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. 2015 Oct 23;2015(10):CD008572. doi: 10.1002/14651858.CD008572.pub2

Cohen 2008.

Methods RCT
Participants Johns Hopkins Medical Institutions, Maryland & Walter Reed Army Medical Center, Washington, DC, USA (N = 28)
Inclusion criteria
  • Older than 18 years

  • Axial low back or buttock pain ≥ 6 months

  • Tenderness overlying SI joint(s)

  • Failure to respond to conservative therapy

  • Long‐term (2 months) pain relief with SI joint corticosteroid injections

  • Pain relief ≥ 75% as calculated from a 6‐hour post‐block pain diary after a single diagnostic SI joint injection


Exclusion criteria
  • Focal neurological signs or symptoms

  • Radiological evidence of symptomatic herniated disc

  • Spondyloarthropathy

  • Untreated coagulopathy

  • Unstable medical or psychiatric illness that might preclude an optimal treatment response

Interventions Experiment group
  • Cooled RF denervation group received L4–L5 primary dorsal rami and S1–S3 lateral branch RF denervation (80°C, 90 seconds) using cooling probe technology after local anaesthetic block (N = 14)


Control  group
  • Control group received local anaesthetic block followed by placebo denervation, in which 0.5 mL lidocaine 2% was administered with no current (N = 14)

  • Participants who did not respond to placebo injections crossed over and were treated with RF denervation using conventional technology

Outcomes Significant changes between groups for pain intensity (VAS) 1 and 3 months after treatment, and for function (ODI) 1 month after treatment
  • Pain intensity: change in VAS score at 1 month: ‐3.7 (E), ‐0.2 (C)

  • Pain intensity: change in VAS score at 3 months: ‐3.7 (E), ‐0.5 (C)

  • Function: change in ODI score at 1 month: ‐16.2 (E), ‐4.3 (C)

  • Function: change in ODI score at 3 months: ‐13.1 (E), ‐23.9 (C)

Notes Dropouts: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random assignment in blocks of 4 via pre sealed envelopes
Allocation concealment (selection bias) Low risk Presealed envelopes
Blinding (performance bias and detection bias) 
 All outcomes ‐ patients? High risk Blinding evaluated shortly after conclusion of the procedure, when effects of local anaesthetic were still active
Blinding (performance bias and detection bias) 
 All outcomes ‐ providers? High risk Participants treated with placebo after 1 month
Blinding (performance bias and detection bias) 
 All outcomes ‐ outcome assessors? High risk Participant‐reported outcome measures. Participants who did not show adequate symptomatic improvement were unblinded at follow‐up. For those who reported significant relief 1 month after the procedure, unblinding was done 3 months after treatment
Incomplete outcome data (attrition bias) 
 All outcomes ‐ drop‐outs? Low risk No dropouts; only 3 placebo participants refused to cross over
Incomplete outcome data (attrition bias) 
 All outcomes ‐ ITT analysis? High risk Cross‐over procedure
Selective reporting (reporting bias) Unclear risk No protocol available
Baseline characteristics similar? High risk Meaningful differences in morphine use and function
Co‐interventions avoided or similar? Unclear risk Remained unclear from text
Compliance acceptable? Low risk Irrelevant: single‐session intervention
Timing of outcome assessments similar? Low risk Similar until 3‐month follow‐up