A Trial of Platelet Injections for Treatment of Painful Degenerative Disc Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Numeric Pain Scale (NPS)
研究概览
简要总结
To evaluate and compare two platelet-based treatments of the functional spinal unit spaced 4 weeks apart to sham procedures for the treatment of degenerative disc disease.
详细描述
This is a single-blind, randomized, placebo-controlled study using platelet-based treatment to the functional spinal unit .in a series of 2 treatments 4 weeks apart to treat painful lumbar degenerative disc disease. Randomization is 2:1, with 28 in the treatment group and 14 in the sham control group.
A pretreatment visit will occur at or before the time of enrollment; follow-up visits will occur at the clinical site at 3- and 12 months post injection. Target enrollment is 42 subjects. Patients in the control group can crossover to the treatment group after 3-month follow-up. Crossover patients then follow the treatment group follow-up timeline based on their second real treatment. Subjects will complete the study following the 1-year follow-up visit.
The primary objective of this study is to observe the improvement in subject-reported clinical outcomes from baseline to 3 months after 2nd treatment and between groups at 3 months, with continued evaluation of efficacy and durability up to 12 months. Questionnaires are completed at 1, 3, 6, and 12 months.
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)
盲法说明
Single-blind
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
- •Voluntary signature of the IRB approved Informed Consent,
- •Skeletally mature Male or Female ages 25 to 65
- •Maximum of 3 levels degenerative disc disease without significant spondylolisthesis in the area c/w the pain (grade 1 with less than or equal to 10% vertebral body)
- •Chronic back and/or leg pain having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 6 months
- •MRI and physical examination consistent with painful Degenerative Disc Disease
- •Failure of epidural steroid injection, facet injection, medial branch block, radiofrequency ablation or physical therapy
- •Instability as seen on MRI, flexion-extension x-ray, or physical deformity as seen on MRI c/w degenerative instability (facet hypertrophy, loss of disc height, spondylolisthesis, laterolisthesis, osteophytes)
- •A lumbar surgery candidate (will need to specify which surgery, ie. fusion, decompression, etc)
- •Is independent, ambulatory, and can comply with all post-operative evaluations and visits
- •Exclusion criteria:
- •Evidence of more than moderate central canal or foraminal stenosis
- •Smoker or cessation for less than 6 weeks
- •Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor to chronic pain
- •Prior epidural steroid injection within the past 8 weeks
- •Degenerative scoliosis if cob angle over 10 degrees
- •Undergone previous Regenexx lumbar procedure
- •Standing intolerance (patient cannot stand longer than 30 minutes)
- •Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
- •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
- •Central sensitization
- •Hypermobile or EDS
- •Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
排除标准
- 未提供
研究组 & 干预措施
Platelet treatment
A series of two treatments spaced 4 weeks apart that include platelet-rich plasma (PRP). platelet lysate (PL), and platelet poor plasma (PPP).
干预措施: Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP) (Biological)
Sham procedure
A series of two sham procedures spaced 4 weeks apart.
干预措施: Sham procedure (Other)
结局指标
主要结局
Numeric Pain Scale (NPS)
时间窗: 3-months after 2nd treatment
Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain
Modified Single Assessment Numerical Evaluation (SANE) scores
时间窗: 3-months after 2nd treatment
Difference in modified Single Assessment Numerical Evaluation score group differences; scores range from 0-100 where 0=no improvement and 100=100% improved
次要结局
- Numeric Pain Scale (NPS)(Baseline, 1-month, 3-months, 6 months, 12 months)
- Functional Rating Index (FRI)(Baseline, 1-month, 3-months, 6 months, 12 months)
- Incidence rate of adverse events(1 month, 3 months, 6 months and 12 months)
- Mean modified SANE scores(1-month, 3-months, 6 months, 12 months)
- Oswestry Disability Index (ODI)(Baseline, 1-month, 3-months, 6 months, 12 months)
- Incidence rate of surgical/other treatment interventions(1 month, 3 months , 6 months and 12 months)
- Pain medications(1 month, 3 months, 6 months and 12 months)