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.
Keywords: Anterior cervical decompression and fusion; Cervical radiculopathy; Effectiveness; Nonsurgical; Physical medicine and rehabilitation; RCT; Shared decision making; Surgery; Treatment.