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.