Comparison of Ultrasound Guided Genicular Nerve Block using 0.5% bupivacaine inCombination with Intra-Articular Platelet Rich Plasma Protein and Intra-Articular Steroids amongPatients with Chronic Knee Osteoarthritis – A Triple Blinded Randomized Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Pain using Visual Analog Scale (VAS)
研究概览
简要总结
Summary
Osteoarthritis is a progressive, degenerative process that affects joint cartilage and the subchondral bone. There are many different conservative treatments or minimally invasive treatments offered for patients with knee osteoarthritis. Several studies have reported the successful performance of GNB under ultrasound guidance. Literature suggests that GNB, when administered together with a corticosteroid, is as effective as RF genicular ablation. It is already known that Platelet-rich plasma protein (PRP) contains cytokines and growth factors that are capable of stimulating cellular growth, vascularization, proliferation, tissue regeneration, and collagen synthesis. However, there is paucity in literature with regard to the efficacy of genicular nerve block when administered with PRP on pain reduction. Hence the study was planned to compare the effectiveness of Ultrasound-Guided Genicular Nerve Block using 0.5% bupivacaine in Combination with Intra-Articular Platelet Rich Plasma Protein and Intra-Articular Steroids among Patients with Chronic Knee Osteoarthritis
Population: Patients with chronic knee pain
Intervention: Administration of 0.5% bupivacaine plus PRP during ultrasound-guided genicular nerve block.
Comparison: Administration of 0.5% bupivacaine with steroids during ultrasound-guided genicular nerve block.
Outcome:
a) Primary outcome is to assess the mean changes from baseline levels of knee pain to 1, 2, 4, and 8 weeks after GNB, as measured using Visual Analog Scale (VAS)
b) Secondary outcomes are the assessment of functional changes in the knee, patient satisfaction with treatment, and the incidence of adverse effects.
Time: Patients will be followed up at different time intervals i.e., 1, 2, 4 and 8 weeks after Genicular Nerve Block
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged 50–80 years with knee pain of moderate or greater intensity on most or all days for ≥ 3 months and radiological tibiofemoral OA (Kellgren-Lawrence grade 2–4 as evaluated by a radiologist).
排除标准
- •Subjects with acute knee pain
- •Subjects who underwent prior knee surgery or electropuncture treatment
- •Subjects with other connective tissue diseases that affected the knee, serious neurological or psychiatric disorders
- •Subjects under steroid or hyaluronic acid injection therapy during the previous 3 months
- •Subjects with sciatic pain, anticoagulant medication use and pacemaker use.
结局指标
主要结局
Pain using Visual Analog Scale (VAS)
时间窗: 1, 2, 4, and 8 weeks
次要结局
- Functional changes in the knee using Oxford Knee Scores (OKS)(Patient satisfaction with treatment using Global Perceived Effects and)