Fibromyalgia & musculoskeletal pain

Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial

RMD OpenPublished 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 = 0.17
RF
1.6(0.57–4.49)
P = 0.37

Secondary outcomes

OutcomeRR (95% CI)P value
PGIC at 6-month follow-up · 6 monthsCryoneurolysisvs Placebo5.1 (1.20–22.03)P = 0.03

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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