title: Randomized Sham-controlled Double-Blind Multicenter Clinical Trial to Ascertain the Effect of Percutaneous Radiofrequency Treatment for Sacroiliac Joint Pain: Three-month Results.
abstract: To investigate the effect of a percutaneous radiofrequency (RF) heat lesion compared with a sham procedure, applied to the lateral branches of L5, S1, S2, S3, and S4 nerve roots.
  
  
  
  Sixty patients aged 18 years and above with a medical history and physical examination suggestive for sacroiliac joint pain and a reduction of 2 or more on a numerical rating scale (NRS, 0 to 10) after a sacroiliac joint test block were included in this study. Treatment group: percutaneous RF heat lesion at the lateral branches of S1, S2, S3, and S4 nerve roots and the posterior ramus dorsalis of L5; sham group: same procedure as the treatment group except for the RF heat lesion.
  
  
  
  pain reduction (NRS). Secondary outcome measure: Global Perceived Effect.
  
  
  
  No statistically significant differences in pain level over time between the groups (Group×Period) (F1,58=0.353; P=0.56) nor within the treatment Group (F1,58=0.212; P=0.65) were found. The Period factor, however, yielded a significant difference (F1,58=61.67; P<0.001), that is, when pooled together the mean pain level of the patients was significantly reduced at T1 compared with T0. In the crossover group, 42.1% experienced a reduction in NRS of 2 or more at 1 month (P=0.65). No statistically significant difference in satisfaction over time between the groups was found (F1,50=2.1; P=0.15). The independent factors Group (F1,50=2.02; P=0.16) and Period (F1,50=0.95; P=0.33) also showed no statistically significant difference. The same applies to recovery: no statistically significant Group×Period effect (F1,51=0.09; P=0.77) was found, neither an effect of Group (F1,51=0.004; P=0.95) nor of Period (F1,51=0.27; P=0.60).
  
  
  
  The hypothesis of no difference in pain reduction or in Global Perceived Effect between the treatment and sham group cannot be rejected.
  
  
  
  Level 1A.
authors.affiliation: *Department of Anesthesiology, Multidisciplinary Pain Center, Bravis Hospital, Boerhaaveplein, Bergen op Zoom †Center for Pain Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands.
authors.forename: Cornelis W J
authors.initials: CW
authors.lastname: van Tilburg
authors.forename: Fleur A
authors.initials: FA
authors.lastname: Schuurmans
authors.forename: Dirk L
authors.initials: DL
authors.lastname: Stronks
authors.forename: Johannes G
authors.initials: JG
authors.lastname: Groeneweg
authors.forename: Frank J P M
authors.initials: FJ
authors.lastname: Huygen
mesh_terms: D018771:Arthralgia / Q000628:therapy*; D059350:Chronic Pain / Q000628:therapy; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017116:Low Back Pain / Q000628:therapy; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D000078702:Radiofrequency Therapy; D012446:Sacroiliac Joint; D017211:Treatment Failure