Lumbar Spinal Stenosis Clinical Trial
Official title:
Diagnostic Screening Tool for Lumbar Spinal Stenosis
The aim of this project is to develop a questionnaire that should distinguish patients with
lumbar spinal stenosis (LSS) from other patients. LSS can cause significant pain and
disability leading to dramatically reduced quality of life, immobility and functional
limitation.
The number of people with pain and disability due to LSS is expected to increase with age due
to the degenerative nature of the disease. With an aging population this could potentially
become a major health economic challenge.
One of the challenges to estimate the true prevalence is the lack of a valid and reliable
gold standard for LSS. To our knowledge, no diagnostic screening tool designed to estimate
the prevalence of LSS in a clinical population of Danish patients with chronic low back pain
(LBP) and leg pain has been developed.
The objective of this project is to develop a diagnostic screening tool for LSS - the LLS
Screen. This should consist of a set of items useable in a self-administered questionnaire, a
rule to compute the probability of having LSS, and a cutpoint to be used to obtain a
sensitivity of 95%. The rule should be applicable in patient populations suffering from low
back pain and with increased suspicion to suffer from LSS due to failure of non-surgical
treatment
The specific objectives are:
A. To identify items with high content validity for diagnosing LLS B. To investigate the
preliminary value of items included in the LLS screen C. To investigate the performance of
the included items in the LLS screen D. To decide on the content of the final version of the
LLS Screen
This project consists of four parts. Part I addresses objective A based on a literature
search and qualitative semi-structured interviews. Part II addresses objective B by
conducting a case-control study concurrent with a cohort study and performing a series of
analyses to investigate the preliminary value and performance of the items. Part III
describes the performance of the items by combining them in various ways to obtain an optimal
diagnostic rule (objective C). Finally, part IV is a decision of the content of the final
version of the LSS Screen based on information from Part I, II and III (objective D).
Part II:
A case-control study with cases and controls identified within a prospective clinical
population based cohort study that will be boosted with cases of LSS.
Cohort design First, a prospective clinical population based cohort of patients with low back
pain and/or leg pain will be initiated. Patients above 50 years of age will be included in
the study at their first visit at the Spine Centre where they fill out the screening
questionnaire (index test) before they are seen by a clinician. The primary diagnosis
(reference test) will be assessed and determined by specialists at the Spine Centre.
Case-control design Secondly, patients with LSS will be recruited from other departments to
artificially increase the prevalence of LSS. Patients with LSS will be recruited from the
surgical department at the Spine Centre of Southern Denmark, Middelfart, Denmark and
Department of Spine Surgery, Odense University Hospital (OUH), Odense, Denmark.
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