The Efficacy and Safety of Platelet Rich Plasma Spinoplasty in the Management of Lower Back Pain Due to Multiple Pathologies: A Quasi-Experimental Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Quantifying pain intensity using Numeric Pain Scale (NPS)
研究概览
简要总结
This study aimed to evaluate the efficacy and safety of a comprehensive, multi-target injection protocol, termed 'PRP Spinoplasty,' for managing chronic LBP stemming from concurrent lumbar disc and facet joint disease with associated muscle spasms.
详细描述
A quasi-experimental study was conducted on 29 patients with chronic LBP who failed conservative therapy. The PRP Spinoplasty protocol involved a single-session, fluoroscopy-guided administration of autologous PRP to the interlaminar epidural space, affected facet joints, and paraspinal muscle trigger points. Outcomes were assessed using the Numeric Pain Scale (NPS), Oswestry Disability Index (ODI), and Single Assessment Numeric Evaluation (SANE) at baseline and at 1 week, 1 month, 3 months, and 6 months post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes; ages between 18 and 80 years.
- •Lower back pain consistent with lumbosacral radiculopathy, facet arthropathy, and muscle spasms.
- •MRI-confirmed lumbar spine pathology (disc disease and/or facet arthropathy).
- •Failure to respond to at least 3 months of conservative therapy (NSAIDS and physical therapy).
- •Pain score ≥ 6; on the 10-point Numeric Pain Scale (NPS) at baseline.
排除标准
- •Presence of local or systemic infection, or fever.
- •Diagnosed with cancer within the past 12 months.
- •Unable to give a consent.
- •History of spinal deformity such as fracture, or severe spinal stenosis causing neurological deficit.
- •Presence of lower extremity weakness or urinary tract symptoms related to spinal pathology.
- •Previous spinal decompression or fusion surgery at the treatment level.
- •Receipt of any spine injection within the previous 12 months.
- •Use of NSAIDs within 2 weeks prior to, or 6 weeks following the procedure.
- •Use of corticosteroids within 6 weeks prior, or after the procedure.
- •Use of anticoagulation or antiplatelet drugs (excluding low-dose Aspirin).
- •History of blood disorders.
- •History of any major surgery within the past 3 months.
研究组 & 干预措施
Adult patients with chronic low back pain secondary to lumbar disc disease and facet arthropathy
The study population consisted of 35 adult patients with a diagnosis of chronic low back pain secondary to lumbar disc disease and facet arthropathy, with an associated component of muscular spasm. Diagnoses were confirmed by an interventional pain specialist based on a detailed medical history, physical examination, and magnetic resonance imaging (MRI) findings.
干预措施: Spinoplasty with Platelet Rich Plasma (Biological)
结局指标
主要结局
Quantifying pain intensity using Numeric Pain Scale (NPS)
时间窗: 0-6 months
An 11-point scale (0 = no pain, 10 = worst imaginable pain) used to quantify pain intensity
Assessing level of functional disability using Oswestry Disability Index (ODI)
时间窗: 0-6 months
A 10-item questionnaire assessing the level of functional disability due to low back pain. Scores are calculated from a raw point score of 0-52, with lower scores indicating less disability. The raw score corresponds to the following disability levels: 0-4 points (No disability), 5-14 points (Mild disability), 15-24 points (Moderate disability), 25-34 points (Severe disability), and 35-52 points (Completely disabled)
Assessing patient's condition using Single Assessment Numeric Evaluation (SANE)
时间窗: 0-6 months
A patient-reported global assessment score where patients rate their condition on a scale of 0-100%, comparing their current status to their pre-injury baseline
次要结局
- Assessing adverse events from treatment(0-6 months)
研究者
Dr. Mustafa A Hammad
Medical Director and Principal Investigator
Allmed Medical Center