Clinical trial NCT07007663: The Prevalence of Directional Preference in the Lumbar Stenosis Population
Official title: A Single-center Observational Study Looking at the Prevalence of Directional Preference in the Lumbar Stenosis Population for Low Back Pain Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Stenosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 67
Sex: ALL
Minimum age (years): 48
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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.)

Primary outcomes:
measure: Prevalence of directional preference (DP) among patients diagnosed with lumbar spinal stenosis (LSS)
timeFrame: Baseline
measure: Prevalence of DP among patients diagnosed with LSS
timeFrame: Visit 3 (variable by participant; up to Day 365)
Secondary outcomes:
measure: Prevalence of Specific Directions of Directional Preference (DP) in LSS Population
timeFrame: Visit 3 (variable by participant; up to Day 365)
measure: Change in Pain Scores in LSS Patients With and Without DP
timeFrame: Baseline, Visit 3 (variable by participant; up to Day 365)
measure: Change in Pain Scores in LSS Patients With and Without DP
timeFrame: Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference Score in LSS Patients With and Without DP
timeFrame: Baseline, Visit 3 (variable by participant; up to Day 365)
measure: Change in PROMIS - Pain Interference Score in LSS Patients With and Without DP
timeFrame: Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)
measure: Change in PROMIS - Physical Function Score in LSS Patients With and Without DP
timeFrame: Baseline, Visit 3 (variable by participant; up to Day 365)
measure: Change in PROMIS - Physical Function Score in LSS Patients With and Without DP
timeFrame: Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: William Oswald, DPT
role: PRINCIPAL_INVESTIGATOR
References: