The Role of Intra-articular Injection of Autologous Platelet Rich Plasma Versus Corticosteriods in Treatment of Synovitis in Lumbar Facet Joint Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Functional questionnaire score - Oswestry Disability Index ODI
研究概览
简要总结
Low back pain is an extremely common health problem and recent studies have shown that nearly up to 52% of patients have low back pain caused by lumbar facet joint syndrome. Intra-articular injection of facet joints has gradually become one of the vital therapeutic methods for lumbar facet joint syndrome, Steroid is one of the most commonly used injected drugs; however, previous studies have indicated that it has limited ability in long-term relief of low back pain. Therefore, it seems meaningful to apply a new injectable drug and to prove its effectiveness and safety for the treatment of lumbar facet joint syndrome. Recent studies indicate that autologous platelet rich plasma(PRP) is an appropriate injectable material with great potential in treating many different musculoskeletal disorders and currently it is not yet used on a wide scale as a treatment for lumbar facet joint synovitis. In this study the investigators compare the efficacy and safety of Intra-articular injection of PRP versus conventional steriods in patients with lumbar facet joint synovitis.
详细描述
The study is conducted upon Thirty patients who present to Ain Shams University hospitals outpatient clinic complaining of chronic low back pain diagnosed to have potential lumbar facet joint syndrome.
Intervention
After taking informed written consent the recruited patients will be subjected to the following:
- History:
I. Clinical Examination:
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Continuous or intermittent gradually progressive back pain for more than 3 months not significantly improving on medical treatment and/or physical modalities.
- •Patients age between 20 and 40 years.
- •Local / paraspinal pain or tenderness with or without radiation to buttock , groin or thigh.
- •Increase of pain on extension , rotation or lateral bending .
- •MRI detected synovitis of the facet joint as defined and graded by Czervionke and Fenton, 2008.
排除标准
- •• Acute low back trauma, fractures, malignancies and inflammatory diseases.
- •Pain score of < 4 at rest on visual analog scale.
- •Radicular neurologic complaints.
- •X-ray findings of long standing facet joint disease as; marked joint space narrowing, subchondral sclerosis or bone deformity/ sponylolithesis.
- •Evident disc herniation by MRI.
- •Prior surgery on the spine.
- •Prior interventional treatment on lumbar facet joints
- •Known hypersenstivity to local anesthesia, corticosteroid, contrast medium or blood derivatives.
- •Local or systemic infection or spinal infection.
- •Uncorrectable coagulopathy
- •Diabetes Mellitus
- •Pregnancy
研究组 & 干预措施
Group (I) Platelet Rich Plasma
The participants are randomly assigned for intra-articular injection with autologous platelet rich plasma . The treated segments are determined by clinical signs and MRI detected facet joint synovitis .
干预措施: Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma (Drug)
Group (II) Corticosteroids
The participants are randomly assigned for intra-articular injection with corticosteroids(a mixture of 0.5% lidocaine and 5mg/ml of betamethasone) . The treated segments will be determined by clinical signs and MRI detected facet joint synovitis .
干预措施: Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone (Drug)
结局指标
主要结局
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Functional questionnaire score - Oswestry Disability Index ODI
时间窗: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Oswestry Disability Index score (ODI) documented just before the intervention and at 3 month after the intervention, where score of 0% denotes fully functional participants and score of 100% denotes maximum functional affection and decrease of the score by 10% denotes significant improvement
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing number of lumbar facet joints showing synovitis on MRI and/or improving the grade of severity of the synovitis
时间窗: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of number of lumbar facet joints showing synovitis on MRI and/or improving (decrease in) the grade of severity of the synovitis graded from 0 to 4 according to the extent of lumber facet joint synovitis on MRI documented just before the intervention and at 3 month after the intervention
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing total number of lumbar facet joints showing tenderness on palpation on clinical examination
时间窗: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of total Number of lumbar facet joints showing tenderness on palpation in each participant documented just before the intervention and at 3 month after the intervention
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing maximum active lumber extension angle measured by goniometer
时间窗: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Maximum active lumber extension measured by goniometer in each participants documented just before the intervention and at 3 month after the intervention
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing the Visual analogue score (VAS)
时间窗: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Visual analogue score documented just before the intervention and at 3 month after the intervention where score of 0 denotes absence of pain and score of 10 denotes maximum pain and decrease in the sore denotes improvement as regards low back pain reported by the participants
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Roland Morris Disability questionnaire score (RMQ)
时间窗: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Roland Morris Disability questionnaire score (RMQ) documented just before the intervention and at 3 month after the intervention, where score 0 denotes absence of any disability and score of 24 denotes maximum disability of the participants and decrease in the score documented denotes improvement
次要结局
未报告次要终点
研究者
Shahdan Yousry Abdelmonem Kotb
Assistant Lecturer of Physical medicine and Rehabilitation
Ain Shams University