Design of the Verbiest trial
| Autor: | Pim A J Luijsterburg, Sita M A Bierma-Zeinstra, Ronald Brand, Bart W. Koes, Carmen L.A.M. Vleggeert-Lankamp, Wilco C. Peul, Gijsbert M. Overdevest, Just A.H. Eekhof |
|---|---|
| Přispěvatelé: | Radiology & Nuclear Medicine, General Practice |
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Male
medicine.medical_specialty lcsh:Diseases of the musculoskeletal system Cost effectiveness Spinal stenosis Cost-Benefit Analysis Lumbar vertebrae Motor Activity law.invention Study Protocol Spinal Stenosis Rheumatology Randomized controlled trial law Outcome Assessment Health Care medicine Humans Orthopedics and Sports Medicine Physical Therapy Modalities Aged Netherlands Pain Measurement Aged 80 and over Lumbar Vertebrae Intention-to-treat analysis business.industry Middle Aged Decompression Surgical medicine.disease Intermittent claudication Surgery Treatment Outcome medicine.anatomical_structure Orthopedic surgery Physical therapy Female medicine.symptom lcsh:RC925-935 low-back-pain quality-of-life spinal stenosis physical-activity nonoperative treatment natural-history outcome measure primary care questionnaire trends Claudication business Follow-Up Studies |
| Zdroj: | BMC Musculoskeletal Disorders, 12 BMC Musculoskeletal Disorders, Vol 12, Iss 1, p 57 (2011) BMC Musculoskeletal Disorders, 12:57. BioMed Central Ltd. BMC Musculoskeletal Disorders |
| ISSN: | 1471-2474 |
| DOI: | 10.1186/1471-2474-12-57 |
| Popis: | Background Degenerative 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/Design The 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. Discussion With 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 registration Netherlands Trial Register (NTR): NTR2216 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink