Thoraco-Lumbar Fascia Mobility in Persons With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Examine changes in thoracolumbar fascia movement (called shear-strain) using ultrasound
研究概览
简要总结
The purpose of the Thoraco-Lumbar Fascial Mobility (TLFM) study is to use ultrasound to measure the movement of connective tissue in the low back area of individuals with chronic low back pain (lasting more than 1 year). This study will compare baseline measurements, measurements after a single high velocity low amplitude spinal manipulation (HVLA-SM) and after a course of up to 16 HVLA-SM.
详细描述
The investigators will conduct a single arm pilot (proof-of-concept) clinical trial. Approximately 30 participants with self-reported chronic low-back pain (LBP), defined as pain for ≥ 1-year in duration and pain on at least ½ of the days in the past 6-months, will be enrolled.
This trial will consist of two separate enrollment phases. Phase 1 consists of enrollment at baseline followed by 3 separate ultrasound measurements. Phase 1 ends after a 4-week no treatment run-in phase.
Phase 2 begins twice-weekly HVLA-SM treatments to the thoracolumbar region for 8-weeks. Two ultrasound imaging evaluations will occur at visit 1 (pre and post-treatment). Pre-treatment ultrasound evaluations will be obtained at 4-weeks and 8-weeks.
The primary outcome is shear strain (adjacent tissue layer mobility measured with ultrasound) at the level of the lumbar L2-L3 vertebrae bilaterally. Ultrasound measures will be obtained with a Terason t3000 system using a 12L5 linear array probe with 10 MHz setting. Because shear strain may differ between sexes, we will attempt to recruit equal numbers of male and female participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Data analysis will be performed by blinded personnel. As a single group trial involving a manual therapy, participant and provider blinding is not feasible.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Chiropractic care or other manual therapy for at least 90 days prior to baseline visit
- •Unable to visualize necessary tissue layers using musculoskeletal ultrasound
- •Weight above 350 lbs
- •Unable to tolerate or safely receive study procedures
- •Need for referral
- •Unable or unwilling to comply with study procedures
- •Current or planned pregnancy (self-reported) within the study timeframe
- •Any prior surgery to the thoracolumbar region
- •Needing a proxy
- •Connective tissue disorder such as Marfan and Ehlers-Danlos syndrome
结局指标
主要结局
Examine changes in thoracolumbar fascia movement (called shear-strain) using ultrasound
时间窗: Short term change (Baseline), longer-term change (4 weeks)
Short and longer-term changes in shear-strain will be studied by comparing between ultrasound recordings obtained at baseline and between measurements obtained at baseline and after 4-weeks
Investigate changes in thoracolumbar fascia movement (called shear-strain) using ultrasound after high-velocity low-amplitude spinal manipulation
时间窗: 4-weeks, 8-weeks, 12 weeks
Changes in shear-strain measures associated with high-velocity low-amplitude spinal manipulation will be assessed at 3 separate time points.
Examine differences in thoracolumbar movement (called shear-strain) using ultrasound. Measurements will be obtained in relaxed and active muscle contraction states
时间窗: Baseline
Compare thoracolumbar shear strain during relaxed passive flexion with active paraspinal contraction during passive flexion.
次要结局
- Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions on pain intensity(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions of pain interference(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Roland Morris Disability Questionnaire (RMDQ)(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Patient Reported Outcomes Measurement Information System (PROMIS) nociceptive pain quality scale(Baseline)
- Perceived Global Low Back Pain Improvement(12 weeks)
- Patient Reported Outcomes Measurement Information System (PROMIS) neuropathic pain quality scale(Baseline)