Clinical Outcome After Lumbar Fusion for the Treatment of Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Change from Baseline Visual Analog Scale (VAS)
研究概览
简要总结
The main objective of this prospective study is to compare the clinical outcomes after lumbar fusion for chronic low back pain using the four techniques commonly employed in our surgical practice. Lumbar fusion stops motion at a painful vertebral segment, which can decrease back pain. The four techniques are standard transforaminal lumbar interbody fusion (S TLIF), minimally invasive transforaminal lumbar interbody fusion (MI TLIF), extreme lateral interbody fusion (XLIF), and axial lumbar interbody fusion (AxiaLIF). Each differ in where incisions are made and level of invasiveness; not all may be implemented in each surgical case. The four different techniques are all standard approaches with different advantages and have yet to be compared in efficacy for relieving chronic low back pain.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe chronic low back pain (at least 7 out of 10 on the VAS scale).
- •Age: 25-65 years.
- •Pain duration at least 2 years.
- •The treating surgeon should interpret the pain as emanating from L4-S
- •The patient must have had unsuccessful maximal possible conservative (non surgical) treatment for at least one year.
- •Radiographic evidence (MRI, CT, CT-SPECT, and/or plain films) of degenerative changes ("spondylosis")
排除标准
- •Psychiatric illness or evidence of emotional instability.
- •Previous spine surgery except for successful removal of a herniated disc more than 2 years before entering the study and with no persistent nerve root symptoms.
- •Specific radiologic findings, such as fractures, infection, inflammatory process, or neoplasm.
- •Obvious painful and disabling arthritic hip joints and anamnestic and radiologic signs of spinal stenosis.
- •Involvement in Workman's Comp or litigation.
结局指标
主要结局
Change from Baseline Visual Analog Scale (VAS)
时间窗: 2 weeks, 6 months, 1 year
This is part of the Patient Questionnaire primary outcome measure. A Visual Analogue Scale (VAS) is a measurement instrument that measures the intensity or frequency of pain across a continuum of values.
Change from Baseline Prolo Functional and Economic Score
时间窗: 2 weeks, 6 months, 1 year
This is part of the Patient Questionnaire primary outcome measure. The Prolo Score is a 10-point scale consisting of only two questions evaluating the functional and economic status of the patient.
Change from Baseline Dallas Pain Questionnaire (DPQ)
时间窗: 2 weeks, 6 months, 1 year
This is part of the Patient Questionnaire primary outcome measure. The Dallas Pain Questionnaire (DPQ) assess the amount of chronic spine pain that affects the patient's daily and work-leisure activities, anxiety-depression, and social interest.
Change from Baseline Short Form 12 (SF-12)
时间窗: 2 weeks, 6 months, 1 year
This is part of the Patient Questionnaire primary outcome measure. The Short Form 12 (SF-12) was designed to measure the patient's functional health and well-being.
Change from Baseline Oswestry Disability Index (ODI)
时间窗: 2 weeks, 6 months, 1 year
This is part of the Patient Questionnaire primary outcome measure. The Oswestry Disability Index measures a patient's impairment and quality of life due to pain.
次要结局
- Radiologic Fusion Rates(6 months and 1 year)
研究者
Gabriel C. Tender, MD
Clinical Professor
Louisiana State University Health Sciences Center in New Orleans