Lumbar StenosisNCT07007663
The Prevalence of Directional Preference in the Lumbar Stenosis Population
An observational study of Lumbar Stenosis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 years and older
- Conditions the study is for
- Lumbar Stenosis
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to 9 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
Lake Success, New York, 11042
About this study
Official title: A Single-center Observational Study Looking at the Prevalence of Directional Preference in the Lumbar Stenosis Population for Low Back Pain Patients
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
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Visit 3 (variable by participant; up to Day 365)
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start9 Jun 2025
- Primary completion9 Jun 2027 (estimated)
- Study completion9 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar StenosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Oswald, DPT, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007663
- Sponsor's protocol ID
- 24-01830
- Status last verified
- Apr 2026
- First submitted
- 28 May 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Observational Study Looking at the Prevalence of Directional Preference in the Lumbar Stenosis Population for Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT07007663
- Acronym / sponsor ID
- 24-01830
- Conditions
- Lumbar Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 9 Jun 2027 (estimated)
- Study completion
- 9 Jun 2027 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 48 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of directional preference (DP) among patients diagnosed with lumbar spinal stenosis (LSS)
Time frame: Baseline
Prevalence is calculated as the proportion of patients with DP out of the total sample of LSS patients.
Prevalence of DP among patients diagnosed with LSS
Time frame: Visit 3 (variable by participant; up to Day 365)
Prevalence is calculated as the proportion of patients with DP out of the total sample of LSS patients.
7 secondary outcomes
Prevalence of Specific Directions of Directional Preference (DP) in LSS Population
Time frame: Visit 3 (variable by participant; up to Day 365)
Change in Pain Scores in LSS Patients With and Without DP
Time frame: Baseline, Visit 3 (variable by participant; up to Day 365)
Change in Pain Scores in LSS Patients With and Without DP
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
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
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
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
Time frame: Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Oswald, DPT principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Stenosis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bob Chang (516-467-8731, Bob.chang@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of directional preference (DP) among patients diagnosed with lumbar spinal stenosis (LSS) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.