A Randomized, Double-blind Controlled Trial of the Efficacy of an Intra-discal Injection of Autologous Platelet-rich Plasma (PRP) Enriched With Exosomes (PRPex) Versus Placebo in Chronic Low Back Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- SF 36 health questionnaire
研究概览
简要总结
Intervertebral disc pathology accounts for 40% or more cases of chronic LBP. Available treatment options do not improve the underlying degenerative condition hence This indicates the need for new therapies.
intradiscal injection of PRP with exosomes derived from blood may potentially transmit some of the unique stem cell properties to other stem cells, facilitating stemness maintenance, differentiation, self-renewal, and repair.
controlled, randomized, double-blind placebo clinical trial to compare the safety and efficacy of PRP with exosomes in discogenic LBP adminstartion of PRP with exosomes at the centre of the nucleus pulposus or equal amount of placebo paradiscal patients wil be elvaluated for primary Outcome measures viz: Visual analog scale (VAS), Roland Morris Disability Questionnaire (RDQ), SF 36 health questionnaire, Functional rating index and Secondary: MRI - disc degeneration grading, T2 quantification, and for any Adverse events including of discitis
详细描述
Management of chronic low back pain (LBP) has contributed to its high socioeconomic The intervertebral disc accounts for 40% or more cases of chronic LBP. Available treatment options do not improve the underlying degenerative condition, although they do resolve its symptoms. This indicates the need for new therapies and/or interventions that actually treat the underlying causes of discogenic pain. Biological therapies by direct injection of PRP into the annulus fibrosus and nucleus pulposus seems an effective and feasible option.
Exosomes derived from blood may potentially transmit some of the unique stem cell properties to other stem cells, facilitating stemness maintenance, differentiation, self-renewal, and repair.
We propose to have a controlled, randomized, double-blind clinical trial to compare the safety and efficacy of exosomes in LBP. Informed consent will be obtained from all subjects prior to study participation.
PRP Preparation:
Blood sample (60 ml) will be centrifuged at 600×g for 10 min to collect plasma fraction. And centrifuged at 4000×g for 15 min. Supernatant platelet poor plasma (PPP) will be then removed, leaving 1 ml PRP. PPP will be passed through one-micron special indigenous designed flush back filter (Alpha Corpuscle, Delhi, India) so that all the platelets present in PPP fraction will get trapped in the filter. These trapped platelets will be flushed back with 1 ml of PPP to retrieve most of the platelets. This will be mixed together and then passed through a WBC filter (Terumo Imuguard, USA) to filter off the leukocytes. The final PRP concentrate (0.1 ml) will be analysed for total leukocyte & platelet counts. Five samples will be selected randomly treated with bovine thrombin reconstituted in 10% calcium chloride will be assessed for growth factors [platelet-derived growth factors (PDGF) and vascular endothelial growth factors (VEGF)] by ELISA.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will be randomly selected based on computer generated number to receive one undistinguishable injection of PRP ex or placebo.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between18 Years to 60 Years of any sex
- •Written and signed informed consent form
- •Chronic low back pain without leg pain for more than 3 months.
- •Symptomatic moderate to severe discogenic low back pain as defined according to the following criteria: centralized chronic low back that increased with activity and lasted at least six months.
- •Failure of conservative treatment measures (oral medications, rehabilitation therapy, and/or injection therapy)
- •Evidence of degeneration, as indicated via magnetic resonance imaging (MRI) decreased signal intensity on T
- •MRI Pfirrmann (MRI) score 3-6
- •Modic Grade II change or less
- •Disk protrusion less than 5 mm on magnetic resonance imaging maintenance of 50% or more of normal disc height. An intact annulus is not required
- •Subjects must be able to attend all scheduled visits and to comply with all trial procedures
排除标准
- •Spinal stenosis
- •An abnormal neurologic exam
- •Symptomatic compressive pathology
- •A disc herniation causing significant compression with neurologic deficit.
- •Extrusions or sequestered disk fragments
- •Any spondylolisthesis or spondylolysis.
- •Presence of a grade 5 annular fissure on discography
研究组 & 干预措施
Placebo
Placebo (trigger point injection under C-arm)
干预措施: Normal Saline (Drug)
Platelet rich plasma (PRP) with exosomes
PRP with exosomes at the center of the nucleus pulposus (2ml)
干预措施: Platelet rich plasma (PRP) with exosomes (Biological)
结局指标
主要结局
SF 36 health questionnaire
时间窗: Change from Baseline SF 36 at 1,3,6,12 months
The SF.36 questionnaire (SF-36) contains 36 items that assess patients' health status and its impact on their lives. It comprises 36 questions which cover eight domains of health 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems 3. Limitations in usual role activities because of physical health problems 4. Bodily pain 5. General mental health (psychological distress and well-being) 6. Limitations in usual role activities because of emotional problems 7. Vitality (energy and fatigue) 8. General health perceptions. Change in SF 36 will be assessed.
Functional rating index
时间窗: Change from Baseline Functional rating index at 1,3,6,12 months
The Functional Rating Index (FRI) is an instrument specifically designed to quantitatively measure the subjective perception of function and pain of the spinal musculoskeletal system. Change will be assessed.
Visual analog scale (VAS)
时间窗: Change from Baseline VAS at 1,3, 6,12 months
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. Change in VAS score will be assessed.
Roland Morris Disability Questionnaire (RDQ)
时间窗: Change from Baseline RDQ at 1,3,6,12 months
The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)
次要结局
- MRI(Changes from baseline MRI findings will be assesed at 12 months)
研究者
anupama agrawal
Principal Investigator
Dr. Himanshu Bansal Foundation