A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index Change from Baseline
研究概览
简要总结
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and durability up to 12 months.
Secondary objectives include incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
详细描述
Prospective, single-blinded, randomized, controlled to include 25 subjects treated with Regenexx PL-Disc and 25 subjects treated with steroid epidural injection with the steroid epidural group crossing over to the PL-Disc injection group at 3 months.
Subjects will have symptoms consistent with lumbar radiculopathy confirmed by physical examination.
Subjects will be enrolled within 60 days prior to injection and take part in follow-up visits for one year following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months and 12 months post injection. Subjects will remain blinded to the treatment allocation through at least the 3 month primary endpoint. Control subjects not improving after the 3 month visit will be unblinded and given the opportunity to cross-over to the PL-Disc group.
Subjects will complete the study following the 1 year follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain, spasm, or functional disability in the low back and diagnosed as radiculopathy having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months and not longer than 2 years
- •Significant functional disability related to pain, lack of strength, or other back or leg symptoms
- •Physical examination consistent with lumbar radiculopathy
- •Lumbar disc bulge, herniation, and/or Kader grade 2 or greater multifidus atrophy evident on MRI and consistent with physical exam findings
- •Is independent, ambulatory, and can comply with all post-operative evaluations and visits
排除标准
- •Symptomatic central or foraminal stenosis
- •Previous low back surgery
- •Prior epidural steroid injection or other low back injection therapy within the past year
- •>50% loss of disc height at the symptomatic level
- •Spondylolisthesis
- •Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
- •Quinolone or Statin induced myopathy/tendinopathy
- •Severe neurogenic inflammation of the cutaneous nerves
- •Condition represents a worker's compensation case
- •Currently involved in a health-related litigation procedure
- •Is pregnant
- •Bleeding disorders
- •Currently taking anticoagulant or immunosuppressive medication
- •Allergy or intolerance to study medication
- •Use of chronic opioid,
- •Documented history of drug abuse within six months of treatment
结局指标
主要结局
Oswestry Disability Index Change from Baseline
时间窗: Change from baseline to 3 months
The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in Oswestry Disability Index (ODI) scores.
次要结局
- Mean ODI scores(6 weeks, 3 months, 6 months, 12 months)
- Mean Pain Scales(6 weeks, 3 months, 6 months, 12 months)
- Incidence of Complications and Adverse Events(12 months)
- Use of pain medications(6 weeks, 3 months, 6 months, 12 months)
- Time to Resolution of Complications and Adverse Events(12 months)
- Time to re-injection/re-operation(12 months)
- Mean Functional Rating Index Scores(6 weeks, 3 months, 6 months, 12 months)
- Incidence of re-injection/re-operation(12 months)