Diagnostic Screening Tool for Lumbar Spinal Stenosis

Completed

• Conditions: Lumbar Spinal Stenosis
• Interventions: Diagnostic Test: LSS Screen

• Registration Number: NCT03910335
• Lead Sponsor: University of Southern Denmark

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-02-19
• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Primary Completion: 2019-06-28
• Study Completion: 2019-10-23
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 383

Inclusion Criteria

• Able to read and write Danish
• Age above 50
• Low back pain and/or leg pain

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-LSS patients	LSS Screen	Case/control study and cohort study: Patients from a medical department will fill out the questionnaire, and a clinician will determine if LSS is present (reference standard)
LSS patients	LSS Screen	Case/control study: Patients from surgical departments awaiting surgery for LSS will will out the questionnaire. Cohort study: Patients from a medical department will fill out the questionnaire, and a clinician will determine if LSS is present (reference standard)

Primary Outcome Measures

Name	Time	Method
Accuracy of the screening questionnaire for lumbar spinal stenosis (LLS screen)	Baseline	To estimate the accuracy of the questionnaire LSS Screens ability to identify patients with clinical symptoms of LSS in terms of sensitivity, specificity and diagnostic odds ratio.

Trial Locations

Locations (1)

University of Southern Denmark; 🇩🇰 Odense, Denmark