Design of the Verbiest trial: cost-effectiveness of surgery versus prolonged conservative treatment in patients with lumbar stenosis

BMC Musculoskeletal Disorders

Study Protocol

Bart W Koes¹  Pim AJ Luijsterburg¹  Sita MA Bierma-Zeinstra²  Just AH Eekhof³  Ronald Brand⁴  Carmen LAM Vleggeert-Lankamp⁵  Wilco C Peul⁶  Gijsbert M Overdevest⁶ 

[1] Department of General Practice, Erasmus MC, University Medical Center, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands;Department of General Practice, Erasmus MC, University Medical Center, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands;Department of Orthopaedic Surgery, Erasmus MC, University Medical Center, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands;Department of General Practice, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands;Department of Medical Statistics, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands;Department of Neurosurgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands;Department of Neurosurgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands;Department of Neurosurgery, Medical Center Haaglanden, Lijnbaan 32, 2512 VA, The Hague, The Netherlands;

关键词: Physical Therapist;    Spinal Stenosis;    Lumbar Spinal Stenosis;    Minimal Clinically Import Difference;    Roland Morris Disability Questionnaire;   

DOI  :  10.1186/1471-2474-12-57

 received in 2011-02-14, accepted in 2011-03-03,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundDegenerative changes of lumbar spine anatomy resulting in the encroachment of neural structures are often regarded progressive, ultimately necessitating decompressive surgery. However the natural course is not necessarily progressive and the efficacy of a variety of nonsurgical interventions has also been described. At present there is insufficient data to compare surgical and nonsurgical interventions in terms of their relative benefit and safety. Previous attempts failed to provide clear clinical recommendations or to distinguish subgroups that substantially benefit from a certain treatment strategy. We present the design of a randomized controlled trial on (cost-) effectiveness of surgical decompression versus prolonged conservative treatment in patients with neurogenic intermittent claudication caused by lumbar stenosis.Methods/DesignThe aim of the Verbiest trial is to evaluate the effectiveness of prolonged conservative treatment compared to decompressive surgery. The study is a multi-center randomized controlled trial with two parallel groups design. Patients (age over 50) presenting to the neurologist or neurosurgeon with at least 3 months complaints of neurogenic intermittent claudication and considering surgical treatment are eligible for inclusion. Participants are randomly allocated to either prolonged conservative treatment, receiving further treatment from their general practitioner and physical therapist, or allocated to surgery and operated within 4 weeks. Primary outcome measure is the functional assessment of the patient as measured by the Zurich Claudication Questionnaire at 24 months of follow-up. Data is analyzed according to the intention to treat principle.DiscussionWith a cost-effectiveness analysis the trade off between the costs of prolonged conservative treatment and delayed surgery in a smaller number of patients are compared with the current policy of surgical management. As surgery is expected to be inevitable in certain subgroups of patients, the distinction of and classification by predictive patient characteristics is most relevant to clinical practice.Trial registrationNetherlands Trial Register (NTR): NTR2216

【 授权许可】

CC BY   
© Overdevest et al; licensee BioMed Central Ltd. 2011