Randomised sham-controlled double-blind multicentre clinical trial to ascertain the effect of percutaneous radiofrequency treatment for lumbar facet joint pain.
OBJECTIVE
The aim of this study was to compare the effect of a percutaneous radiofrequency heat lesion at the medial branch of the primary dorsal ramus with a sham procedure, for the treatment of lumbar facet joint pain.


METHODS
A randomised sham-controlled double blind multicentre trial was carried out at the multidisciplinary pain centres of two hospitals. A total of 60 patients aged > 18 years with a history and physical examination suggestive of facet joint pain and a decrease of ≥ 2 on a numerical rating scale (NRS 0 to 10) after a diagnostic facet joint test block were included. In the treatment group, a percutaneous radiofrequency heat lesion (80oC during 60 seconds per level) was applied to the medial branch of the primary dorsal ramus. In the sham group, the same procedure was undertaken without for the radiofrequency lesion. Both groups also received a graded activity physiotherapy programme. The primary outcome measure was decrease in pain. A secondary outcome measure was the Global Perceived Effect scale (GPE).


RESULTS
There was a statistically significant effect on the level of pain in the factor Period (T0-T1). However, there was no statistically significant difference with the passage of time between the groups (Group × Period) or in the factor Group. In the crossover group, 11 of 19 patients had a decrease in NRS of ≥ 2 at one month crossover (p = 0.65). There was no statistically significant difference in satisfaction with the passage of time between the groups (Group × Period). The independent factors Group and Period also showed no statistically significant difference. There was no statistically significant Group × Period effect for recovery, neither an effect of Group or of Period.


CONCLUSIONS
The null hypothesis of no difference in the decrease in pain and in GPE between the treatment and sham groups cannot be rejected. Post hoc analysis revealed that the age of the patients and the severity of the initial pain significantly predicted a positive outcome. Cite this article: Bone Joint J 2016;98-B:1526-33.
Bravis Hospital, Boerhaaveplein 1, 4624 VT Bergen op Zoom, The Netherlands.
C W J
CW
van Tilburg
Erasmus MC University Medical Center, 's-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.
D L
DL
Stronks
Erasmus MC University Medical Center, 's-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.
J G
JG
Groeneweg
Erasmus MC University Medical Center, 's-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.
F J P M
FJ
Huygen
D000328:Adult; D000367:Age Factors; D000368:Aged; D017115:Catheter Ablation / Q000379:methods*; D003714:Denervation / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000601:surgery*; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D009407:Nerve Block / Q000379:methods; D010147:Pain Measurement / Q000379:methods; D016896:Treatment Outcome
Facet joint; Low back pain; Mechanical low back pain; Radiofrequency; Spine