The Prevalence of Directional Preference in the Lumbar Stenosis Population
ConditionLumbar Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age48+
SponsorNYU Langone Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
67 Participants
are grouped into 1 trial groupGroup A: Lumbar stenosis patients
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Visit 3 (variable by participant; up to Day 365)Secondary outcomes
1
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).
Time frame
Visit 3 (variable by participant; up to Day 365)2
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.
Time frame
Baseline, Visit 3 (variable by participant; up to Day 365)3
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.
Time frame
Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months)4
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.
Time frame
Baseline, Visit 3 (variable by participant; up to Day 365)Sponsors and contacts
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Source ClinicalTrials.gov