Study of Bone of Marrow Concentrate (BMC) Injection in Discs, Facets, Sacroiliac Joints, and Epidural Space for Chronic Lower Back Pain With and Without Radiculopathy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints
详细描述
To study if the outcomes for the injection of bone marrow concentrate (BMC) in patients with disc, facet, epidural space, and sacroiliac joint pain create a clinically meaningful improvement in pain and function. Further analysis will determine if there be any variance in patient reported outcome due to the individual's pre-procedure cell count and analysis.
Hypothesis 1: An injection of autologous BMC into discs, facets, sacroiliac joints, and epidural space will improve pain and function in patients with IDD
Hypothesis 2: There will be a direct relationship between an individual's BMC composition and the patient's reported outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent Observer was blinded as to wether a subject received treatment or was in the control group.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without protrusions/herniations and facet/sacroiliac joint pain
- •Patients with mild to severe spinal stenosis
- •Patients with radiculopathy
- •Patients with disc extrusions
- •Patients with failed spinal fusion
- •Patients with mild to severe facet arthropathy
- •Patients with suspected sacroiliac joint disease
- •Age 18 to 60 years
- •Mild to severe loss of intervertebral disc height
- •Pain is not responsive to conservative treatment measures (oral medication, epidural steroid injections, physical therapy)
- •Pain persists for an extended period of time (i.e., at least 3 months)
- •High intensity zone (HIZ) in annular fissure or adjacent to annular fissure detected on T2 or STIR MRI
- •No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
- •English speaking
排除标准
- •Spinal Deformity (Scoliosis >20 degrees, Spondylolisthesis)
- •Sequestered fragments, severe thecal sac compression
- •Severe neurologic deficit
- •Non-English speaking
- •Bone marrow disorders
- •Immunosuppressed Patients
- •Patients with coagulopathy
- •Localized infection in the area of skin penetration
- •Spinal infection
- •Serious medical co-morbidities
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: Two Years
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).
次要结局
- Numeric Rating Scale (NRS)(Two Years)
- Visual Analog Scale (VAS) for back pain(Two Years)
- Visual Analog Scale (VAS) for leg pain(Two Years)
- PROMIS Physical Health(Two Years)
- EURO Quality of Life (EuroQol)(Two Years)
- PROMIS Mental Health(Two Years)
- North American Spine Society (NASS) for patient satisfaction(Two Years)