Evidence map›Paper›PMID 36512721›Full record

Trial reportAnesthesiology2023

Ultrasound-guided Percutaneous Cryoneurolysis to Treat Chronic Postamputation Phantom Limb Pain: A Multicenter Randomized Controlled Trial.

Brian M Ilfeld, Cameron R Smith, Alparslan Turan, Edward R Mariano, Matthew E Miller, Rick L Fisher, Andrea M Trescot, Steven P Cohen, James C Eisenach, Daniel I Sessler and 5 more

Open access · bronzeAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Anesthesiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
7.6field-weighted citation impact, top 2% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

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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 at 2 institutions in 4 countries.

Brian M IlfeldDepartment of Anesthesiology' University of California San Diego' San Diego' California.ORCID 0000-0002-6144-3273
Cameron R SmithDepartment of Anesthesiology' University of Florida' Gainesville' Florida.
Alparslan TuranDepartments of General Anesthesia and Outcomes Research' Cleveland Clinic' Cleveland' Ohio.
Edward R MarianoDepartment of Anesthesiology, Perioperative and Pain Medicine' Palo Alto Veterans Affairs' Palo Alto' California.
Matthew E MillerDepartment of Anesthesiology' Walter Reed National Military Medical Center' Bethesda' Maryland.
Rick L FisherDepartment of Anesthesiology' Naval Medical Center San Diego' San Diego' California.
Andrea M TrescotFlorida Pain Relief Group' Tampa' Florida.
Steven P CohenDepartment of Anesthesiology' Johns Hopkins' Baltimore' Maryland.
James C EisenachDepartment of Anesthesiology' Wake Forest School of Medicine' Winston-Salem' North Carolina.
Daniel I SesslerDepartment of Outcomes Research' Cleveland Clinic' Cleveland' Ohio.
J David PrologoDepartment of Radiology' Emory University' Atlanta' Georgia.
Edward J MaschaDepartments of Quantitative Health Sciences and Outcomes Research' Cleveland Clinic' Cleveland' Ohio.
Liu LiuDepartments of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, Ohio.ORCID 0000-0003-2426-7044
Rodney A GabrielDepartment of Anesthesiology' University of California San Diego' San Diego' California.
PAINfRE Investigators
Apple (Israel) · ILNaval Medical Center San Diego · US

Funding

UC San Diego Clinical and Translational Research InstituteUL1TR001442 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S, HOGARTH, MICHAEL · 2015 to 2024
$88.3M
NCATS NIH HHS UL1 TR001442
6 · The paper itself

Abstract

backgroundPostamputation phantom pain is notoriously persistent with few validated treatments. Cryoneurolysis involves the application of low temperatures to reversibly ablate peripheral nerves. The authors tested the hypothesis that a single cryoneurolysis treatment would decrease phantom pain 4 months later.

methodsThe authors enrolled patients with a lower-limb amputation and established phantom pain. Each received a single-injection femoral and sciatic nerve block with lidocaine and was subsequently randomized to receive either ultrasound-guided percutaneous cryoneurolysis or sham treatment at these same locations. The primary outcome was the change in average phantom pain intensity between baseline and 4 months as measured with a numeric rating scale (0 to 10), after which an optional crossover treatment was offered. Investigators, participants, and clinical staff were masked to treatment group assignment with the exception of the treating physician performing the cryoneurolysis, who had no subsequent participant interaction.

resultsPretreatment phantom pain scores were similar in both groups, with a median [quartiles] of 5.0 [4.0, 6.0] for active treatment and 5.0 [4.0, 7.0] for sham. After 4 months, pain intensity decreased by 0.5 [-0.5, 3.0] in patients given cryoneurolysis (n = 71) versus 0 [0, 3] in patients given sham (n = 73), with an estimated difference (95% CI) of -0.1 (-1.0 to 0.7), P = 0.759. Following their statistical gatekeeping protocol, the authors did not make inferences or draw conclusions on secondary endpoints. One serious adverse event occurred after a protocol deviation in which a femoral nerve cryolesion was induced just below the inguinal ligament-instead of the sensory-only saphenous nerve-which resulted in quadriceps weakness, and possibly a fall and clavicle fracture.

conclusionsPercutaneous cryoneurolysis did not decrease chronic lower extremity phantom limb pain 4 months after treatment. However, these results were based upon the authors' specific study protocol, and since the optimal cryoneurolysis treatment parameters such as freeze duration and anatomic treatment location remain unknown, further research is warranted. EDITOR’S PERSPECTIVE:

Indexed as

Nerve BlockPhantom LimbCold TemperatureHumansLidocaineUltrasonography, InterventionalLidocaine

Identifiers

PMID36512721
PMCPMC10374196
OpenAlexW4309648772

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.