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Published in: BMC Musculoskeletal Disorders 1/2020

Open Access 01-12-2020 | Neck Pain | Study protocol

A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy

Authors: Mirad Taso, Jon Håvard Sommernes, Frode Kolstad, Jarle Sundseth, Siri Bjorland, Are Hugo Pripp, John Anker Zwart, Jens Ivar Brox

Published in: BMC Musculoskeletal Disorders | Issue 1/2020

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Abstract

Background

Cervical radiculopathy is usually caused by disc herniation or spondylosis. The prognosis is expected to be good in most patients, but there is limited scientific evidence on the indications for nonsurgical and surgical treatments. The aim of the present study is to evaluate and compare the effectiveness of surgical and nonsurgical treatment in two trials – including disc herniation and spondylosis, respectively, and to evaluate factors that contribute to better decision making.

Methods/design

Patients with disabling radicular arm pain and MRI-proven cervical disc herniation or spondylosis will be randomised to receive nonsurgical or surgical treatment. The follow-up period is one year and the sample size is estimated to be 50 for each arm in the two trials, giving a total of 200 patients. The primary outcomes are the Neck Disability Index and arm pain. Secondary outcomes include neck pain; EQ-5D and costs to evaluate cost-effectiveness; prognostic factors; CT and MRI scans, to estimate intervertebral foraminal area and nerve root compression; and the expected minimal improvement for willingness to undergo treatment.

Discussion

The outcomes of this study will contribute to better decision making in the treatment of cervical radiculopathy.

Trial registration

This study has been registered at ClinicalTrials.gov as NCT03674619, on September 17, 2018.
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Metadata
Title
A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy
Authors
Mirad Taso
Jon Håvard Sommernes
Frode Kolstad
Jarle Sundseth
Siri Bjorland
Are Hugo Pripp
John Anker Zwart
Jens Ivar Brox
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2020
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-020-3188-6

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