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NCT Number: NCT07007663

The Prevalence of Directional Preference in the Lumbar Stenosis Population

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.

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Key information

Conditions

LUMBAR STENOSIS Constriction, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

48 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

Lake Success, New York, 11042, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. Prevalence of directional preference (DP) among patients diagnosed with lumbar spinal stenosis (LSS)

    Time frame: Baseline

    Prevalence is calculated as the proportion of patients with DP out of the total sample of LSS patients.

  2. Prevalence of DP among patients diagnosed with LSS

    Time frame: 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.

Secondary outcomes

  1. Prevalence of Specific Directions of Directional Preference (DP) in LSS Population

    Time frame: Visit 3 (variable by participant; up to Day 365)

    Percentage of patients with LSS demonstrating each primary DP movement direction (FLEXION, EXTENSION, or LATERAL).

  2. Change in Pain Scores in LSS Patients With and Without DP

    Time frame: Baseline, Visit 3 (variable by participant; up to Day 365)

    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.

  3. 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)

    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.

  4. 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)

    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.

  5. 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)

    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.

  6. 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)

    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.

  7. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bob Chang

CONTACT

[email protected]

516-467-8731

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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