Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 20
- 主要终点
- Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)
研究概览
简要总结
The primary objective of this study is to document and compare diagnostic test results and procedure safety in subjects undergoing both Functional Anaesthetic DiscographyTM (F.A.D.) and provocative discography (PD) and determine the appropriateness of the F.A.D. procedure data collection script for use in a larger clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic axial low back pain without radicular pain for > six months, not responding to at least three months of non-surgical management under the direction of a physician.
- •One or two discs at L5/S1, L4/L5 or L3/L4 with abnormal findings by MRI, including any of the following: loss of disc hydration, loss of disc height, high intensity zone (HIZ), Modic changes at adjacent vertebral endplates, or herniation without nerve root compression.
- •Subject states that he/she is willing to undergo lumbar spinal fusion, disc replacement, or other definitive treatment if eventual diagnosis supports such treatment.
- •Physician believes that discography is clinically indicated for the purpose of surgical decision-making for the subject.
- •Pre-treatment low back pain by numerical rating scale (NRS) score > 4 (measured as average in last 24 hours on a 0-10 scale).
- •Pre-treatment Oswestry Disability Index (ODI) > 40 (0 - 100 scale).
- •Subject states availability for all study visits.
- •Subject is able to understand the risks and benefits of participating in the study and provides written informed consent.
排除标准
- •Known osteoporosis or osteopenia, metabolic bone disorder, or history of chronic steroid use (the equivalent of 7.5 milligrams of daily prednisone use for > 6 months).
- •Suspected painful disc degeneration (based on clinical examination and MRI findings) outside of L5/S1, L4/L5 or L3/L4 levels.
- •MRI shows disc abnormalities (listed in Inclusion Criteria #3) at all 3 lower lumbar discs (L3/L4, L4/L5 and L5/S1).
- •Abnormal neurologic exam attributable to lumbar disc disease, herniation, or lumbar stenosis.
- •Back, buttock or pelvic pain suspected to be due to spinal stenosis, spinal fractures, infection, cancer, facet arthropathy or other hip or pelvis pathology.
- •Schmorl's node or endplate disruption evident on MRI at L5/S1, L4/L5, or L3/L
- •Medical history, physical examination or radiographic evidence (e.g., disc height too narrow) to suggest that either PD or F.A.D. may not be technically feasible.
- •Any previous lumbar spine fusion or disc replacement.
- •More than grade 1 spondylolisthesis as assessed by x-ray or MRI.
- •Significant clinical comorbidity that may potentially interfere with data collection or follow-up (e.g., dementia, severe comorbid illness).
- •History of major depression, psychosis or somatization disorder, or panic disorder.
- •Allergy to any materials used in PD or F.A.D. devices, contrast, lidocaine, or bupivacaine.
- •Any evidence of disc or systemic infection.
- •Pregnant or child-bearing potential and not currently on adequate birth control method.
结局指标
主要结局
Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)
时间窗: Approximately 2 hours per subject
For provocative discography (PD), a positive response at an individual disc requires all of the following findings: pain intensity (\>=7/10 on 0-10 Numerical Rating Scale, NRS) as rated by subjects on injecting contrast into a disc; concordancy (pain reproduces typical back pain exactly). For Functional Anesthetic Discography (F.A.D.), a positive test at an individual disc level is defined as improvement in self-rated pain of \>=2 Numerical Rating Scale (NRS) points AND \>33% on 0-10 Numerical Rating Scale 10 minutes after injection of lidocaine.
次要结局
未报告次要终点