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Cooled radiofrequency ablation provides extended clinical utility in the management of chronic sacroiliac joint pain: 12-month follow-up results from the observational phase of a randomized, multicenter, comparative-effectiveness crossover study.

Regional anesthesia and pain medicine2025-03-16PubMed
Total: 74.0Innovation: 7Impact: 7Rigor: 8Citation: 7

Summary

In patients with injection-confirmed sacroiliac joint pain, cooled radiofrequency ablation produced sustained 12-month pain reduction (mean NRS 6.4 to 3.5; ~57% responders) and improvements in quality of life and disability, with similar benefits in crossover patients. No serious CRFA-related adverse events were reported.

Key Findings

  • Mean pain NRS decreased from 6.4±1.4 to 3.5±2.6 at 12 months in the randomized CRFA cohort; 57.4% met responder criteria.
  • Crossover patients achieved similar 12-month improvements (mean NRS 6.1±1.5 to 3.4±2.5; ~55.6% responders).
  • Clinically meaningful gains in EQ-5D-5L (+0.22±0.27 CRFA; +0.21±0.33 XO) and ODI (−12.4%±14.7 CRFA; −13.7%±17.1 XO); no serious CRFA-related adverse events.

Clinical Implications

For injection-confirmed SIJ pain, CRFA can be considered earlier in the pathway for patients responding to prognostic blocks, with expectations of 12-month benefit and low serious adverse event risk.

Why It Matters

Provides multicenter, randomized comparative-effectiveness evidence with 12-month durability supporting CRFA as a disease-modifying option for SIJ pain. This can influence payer coverage, clinical pathways, and guideline recommendations.

Limitations

  • Observational 12-month extension with crossover complicates strict between-group comparisons and may introduce selection bias.
  • Lack of sham control limits inference about placebo effects.

Future Directions

Head-to-head trials versus alternative interventional options, cost-effectiveness analyses, and subgroup analyses to identify predictors of sustained response.

Study Information

Study Type
RCT
Research Domain
Treatment
Evidence Level
II - Randomized comparative-effectiveness trial with observational 12-month follow-up and crossover
Study Design
OTHER