Evidence map›Paper›PMID 39167110›Full record

Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2024

Cervical orthosis does not improve postoperative pain following posterior cervical fusion: a randomized controlled trial.

Renan Fernandes, Patrick Thornley, Jennifer Urquhart, Abdulmajeed Alahmari, Nasser Alenezi, Sean Kelly, Parham Rasoulinejad, Supriya Singh, Fawaz Siddiqi, Kevin Gurr and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04308122 (A Randomized Trial of Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT04308122 nacompletednot on this map

A Randomized Trial of Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion

TypeinterventionalSponsorDr. Christopher BaileyRan2020 to 2022Enrolled64ConditionsPosterior Cervical Spinal Surgery, Myelopathy Cervical, Radiculopathy, Cervical, Spinal Stenosis CervicalArmsCervical Orthosis (CO), No Orthosis
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

11 authors.

Renan FernandesCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada.
Patrick ThornleyCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada.
Jennifer UrquhartCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada. Jennifer.Urquhart@lhsc.on.ca.ORCID http://orcid.org/0000-0002-9393-814X
Abdulmajeed AlahmariCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada.
Nasser AleneziCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada.
Sean KellyCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada.
Parham RasoulinejadCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada.
Supriya SinghCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada.
Fawaz SiddiqiCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada.
Kevin GurrCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada.
Chris BaileyCombined Orthopaedic and Neurosurgical Spine Program, London, ON, Canada.

Funding

Lawson Health Research Institute IRF-21-20
6 · The paper itself

Abstract

purposeTo determine whether postoperative neck pain in the first 4 weeks following multi-level posterior cervical fusion (PCF) with orthosis is equivalent to multi-level PCF without orthosis.

methodsPatients were randomly assigned in a 1:1 ratio to postoperative orthosis (CO) for 6 weeks or no orthosis (NO). Randomization was stratified by indication (traumatic vs. degenerative), and preoperative opioid use. A model of longitudinal regression for repeated measures was used. The two-sided 95% confidence interval (CI) was used to test equivalence. If the CI lay between the pre-determined margin of equivalence (-2.0 to + 2.0 pain score) the two groups were considered equivalent. A multiple imputation procedure was used to replace missing data.

resultsThirty-one patients were enrolled in each group. At baseline, the CO group had more neck pain (5.3 vs. 3.2, p = 0.013). The Four week post-operative neck pain intensity score was 4.6 ± 0.3 for the CO group vs. 4.9 ± 0.3 for the NO group. The 95% confidence interval (-1.2 to 0.6) was within the pre-determined equivalence margin. Neck Disability Index, quality-of-life scores, and arm pain were similar. Eleven patients in the CO group and 12 patients in the NO group had an adverse event. The CO group had reduced range of motion at 6 weeks.

conclusionPain scores over the first 4 weeks after surgery were equivalent for patients undergoing multi-level PCF treated with or without a cervical orthosis. Our findings do not support the routine use of a postoperative cervical orthosis for postoperative pain control. Clinical Trials Registration Number NCT04308122, April 22, 2020.

Indexed as

Cervical VertebraeNeck PainOrthotic DevicesPostoperative PainSpinal FusionAdultAgedFemaleHumansMaleMiddle AgedPain MeasurementTreatment OutcomeBraceCervicalCollarEquivalenceOutcomesPainRange of motionSpineSurgery

Identifiers

PMID39167110

What OpenQuestion holds

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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.