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Published in: BMC Musculoskeletal Disorders 1/2014

Open Access 01-12-2014 | Study protocol

CASINO: Surgical or Nonsurgical Treatment for cervical radiculopathy, a randomised controlled trial

Authors: Sarita van Geest, Barbara Kuijper, Marinus Oterdoom, Wilbert van den Hout, Ronald Brand, Theo Stijnen, Pim Assendelft, Bart Koes, Wilco Jacobs, Wilco Peul, Carmen Vleggeert-Lankamp

Published in: BMC Musculoskeletal Disorders | Issue 1/2014

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Abstract

Background

Cervical radicular syndrome (CRS) due to a herniated disc can be safely treated by surgical decompression of the spinal root. In the vast majority of cases this relieves pain in the arm and restores function. However, conservative treatment also has a high chance on relieving symptoms. The objective of the present study is to evaluate the (cost-) effectiveness of surgery versus prolonged conservative care during one year of follow-up, and to evaluate the timing of surgery. Predisposing factors in favour of one of the two treatments will be evaluated.

Methods/design

Patients with disabling radicular arm pain, suffering for at least 2 months, and an MRI-proven herniated cervical disc will be randomised to receive either surgery or prolonged conservative care with surgery if needed. The surgical intervention will be an anterior discectomy or a posterior foraminotomy that is carried out according to usual care. Surgery will take place within 2–4 weeks after randomisation. Conservative care starts immediately after randomisation. The primary outcome measure is the VAS for pain or tingling sensations in the arm one year after randomisation. In addition, timing of surgery will be studied by correlating the primary outcome to the duration of symptoms. Secondary outcome measures encompass quality of life, costs and perceived recovery. Predefined prognostic factors will be evaluated. The total follow-up period will cover two years. A sample size of 400 patients is needed. Statistical analysis will be performed using a linear mixed model which will be based on the ‘intention to treat’ principle. In addition, a new CRS questionnaire for patients will be developed, the Leiden Cervical Radicular Syndrome Functioning (LCRSF) scale.

Discussion

The outcome will contribute to better decision making for the treatment of cervical radicular syndrome.

Trial registration

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Metadata
Title
CASINO: Surgical or Nonsurgical Treatment for cervical radiculopathy, a randomised controlled trial
Authors
Sarita van Geest
Barbara Kuijper
Marinus Oterdoom
Wilbert van den Hout
Ronald Brand
Theo Stijnen
Pim Assendelft
Bart Koes
Wilco Jacobs
Wilco Peul
Carmen Vleggeert-Lankamp
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2014
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-15-129

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