Evidence map›Paper›PMID 38724261›Full record

Trial reportRMD open2024

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

Kamilla Truong, Kaare Meier, Lasse Cramer Ahrens, Thea Overgaard Wichmann, Hamed Zaer, Lasse Hubertus Tiroke, Simon Arvin, Mindaugas Bazys, Peter Duel, Gudrun Gudmundsdottir and 5 more

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in RMD open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04786145 (Cryoneurolysis Outcome on Pain Experience), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04786145 naunknown statusnot on this map

Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain - a Single-blinded Randomized Controlled Trial

TypeinterventionalSponsorUniversity of AarhusRan2020 to 2022Enrolled120ConditionsChronic Low-back Pain, Facet Joint Pain, Degeneration Lumbar Spine, Facet Joint SyndromeArmsCryoneurolysis, Radiofrequency ablation, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Review
  5. Article
  6. Observational
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Kamilla TruongDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Kaare MeierCenter for Experimental Neuroscience (CENSE) and CENSE-spine, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Lasse Cramer AhrensDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Thea Overgaard WichmannDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Hamed ZaerDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Lasse Hubertus TirokeDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Simon ArvinDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Mindaugas BazysDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Peter DuelDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Gudrun GudmundsdottirDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Jakob Gram CarlsenDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Lone NikolajsenDepartment of Anesthesiology, Aarhus University Hospital, Aarhus, Denmark.
Maurits van TulderDepartment of Human Movement Sciences, Faculty of Behavioral and Movement Sciences, Vrije Universiteit, Amsterdam, The Netherlands.
Jens Christian Hedemann SørensenDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Mikkel Mylius RasmussenDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark mikkrasm@rm.dk.ORCID 0000-0002-4768-7255

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveA 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.

designSingle-centre, single-blinded placebo-controlled randomised controlled trial.

settingSingle-centre study.

participantsInclusion 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 (

interventions120 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 measuresPrimary 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.

resultsThere 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.

conclusionsDenervation 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.

Indexed as

Chronic PainLow Back PainPain MeasurementQuality of LifeRadiofrequency AblationAdultAgedCryosurgeryFemaleHumansMaleMiddle AgedPain ManagementSingle-Blind MethodTreatment OutcomeLow Back PainOrthopedic ProceduresPainPatient Reported Outcome Measures

Identifiers

PMID38724261
PMCPMC11086270

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.