A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy--a 12-month follow-up.
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.
Kvarstein
Gunnvald
G
Department of Anesthesiology and Intensive Care, Section of Pain Management, Oslo University Hospital, Rikshospitalet, Norway Hospital for Rehabilitation, Oslo University Hospital, Rikshospitalet, Norway The Interventional Centre, Oslo University Hospital, Rikshospitalet, Norway Department of Radiology, Oslo University Hospital, Rikshospitalet, Norway Oslo University Hospital, Rikshospitalet and Faculty of Medicine, University of Oslo, Norway.
Måwe
Leif
L
Indahl
Aage
A
Hol
Per Kristian
PK
Tennøe
Bjørn
B
Digernes
Randi
R
Stubhaug
Audun
A
Tønnessen
Tor Inge
TI
Beivik
Harald
H
D000328:Adult; D000704:Analysis of Variance; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D007405:Intervertebral Disc Displacement / Q000150:complications / Q000628:therapy*; D017116:Low Back Pain / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D008159:Lumbar Vertebrae / Q000502:physiology; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D011788:Quality of Life; D020127:Recovery of Function; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome