An observational study in Lumbar Stenosis, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 48 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by NYU Langone Health · Observational
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.
456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.
This study's planned enrollment of 67 is below the median of 84 across 144 observational studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients that choose to participate are undergoing a course of outpatient physical therapy care on their own accord with a referral to physical therapy. The participants have the ability to drop out or withdraw at any point of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing physical therapy treatment at an outpatient clinic will be enrolled. Data collection will include patient outcome measures, if directional preference is present and results from the functional tests performed by 3 licensed physical therapists who also hold their diploma in the McKenzie Method of Mechanical Diagnosis and Therapy (specialized training in recognizing directional preference) as a part of routine care (not research) for the enrolled patients. Data will be collected at initial onset, at discharge, and at a 6 months follow up.
Prevalence of directional preference (DP) among patients diagnosed with lumbar spinal stenosis (LSS)
Prevalence is calculated as the proportion of patients with DP out of the total sample of LSS patients.
Time frame: Baseline
Prevalence of DP among patients diagnosed with LSS
Prevalence is calculated as the proportion of patients with DP out of the total sample of LSS patients.
Time frame: Visit 3 (variable by participant; up to Day 365)
Prevalence of Specific Directions of Directional Preference (DP) in LSS Population
Percentage of patients with LSS demonstrating each primary DP movement direction (FLEXION, EXTENSION, or LATERAL).
Time frame: Visit 3 (variable by participant; up to Day 365)
Change in Pain Scores in LSS Patients With and Without DP
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.
Time frame: Baseline, Visit 3 (variable by participant; up to Day 365)
Change in Pain Scores in LSS Patients With and Without DP
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.
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
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.
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
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.
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
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.
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
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.
Time frame: Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)
Plan to share: No
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