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Open Access Highly Accessed Study protocol

Cost-effectiveness of minimal interventional procedures for chronic mechanical low back pain: design of four randomised controlled trials with an economic evaluation

Esther T Maas1*, Johan NS Juch2, J George Groeneweg2, Raymond WJG Ostelo13, Bart W Koes4, Arianne P Verhagen4, Merel van Raamt5, Frank Wille6, Frank JPM Huygen2 and Maurits W van Tulder13

Author Affiliations

1 Department of Health Sciences and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, Amsterdam, The Netherlands

2 Department of Anaesthesiology, Erasmus Medical Centre, Rotterdam, The Netherlands

3 Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU, University Medical Center Amsterdam, Amsterdam, The Netherlands

4 Department of General Practice, Erasmus Medical Centre, Rotterdam, The Netherlands

5 Sport Medical Center Papendal, Arnhem, The Netherlands

6 Department of Anaesthesiology, Diakonessenhuis, Utrecht/Zeist, The Netherlands

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BMC Musculoskeletal Disorders 2012, 13:260  doi:10.1186/1471-2474-13-260

Published: 28 December 2012

Abstract

Background

Minimal interventional procedures are frequently applied in patients with mechanical low back pain which is defined as pain presumably resulting from single sources: facet, disc, sacroiliac joint or a combination of these. Usually, these minimal interventional procedures are an integral part of a multidisciplinary pain programme. A recent systematic review issued by the Dutch Health Insurance Council showed that the effectiveness of these procedures for the total group of patients with chronic low back pain is yet unclear and cost-effectiveness unknown. The aim of the study is to evaluate whether a multidisciplinary pain programme with minimal interventional procedures is cost-effective compared to the multidisciplinary pain programme alone for patients with chronic mechanical low back pain who did not respond to conservative primary care and were referred to a pain clinic.

Methods

All patients with chronic low back pain who are referred to one of the 13 participating pain clinics will be asked to participate in an observational study. Patients with a suspected diagnosis of facet, disc or sacroiliac joint problems will receive a diagnostic block to confirm this diagnosis. If confirmed, they will be asked to participate in a Randomized Controlled Trial (RCT). For each single source a separate RCT will be conducted. Patients with a combination of facet, disc or sacroiliac joint problems will be invited for participation in a RCT as well. An economic evaluation from a societal perspective will be performed alongside these four RCTs. Patients will complete questionnaires at baseline, 3 and 6 weeks, 3, 6, 9 and 12 months after start of the treatment. Costs will be collected using self-completed cost questionnaires.

Discussion

No trials are yet available which have evaluated the cost-effectiveness of minimal interventional procedures in patients with chronic mechanical low back pain, which emphasizes the importance of this study.

Trial registration number

National Trial Register: NTR3531

Keywords:
Chronic mechanical low back pain; Minimal interventional procedures; Multidisciplinary pain programme; Economic evaluation