Diagnostic Screening Tool for Lumbar Spinal Stenosis
LSS Screen
1 other identifier
observational
383
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2019
CompletedFirst Submitted
Initial submission to the registry
April 5, 2019
CompletedFirst Posted
Study publicly available on registry
April 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2019
CompletedFebruary 11, 2020
February 1, 2020
4 months
April 5, 2019
February 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
LSS patients
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)
Non-LSS patients
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)
Interventions
Patients will fill out a questionnaire with 13 questions related to presence or absence of clinical symptoms of lumbar spinal stenosis (neurogenic claudication)
Eligibility Criteria
Case/control design: 90-100 cases will be collected at surgical departments from patients assigned to surgery due to clinical symptoms of lumbar spinal stenosis Cohort design: Patients reffered from primary care to a publicly-funded outpatient secondary care spine clinic with primary compain of low back pain and/or leg pain
You may qualify if:
- Able to read and write Danish
- Age above 50
- Low back pain and/or leg pain
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern Denmark
Odense, 5230, Denmark
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rikke K Jensen, PhD
University of Southern Denmark (SDU)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2019
First Posted
April 10, 2019
Study Start
February 19, 2019
Primary Completion
June 28, 2019
Study Completion
October 23, 2019
Last Updated
February 11, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share