Lumbar Spinal Stenosis Clinical Trial
— LSS ScreenOfficial title:
Diagnostic Screening Tool for Lumbar Spinal Stenosis
NCT number | NCT03910335 |
Other study ID # | 10.180 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 19, 2019 |
Est. completion date | October 23, 2019 |
Verified date | February 2020 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | University of Southern Denmark | Odense |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark |
Denmark,
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 |
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