Randomized prospective trial of cooled versus traditional radiofrequency ablation of the medial branch nerves for the treatment of lumbar facet joint pain

Reg Anesth Pain Med. 2019 Mar;44(3):389-397. doi: 10.1136/rapm-2018-000035.

Abstract

Background and objectives: No previous study has assessed the outcomes of cooled radiofrequency ablation (C-RFA) of the medial branch nerves (MBN) for the treatment of lumbar facet joint pain nor compared its effectiveness with traditional RFA (T-RFA). This study evaluated 6-month outcomes for pain, function, psychometrics, and medication usage in patients who underwent MBN C-RFA versus T-RFA for lumbar Z-joint pain.

Methods: In this blinded, prospective trial, patients with positive diagnostic MBN blocks (>75% relief) were randomized to MBN C-RFA or T-RFA. The primary outcome was the proportion of 'responders' (≥50% Numeric Rating Scale (NRS) reduction) at 6 months. Secondary outcomes included NRS, Oswestry Disability Index (ODI), and Patient Global Impression of Change.

Results: Forty-three participants were randomized to MBN C-RFA (n=21) or T-RFA (n=22). There were no significant differences in demographic variables (p>0.05). A ≥50% NRS reduction was observed in 52% (95% CI 31% to 74%) and 44% (95% CI 22% to 69%) of participants in the C-RFA and T-RFA groups, respectively (p=0.75). A ≥15-point or ≥30% reduction in ODI score was observed in 62% (95% CI 38% to 82%) and 44% (95% CI 22% to 69%) of participants in the C-RFA and T-RFA groups, respectively (p=0.21).

Conclusions: When using a single diagnostic block paradigm with a threshold of >75% pain reduction, both treatment with both C-RFA and T-RFA resulted in a success rate of approximately 50% when defined by both improvement in pain and physical function at 6-month follow-up. While the success rate was higher in the C-RFA group, this difference was not statistically significant.

Trial registration number: NCT02478437.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Arthralgia / diagnostic imaging
  • Arthralgia / therapy*
  • Catheter Ablation / methods*
  • Catheter Ablation / trends
  • Cryotherapy / methods*
  • Cryotherapy / trends
  • Female
  • Follow-Up Studies
  • Humans
  • Lumbar Vertebrae* / diagnostic imaging
  • Male
  • Middle Aged
  • Prospective Studies
  • Single-Blind Method
  • Treatment Outcome
  • Zygapophyseal Joint* / diagnostic imaging

Associated data

  • ClinicalTrials.gov/NCT02478437