The Prevalence of Directional Preference in the Lumbar Stenosis Population

Recruiting

• Conditions: Lumbar Stenosis

• Registration Number: NCT07007663
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Status Verified: 2025-06
• Study First Posted: 2025-06-06
• Study Start: 2025-06-09
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-06-09
• Study Completion: 2026-06-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 67

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of DP among patients diagnosed with LSS	Visit 3 (variable by participant; up to Day 365)	Prevalence is calculated as the proportion of patients with DP out of the total sample of LSS patients.
Prevalence of directional preference (DP) among patients diagnosed with lumbar spinal stenosis (LSS)	Baseline	Prevalence is calculated as the proportion of patients with DP out of the total sample of LSS patients.

Secondary Outcome Measures

Name	Time	Method
Prevalence of Specific Directions of Directional Preference (DP) in LSS Population	Visit 3 (variable by participant; up to Day 365)	Percentage of patients with LSS demonstrating each primary DP movement direction (FLEXION, EXTENSION, or LATERAL).
Change in Pain Scores in LSS Patients With and Without DP	Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)	Pain is measured using the Numeric Pain Rating Scale (NPRS), a self-report scale where individuals rate their pain level on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference Score in LSS Patients With and Without DP	Baseline, Visit 3 (variable by participant; up to Day 365)	The PROMIS Pain Interference questionnaire is a 40-item measure of the extent to which pain interferes with various aspects of a person's life. Each item is rated on a Likert scale from 1-5; the raw score is the sum of item responses. The raw score is standardized into an overall T-score ranging from 0-100, with a mean of 50 and standard deviation of 10. Higher scores indicate greater pain interference.
Change in PROMIS - Pain Interference Score in LSS Patients With and Without DP	Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)	The PROMIS Pain Interference questionnaire is a 40-item measure of the extent to which pain interferes with various aspects of a person's life. Each item is rated on a Likert scale from 1-5; the raw score is the sum of item responses. The raw score is standardized into an overall T-score ranging from 0-100, with a mean of 50 and standard deviation of 10. Higher scores indicate greater pain interference.
Change in PROMIS - Physical Function Score in LSS Patients With and Without DP	Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)	The PROMIS Physical Function questionnaire is a 165-item measure of a patient's self-reported capability to perform functional activities, including activities of daily living (ADLs) and activities in the community. Each item is rated on a Likert scale from 1-5; the raw score is the sum of item responses. The raw score is standardized into an overall T-score ranging from 0-100, with a mean of 50 and standard deviation of 10. Higher scores indicate greater physical function.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 Lake Success, New York, United States