Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT07007663

Conditions

Lumbar Stenosis

Eligibility Criteria

Sex: All

Age: 48+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Lumbar Stenosis

Study ID

NCT07007663

Start date

Jun 9, 2025

Status verified date

Apr, 2026

Completion date

Jun 9, 2027

Anticipated

Primary completion date

Jun 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 48+

Healthy Volunteers: Not accepted

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

Enrollment

67 participants

Anticipated

Interventions and Outcome Measures

Arms

Lumbar stenosis patients

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Bob Chang

516-467-8731Bob.chang@nyulangone.org

Locations

NYU Langone Health

Recruiting

Lake Success, New York, United States, 11042

More Information

Sponsor

NYU Langone Health

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-04.