Fibromyalgia & musculoskeletal pain
Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial
Authors' conclusion
Denervation of the medial branch nerve by either cryoneurolysis or RF compared with placebo did not demonstrate significant improvement in PGIC, pain intensity, function and quality of life in patients with facetogenic chronic LBP at short-term or long-term follow-up.
Study context
- Population
- Adults >18 years with facetogenic chronic low back pain (LBP) >3 months, average NRS LBP≥4 over last 14 days and positive diagnostic medial branch block (>50% pain reduction after 60 min); inclusion March 2020 to September 2022
- Participants
- 120 adults
- Comparison
- Cryoneurolysis or radio frequency (RF) of the medial branch nerves vs placebo
- Primary endpoint
- PGIC
- Follow-up
- 4 weeks after the intervention
Methodological detailssingle-centre, single-blinded, placebo-controlled, block randomised 1:1:1
- Single-centre
- Single-blinded
- Placebo-controlled
- Block randomised 1:1:1
Primary result
As reported in the abstract
4 weeks
Each group vs placeboRelative risk (95% CI)P value
Cryoneurolysis
2(0.75–5.33)
P = 0.17RF
1.6(0.57–4.49)
P = 0.37Secondary outcomes
| Outcome | RR (95% CI) | P value | |
|---|---|---|---|
| PGIC at 6-month follow-up · 6 monthsCryoneurolysisvs Placebo | 5.1 (1.20–22.03) | P = 0.03 | |
| 0.050.21520Relative risk (log scale) |
Secondary outcomes (NRS pain, SF-36, EQ-5D-5L, Oswestry Disability Index, depression, catastrophising) · 4 weeks, 3, 6 and 12 months
- No statistically significant differences in secondary follow-up endpoints
Original publication
Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial. RMD Open. Published 9 May 2024. doi:10. 1136/ rmdopen-2024-004196
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