Prospective, non-inferiority, multicenter, randomized, single-blind clinical trial comparing cooled radiofrequency ablation to standard radiofrequency ablation to manage chronic facetogenic lumbar back pain
- terminated early
Authors' conclusion
Despite the smaller than intended sample size, due to early termination by the sponsor, this study demonstrated that with appropriate patient selection and proper procedural technique, both CRFA and SRFA can relieve chronic facetogenic low back pain, improve disability, function, and quality of life for 6-12 months.
Study context
- Population
- Patients with lumbar facetogenic back pain identified by two positive medial branch blocks61 completed 6-month visit
- Participants
- 74 patients
- Comparison
- Cooled RFA vs standard RFA
- Cooled radiofrequency ablation (CRFA)n = 37
- Standard radiofrequency ablation (SRFA)n = 37reference
- Primary endpoint
- Proportion with ≥50% decrease in back pain on NRS (usual, past 7 days)
- Follow-up
- 6 months
Methodological detailsnon-inferiority, multicentre, single-blind, prospective, Enrollment (target 188) ended early after 18 months; only 52% enrolled
- Non-inferiority
- Multicentre
- Single-blind
- Prospective
- Enrollment (target 188) ended early after 18 months; only 52% enrolled
Primary result
As reported in the abstract
≥50% pain relief
P = 0.0069
Secondary outcomes
| Outcome | CRFA | SRFA |
|---|---|---|
| Change in NRS pain score from baseline | −4.3 | −3.4 |
- Change in NRS pain score from baseline — Both groups significant reductions from baseline at every time point
- p≤0.0001
Change in NRS pain score from baseline
- No statistically significant differences in NRS between groups at any time point
NRS, EQ-5D-5L, Oswestry Disability Index (ODI), SF-36 (Physical Functioning (PF)), GPE · 6 and 12 months
- Significant and comparable improvements in both groups
Original publication
Prospective, non-inferiority, multicenter, randomized, single-blind clinical trial comparing cooled radiofrequency ablation to standard radiofrequency ablation to manage chronic facetogenic lumbar back pain. Reg Anesth Pain Med. Published 13 March 2026. doi:10.
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