 scores or patients’ categorical impression of pain at 6 or 12 months between the two groups. 46 A similar study by Barendse et al 47 also investigated PIRFT using a different protocol (90 seconds, 70 C lesion) also found no significant differences between sham and active group for any of the outcome scores at 8 weeks. 47 (Table 5)…”

“…Recruitment for a PIRFT study by Kvarstein et al 46 was prematurely halted 6 months into the study due to lack of trend toward improvement for the PIRFT group thereby limiting the study to 20 subjects. There were no significant differences in any NRS (Numeric Rating Scale) scores or changes in these scores from baseline between the two groups at 6 or 12 months.…”

“…Kvarstein et al 46 had a total of 20 subjects (10 patients in treatment and sham groups) and prematurely halted the study due to lack of trends towards significance. However, while the differences between treatment and sham groups were statistically non-significant, the results were still positive for the PIRFT group and therefore a larger study population could potentially lead to significant differences favoring the treatment group.…”

Application of Radiofrequency in Low Back Pain Treatment

“…RF applying to the disc itself included transdiscal biacuplasty (Baylis Medical Inc., Montreal, Canada), intradiscal electrothermal therapy (IDET) with spinecath (OratecInterventions, Inc., Menlo Park, CA) and disctrode (Radionics RFG-3C,Valleylab, Tyco Healthcare Group LP 5920 Longbow Drive, Boulder, Colorado 80301-3299 USA) (Karasek & Bogduk 2000;Saal JA & Saal JS, 2000Davis et al, 2004;Kapural & Mekhail 2006;Andersson et al, 2006;Kvarstein et al, 2009;. The spinecath and disctrode are flexible catheters with a distal thermocoil.…”

Interventionen an der Bandscheibe

“…c systematisches Review und Metaanalyse. d Fallserie.SF-36 und Oswestry-Index, während Freeman et al[42] keinen signifikanten Vorteil von IDET gegenüber einer Scheinbehandlung feststellen konnten.Weitere thermale Prozeduren am Anulus mittels RF-Technologie stellen die intradiskale Biakuplastie (IDB[44]) und discTRODE[45] dar.Insgesamt weisen die hier beschriebenen perkutanen Verfahren basierend auf den USPSTF-Kriterien (US American Preventive Service Task Force; gute, mittlere, geringe und schlechte Evidenz) nur limitierte Evidenzen auf[46]. Die Metaanalyse von Manchikanti et al[33] beschreibt eine geringe bis mittlere Evidenz für Nukleoplastie, PLDD, IDET und Biakuplastie und geringe Evidenz für APLD, Dekompressor und discTrode.…”