A Randomized Controlled Trial to Assess the Effects of Autologous Platelet Rich Plasma, Platelet Lysate, and Platelet Poor Plasma on Atrophied Multifidus Muscles in Patients With Axial Lower Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Post-treatment MRI
研究概览
简要总结
To evaluate and compare the effectiveness of 3 different injection treatments on multifidus atrophy and lower back pain.
详细描述
This study is a prospective, randomized controlled study of patients with atrophied multifidus muscles and axial lower back pain that are randomized to one of 3 treatment groups. Group 1 receives a series of 6 injections (1 time per week for 6 weeks) of platelet poor plasma into multifidus. Group 2 receives a series of 6 injections (1 time per week for 6 weeks) of platelet rich plasma (PRP) into multifidus. Group 3 receives a series of 3 injections (1 time every 2 weeks for 6 weeks) of PRP to multifidus, as well as PRP into facet joint, as well as an epidural injection of platelet lysate (PL).
Prior to procedure patient will undergo evaluation of medical history, back pain history, lumbar examination, medication use and review MRI of lumbar spine.
While lying prone, the patient's back will be exposed and prepped sterilely. While maintaining sterile technique, the physician will utilize US, x-ray or a combination of the two to guide the needles bilaterally into the multifidus, specifically the area of treatment using ultrasound, x-ray or a combination of the two. Once the lamina is reached the physician will either inject autologous 2.5 cc PPP (group 1) or will inject autologous 2.5 cc of 5x PRP into the multifidus muscle on one side and then repeat this on the opposite side for each level (group 2 & 3).
Additionally, for patients in group 3, using sterile technique under fluoroscopic guidance, the physician will guide a needle into the supraneural transforaminal space to perform an epidural injection with 2cc of 3x PL and 1 cc of 0.5% ropivacaine. Next, a needle will then be guided into the facet joint to perform an intra-articular injection with 1cc of 14x PRP. After the procedure, the patient will be cleaned and bandaged. The patient will be given standard rehab protocols to perform at home.
Patients will have follow-up visits with patient reported outcomes or pain and function at 3 months, 6 months and 12 months. A post-treatment MRI at 6 months will be compared to baseline MRI to measure changes to multifidus atrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signature of the Informed Consent
- •Axial low back pain for a minimum of 3 months
- •Male or female ages 18-75
- •Recent MRI (within last 6 months) consistent Kader grade 2 or 3 multifidus atrophy at 1 or 2 levels
- •Is independent, ambulatory, and can comply with all post-operative evaluations and visits
排除标准
- •Mild multifidus atrophy Kader grade 1
- •Multifidus atrophy at more than 2 levels
- •Symptomatic spinal stenosis (e.g. pseudoclaudication with moderate or severe MRI findings of stenosis)
- •Radicular symptoms (e.g. lower extremity radiating numbness, tingling, paresthesia, etc)
- •Fracture, previous spine surgery, neuromuscular disease of the trunk, malignancy, infection, or pregnancy
- •Radiofrequency ablation within the previous 12 months
- •Corticosteroid injection (epidural or facet) within the past 3 months
- •Contraindications for MRI
- •Condition represents a worker's compensation case
- •Currently involved in a health-related litigation procedure
- •Bleeding disorders
- •Allergy or intolerance to study medication
- •Use of chronic opioid
- •Documented history of drug abuse within six months of treatment
- •Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
结局指标
主要结局
Post-treatment MRI
时间窗: 6 months
Change in multifidus atrophy from baseline MRI
次要结局
- Single Assessment Numeric Evaluation Improvement Rating-modified(3 months, 6 months, 12 months)
- Functional Rating Index(3 months, 6 months, 12 months)
- Oswestry Low Back Disability Index(3 months, 6 months, 12 months)
- Numeric Pain Scale(3 months, 6 months, 12 months)