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

Tekin 2007.

Methods RCT
Participants Celal Bayar University, Manisa, Turkey (N = 60)
Inclusion criteria
  • > 17 years of age

  • Continuous low back pain with or without radiating into upper leg, with focal tenderness over facet joints, pain on hyperextension, no finding of obvious neurological defect, no indication for low back surgery, no radicular syndrome, unresponsiveness to traditional conservative treatments; all > 6 months

  • > 50% pain relief on VAS to diagnostic medial branch block


Exclusion criteria
  • Prior RF treatment

  • Coagulation disturbances

  • Allergy to radiopaque contrast media or local anaesthetics

  • Malignancy

  • Mental handicap

  • Psychiatric condition precluding adequate communication

  • Language problems

  • Pregnancy

Interventions Experiment group 1, CRF
  • Continuous radiofrequency lesions to medial branch at 80°C for 90 seconds at level L1 to L3 or L3 to L5  (N = 20)


Experiment group 2, PRF
  • Two Hertz PRF waves were applied for 4 minutes (45V) at 42°C (N = 20)


Control group
  • Electrodes and thermocouple probes were positioned similarly without switching on RF current; only bupivacaine 0.5% 0.3 mL was injected (N = 20)

Outcomes
  • Significant changes in VAS (0 to 10) and ODI scores between PRF and CRF groups compared with control group post procedure and between CRF and control groups after 6 months. At 1 year, VAS scores in CRF groups were lower than those in PRF and control groups. ODI scores were lower for both RF groups at 1 year than for control group

  • Participant satisfaction was lower in the control group than in the other groups, and was highest in the CRF group

    • Pain intensity: change in VAS score post procedure: ‐3.8 (PRF), ‐4.2 (CRF), ‐2.5 (C)

    • Pain intensity: change in VAS score at 6 months: ‐3.7 (PRF), ‐4.2 (CRF), ‐3.7 (C)

    • Pain intensity: change in VAS score at 12 months: ‐3.1 (PRF), ‐4.1 (CRF), ‐2.9 (C)

    • Function: change in ODI score post procedure: ‐15 (PRF), ‐13.6 (CRF), ‐9.6 (C)

    • Function: change in ODI score at 6 months: ‐14.1 (PRF), ‐14.1 (CRF), ‐11.2 (C)

    • Function: ODI score at 12 months: ‐10.9 (PRF), ‐11.2 (CRF), ‐6.5 (C)

Notes Dropouts: unclear
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Subsequent randomisation into 3 groups performed by random number generation, with balance after every 8 participants
Allocation concealment (selection bias) Unclear risk Remained unclear from text
Blinding (performance bias and detection bias) 
 All outcomes ‐ patients? Low risk Participants not able to state which treatment they were receiving
Blinding (performance bias and detection bias) 
 All outcomes ‐ providers? High risk Providers not blinded
Blinding (performance bias and detection bias) 
 All outcomes ‐ outcome assessors? Low risk Participant reported outcomes measured and the latest outcome data evaluated by an independent observer
Incomplete outcome data (attrition bias) 
 All outcomes ‐ drop‐outs? Unclear risk It is expected to be unlikely that all participants completed follow‐up
Incomplete outcome data (attrition bias) 
 All outcomes ‐ ITT analysis? Low risk Participants analysed by group; no dropouts
Selective reporting (reporting bias) Unclear risk No protocol available
Baseline characteristics similar? Low risk No meaningful differences at baseline
Co‐interventions avoided or similar? High risk Number of participants using analgesics higher in control group than in PRF group
Compliance acceptable? Low risk Irrelevant: single‐session intervention
Timing of outcome assessments similar? Low risk Follow‐up immediately after procedure, at 6 months and at 1 year