How common a directional preference is in people with lumbar spinal stenosis

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

We will see if people over 48 with MRI- or CT-confirmed lumbar spinal stenosis and ongoing leg pain show a movement or position that consistently reduces their symptoms during outpatient physical therapy.

Quick facts

• Study type: Observational
• Enrollment: 67 (estimated)
• Ages: 48 Years and up
• Sex: All
• Sponsor: NYU Langone Health (other)
• Locations: 1 site (Lake Success, New York)
• Trial ID: NCT07007663 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort of patients with low back and radicular leg pain who present for outpatient physical therapy at Rusk Rehabilitation at NYU Langone Ambulatory Care Lake Success. Eligible participants are over 48, have radicular leg symptoms with neurological deficits for at least 12 weeks, and imaging (MRI or CT) confirming central or lateral lumbar spinal stenosis. Physical therapy sessions will include routine outcome measures, functional tests, and may include a two-stage treadmill test while clinicians note whether the patient demonstrates a directional preference (a movement or position that reduces symptoms). The study will describe how often directional preference occurs and relate it to imaging findings and clinical exam features without changing standard clinical care.

Who should consider this trial

Good fit: Ideal candidates are adults over 48 with MRI/CT-confirmed lumbar stenosis and at least 12 weeks of radicular leg symptoms who are scheduled for outpatient physical therapy and can give informed consent.

Not a fit: Patients with radiographic instability, significant spondylolisthesis, prior lumbar surgery, progressive neurological deficit, inflammatory arthritis, or medical comorbidities that preclude surgical management are excluded and are unlikely to benefit from the study’s findings.

Why it matters

Potential benefit: If a directional preference is common, therapists could use that information to better tailor exercises and positioning to reduce symptoms and improve walking for patients with lumbar stenosis.

How similar studies have performed: Directional preference approaches (for example McKenzie methods) have shown benefit in some back pain populations but have limited and mixed evidence specific to lumbar spinal stenosis.

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.)

Where this trial is running

Lake Success, New York

• NYU Langone Health — Lake Success, New York, United States (RECRUITING)

Study contacts

• Principal investigator: William Oswald, DPT — NYU Langone Health
• Study coordinator: Bob Chang

Conditions: Lumbar Stenosis