RMD Open (May 2024)

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

  • Maurits van Tulder,
  • Lone Nikolajsen,
  • Jens Christian Hedemann Sørensen,
  • Kaare Meier,
  • Kamilla Truong,
  • Lasse Cramer Ahrens,
  • Thea Overgaard Wichmann,
  • Hamed Zaer,
  • Lasse Hubertus Tiroke,
  • Simon Arvin,
  • Mindaugas Bazys,
  • Peter Duel,
  • Gudrun Gudmundsdottir,
  • Jakob Gram Carlsen,
  • Mikkel Mylius Rasmussen

DOI
https://doi.org/10.1136/rmdopen-2024-004196
Journal volume & issue
Vol. 10, no. 2

Abstract

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Objective A comparison of cryoneurolysis or radio frequency (RF) with placebo in patients with facetogenic chronic low back pain (LBP) for patient global impression of change (PGIC), pain intensity, function and quality of life, with 1-year follow-up.Design Single-centre, single-blinded placebo-controlled randomised controlled trial.Setting Single-centre study.Participants Inclusion from March 2020 to September 2022: consenting adults over 18 years of age, LBP>3 months, average Numeric Rating Scale LBP≥4 average last 14 days and a positive response to a diagnostic medial branch block (>50% pain reduction after 60 min).Interventions 120 patients were block randomised 1:1:1 to cryoneurolysis, RF or placebo of the medial branch nerves. Physical therapy was added after 4 weeks for all groups.Main outcome measures Primary outcome was PGIC 4 weeks after the intervention. Secondary outcomes included pain intensity (Numeric Rating Scale, NRS), quality of life (Short Form 36, EQ-5D-5L), disability (Oswestry Disability Index), depression (Major Depression Inventory) and catastrophising (Pain Catastrophising Scale). Outcomes were measured at 4 weeks, 3, 6 and 12 months.Results There was no statistically significant difference in PGIC at 4 weeks between cryoneurolysis and placebo (risk ratio (RR) 2; 95% CI 0.75 to 5.33, p=0.17) and RF and placebo (RR 1.6; 95% CI 0.57 to 4.49, p=0.37), except PGIC for cryoneurolysis at 6-month follow-up (RR 5.1; 95% CI 1.20 to 22.03, p=0.03). No statistically significant differences were found in secondary follow-up endpoints.Conclusions 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.Trial registration number NCT04786145.