Oral Steroid Dose Pack Used As A Predictor For The Effectiveness Of Epidural Steroid Injections
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Patient-Reported Pain
研究概览
简要总结
The purpose of this observational study is to show whether a standard oral steroid dose pack can be used as a screening tool to assess the effectiveness of a subsequent epidural steroid injection (ESI). If an oral steroid does not give a patient significant temporary relief of pain from a herniated lumbar disc then an epidural steroid injection will not either. Therefore the risk and expense associated from the interventional pain management procedure for those patients could be avoided and other treatment modalities pursued.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Diagnosed by participating physicians during the study enrollment period as having intervertebral disk herniation and persistent symptoms with or without some nonoperative treatment for at least 4 weeks
- •Radicular pain (below the knee for lower lumbar herniations, into the anterior thigh for upper lumbar herniations)
- •Evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raise-positive between 30° and 70°) or a corresponding neurologic deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution)
- •Undergone either MRI or CT scan showing disc herniation (protrusion, extrusion, or sequestered fragment) at a level and side corresponding to the clinical symptoms
- •Patients with multiple herniations can be included if only one of the herniations is considered symptomatic
- •Preenrollment nonprocedural care can include: education/counseling, physical therapy, chiropractic therapy, anti-inflammatory medications, opioid analgesics, adjuvant analgesics such as anticonvulsants and antidepressants
排除标准
- •Prior lumbar surgery
- •Cauda equina syndrome
- •Vertebral fractures
- •Spine infection or tumor
- •Severe motor deficit
- •Inflammatory spondyloarthropathy
- •Pregnancy
- •Cardiac or pulmonary comorbid conditions contraindicating interventional procedures
- •Inability/unwillingness to have spinal injections
结局指标
主要结局
Change in Patient-Reported Pain
时间窗: Baseline,1 wk post oral steroid completion, 2 wks post ESI #1, 2 wks post ESI #2, 2 wks post ESI #3, then at 6 wks, 12 wks, 6 mo. & 12 mo. after last transforaminal ESI (TRESI).
The primary endpoint will be a patient-reported pain as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being the most severe pain imaginable.
次要结局
未报告次要终点
研究者
Bert L. Fichman
Staff Physician
Dartmouth-Hitchcock Medical Center