Diagnostic Screening Tool for Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

— LSS Screen  

Official title:

Diagnostic Screening Tool for Lumbar Spinal Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03910335
• Other study ID #: 10.180
• Status: Completed
• Start date: February 19, 2019
• Est. completion date: October 23, 2019

Study information

• Verified date: February 2020
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: October 23, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Able to read and write Danish

• Age above 50

• Low back pain and/or leg pain

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Diagnostic Test:
• LSS Screen
Patients will fill out a questionnaire with 13 questions related to presence or absence of clinical symptoms of lumbar spinal stenosis (neurogenic claudication)

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of the screening questionnaire for lumbar spinal stenosis (LLS screen)	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.	Baseline

External Links

•   Full project protocol