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Diagnostic Screening Tool for Lumbar Spinal Stenosis

NCT03910335 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 383

Last updated 2020-02-11

No results posted yet for this study

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

Conditions

  • Lumbar Spinal Stenosis

Interventions

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)

Sponsors & Collaborators

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Rikke K Jensen, PhD · University of Southern Denmark (SDU)

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2019-06-28
Completion
2019-10-23

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03910335 on ClinicalTrials.gov