A Single-center Observational Study Looking at the Prevalence of Directional Preference in the Lumbar Stenosis Population for Low Back Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Prevalence of directional preference (DP) among patients diagnosed with lumbar spinal stenosis (LSS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 48 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
研究组 & 干预措施
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.
结局指标
主要结局
Prevalence of directional preference (DP) among patients diagnosed with lumbar spinal stenosis (LSS)
时间窗: 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
时间窗: 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.
次要结局
- Change in Pain Scores in LSS Patients With and Without DP(Baseline, Visit 3 (variable by participant; up to Day 365))
- Change in PROMIS - Physical Function Score in LSS Patients With and Without DP(Baseline, Visit 3 (variable by participant; up to Day 365))
- 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, 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))
- Change in PROMIS - Physical Function Score in LSS Patients With and Without DP(Baseline, 6 Months Post-Visit 3 (variable by participant; up to Day 365 + 6 Months))