Open Access Study protocol

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

Sarita van Geest1, Barbara Kuijper2, Marinus Oterdoom3, Wilbert van den Hout4, Ronald Brand5, Theo Stijnen6, Pim Assendelft7, Bart Koes5, Wilco Jacobs1, Wilco Peul1 and Carmen Vleggeert-Lankamp1*

Author Affiliations

1 Department of Neurosurgery, Leiden University Medical Center (LUMC), P.O. Box 9600, NL-2300 RC Leiden, the Netherlands

2 Department of Neurology, Maasstad Hospital Rotterdam, Rotterdam, the Netherlands

3 Department of Neurosurgery, Martini Hospital, Groningen, the Netherlands

4 Department of Medical Decision Making, LUMC, Leiden, the Netherlands

5 Department of Medical Statistics, LUMC, Leiden, the Netherlands

6 Department of Primary and Community care, Radboud University Hospital Nijmegen, Nijmegen, the Netherlands

7 Department of General Practice, University Medical Centre Rotterdam, Rotterdam, the Netherlands

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BMC Musculoskeletal Disorders 2014, 15:129  doi:10.1186/1471-2474-15-129

Published: 14 April 2014

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

NTR3504

Keywords:
Cervical herniated disc; Cervical radicular syndrome; Anterior discectomy; Foraminotomy; Cost-effectiveness; Conservative treatment; Randomized controlled trial; Shared decision making