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




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BMC Musculoskeletal Disorders

, 13:260

Epidemiology of musculoskeletal disorders

Abstract

BackgroundMinimal 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.

MethodsAll 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.

DiscussionNo 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 numberNational Trial Register: NTR3531

KeywordsChronic mechanical low back pain Minimal interventional procedures Multidisciplinary pain programme Economic evaluation AbbreviationsRCTRandomized controlled trial

SI-jointSacroiliac joint

CVZHealth insurance council

IASPInternational association for the study of pain

ISISInternational spinal injection society

4DSQFour-dimensional symptoms questionnaire

CPAQChronic pain acceptance questionnaire

HADSHospital anxiety depression scale

PCIPain coping inventory

PCLPain cognition list

LLumbar vertebrae

IDETIntradiscal electrothermal therapy

QALYQuality adjusted life years

CEQCredibility-expectancy questionnaire

NRSNumerical rating scale

ODIOswestry disability index

EQ-5DEuroQol

MPIMultidimensional pain inventory

PRODISCProductivity and disease questionnaire

SDStandard deviation.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2474-13-260 contains supplementary material, which is available to authorized users.

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Author: Esther T Maas - Johan NS Juch - J George Groeneweg - Raymond WJG Ostelo - Bart W Koes - Arianne P Verhagen - Merel va

Source: https://link.springer.com/







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