Menu
Recruiting NCT07007663

The Prevalence of Directional Preference in the Lumbar Stenosis Population

— Observational Lumbar Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lumbar Stenosis. Basic parameters: from 48 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-center Observational Study Looking at the Prevalence of Directional Preference in the Lumbar Stenosis Population for Low Back Pain Patients

Overview

This will be a prospective cohort observational study observing patients with low back pain with leg pain who present for outpatient physical therapy care at Rusk Rehabilitation at NYU Langone Ambulatory Care Lake Success. Patients are eligible if they present with imaging of stenosis in their lumbar spine on MRI or CT Scan and note radicular leg symptoms with associated neurological deficits on the physical examination for at least 12 weeks.

Primary outcome measures

  • Prevalence of directional preference (DP) among patients diagnosed with lumbar spinal stenosis (LSS) [Time frame: Baseline]
  • Prevalence of DP among patients diagnosed with LSS [Time frame: Visit 3 (variable by participant; up to Day 365)]
Secondary outcome measures (7)
  • Prevalence of Specific Directions of Directional Preference (DP) in LSS Population [Time frame: Visit 3 (variable by participant; up to Day 365)]
  • Change in Pain Scores in LSS Patients With and Without DP [Time frame: Baseline, Visit 3 (variable by participant; up to Day 365)]
  • Change in Pain Scores in LSS Patients With and Without DP [Time frame: Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)]
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference Score in LSS Patients With and Without DP [Time frame: Baseline, Visit 3 (variable by participant; up to Day 365)]
  • Change in PROMIS - Pain Interference Score in LSS Patients With and Without DP [Time frame: Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)]
  • Change in PROMIS - Physical Function Score in LSS Patients With and Without DP [Time frame: Baseline, Visit 3 (variable by participant; up to Day 365)]
  • Change in PROMIS - Physical Function Score in LSS Patients With and Without DP [Time frame: Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)]

Eligibility criteria

Inclusion criteria

  • Neurogenic claudication (pain in the buttock, thigh, or leg during ambulation) or radicular leg symptoms with associated neurological deficits on the physical examination for at least 12 weeks.
  • Confirmatory cross-sectional magnetic resonance imaging (MRI) or computed tomography (CT) imaging demonstrating the presence of either central or lateral lumbar spinal stenosis at one or more levels was required.
  • Age >48 years old
  • Willing and able to consent
  • Scheduled to receive physical therapy that includes the collection of patients outcomes, functional tests, and may include the conduct of a two-stage treadmill test

Exclusion criteria

  • Radiographic evidence of instability, degenerative spondylolisthesis, fracture, or scoliosis of more than 15°.
  • Comorbid health conditions precluding surgical management, prior lumbar surgery, progressive neurological deficit, any inflammatory conditions such as rheumatoid arthritis or indication of a potential non-musculoskeletal spinal condition (e.g., active malignancy, infection, etc.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • NYU Langone Health — Lake Success

Identifiers

NCT: NCT07007663 · 24-01830

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗