Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1-Visual analogue scale. ,
研究概览
简要总结
Spondylolisthesis is a serious health condition that is often treated with surgery or pain-relieving lumbar epidural steroids. Patients with persistent and debilitating symptoms who have failed to respond to conservative treatment should consider surgery.
Objectives: The aim of this study was to compare the therapeutic efficacy of three ultrasound guided PRP injections of the facet joint capsule to surgical procedures in patients with degenerative spondylolisthesis G1 and their effect on neurogenic pain relief and functional improvement over a one-year follow-up period.
Methods:
A one-year prospective randomised comparative clinical trial was performed on 60 patients with degenerative spondylolisthesis G1 who were randomly assigned to one of two groups: Group 1: thirty patients were injected in the facet joint capsule with a series of three ultrasound-guided PRP injections at four-week intervals, and Group 2: thirty patients underwent surgery. They were exposed to clinical neuropsychological testing.They were assessed for pain and function using clinical neurological assessments, VAS (Visual Analogue Scale), FRI (Functional Rating Index), Roland Morris, and ODI.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with degenerative spondylolithesis Grade 1 were diagnosed based on their clinical and radiological image.
- •Patients complained of extreme pain and received medical treatment (NSAIDS) without improvement.
排除标准
- •Patients with more than two-level pathological lesions and those who had previously
- •Patients undergone lumbar surgery,
- •HCV, HBV infected patients,
- •patients with local abscesses,
- •diabetes mellitus,
- •malignancy, pregnancy,
- •blood disorders (coagulopathy, thrombocytopenia),
- •patients who had previously received local injection of steroid within past 3 weeks
- •Patients who had undergone lumbar surgery,
- •patients with advanced spondylolithesis, disc prolapse,
- •inflammatory or musculoskeletal disorders of the spine.
结局指标
主要结局
1-Visual analogue scale. ,
时间窗: 12 months
VAS Visual analogue scale: According to the VAS, the pain severity was calculated by the patients on a scale of 0 (no pain) to 10 (agonising pain)
2-The Persian Functional Rating Index (FRI )
时间窗: 12 months
The Persian Functional Rating Index (FRI ), which is an accurate and valid instrument that contains 10 items that measure both pain and function, with an impairment score ranging from 0% (no disability) to 100% (severe disability) 2- The Persian Functional Rating Index (FRI ), which is an accurate and valid instrument that contains 10 items that measure both pain and function, with an impairment score ranging from 0% (no disability) to 100% (severe disability)
次要结局
- Oswestry Disability Index (ODI) for low back pain(12 months)
- The Roland-Morris questionnaire(12 months)
研究者
Dalia Salah Saif
lecturer of Rheumatology at faculty of medicine Menoufia University
Menoufia University