The Prevalence of Directional Preference in the Lumbar Stenosis Population

NCT07007663 | Recruiting

• 1 other identifier: 24-01830
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (7)

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

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

• Change in Pain Scores in LSS Patients With and Without DP

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

• Change in Pain Scores in LSS Patients With and Without DP

  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

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

• Change in PROMIS - Pain Interference Score in LSS Patients With and Without DP

  Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)

Study Arms (1)

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.

Eligibility Criteria

• Age: 48 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

Lake Success, New York, 11042, United States

RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• William Oswald, DPT

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bob Chang

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 6, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): June 9, 2027
• Study Completion (Estimated): June 9, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)