Effectiveness of ultrasound guided intra-articular injections of ozone and hyaluronic acid in improving pain and physical function in patients with primary osteoarthritis of knee: A randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Pain by VAS score
研究概览
简要总结
Osteoarthritis of knee is a chronic degenerative disease with loss of joint surface cartilage leading to pain, stiffness and joint deformity affecting one’s day to day activities. The aim of my study is to compare the effectiveness of ultrasound guided intra-articular injections of ozone and hyaluronic acid in improving pain and physical function in patients with primary osteoarthritis of knee. The VAS and WOMAC will be measured before treatment and at the end of 1 month, 3 months and 6 months post intervention. Data will be analyzed using SPSS 25 version. For descriptive statistics, mean, standard deviation and percentage will be used. For comparing categorical data, Chi-square test will be used. Independent t-test will be used for comparison between the groups and mean changes from baseline within each group will be compared by repeated measures ANOVA test. A p-value < 0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group 40 to 65 years Patients with primary osteoarthritis of knee fulfilling 2016 ACR (American college of Rheumatology) revised criteria for early diagnosis of knee OA Osteoarthritis of knee with Kellgren-Lawrence grade 1,2 and 3 Willingness to participate in the study and comply with treatment and follow up VAS more than 4.
排除标准
- •Recent knee trauma or knee surgery Knee infection Cognitive impairment Intra-articular injection of steroid/PRP/hyaluronic acid during past 3 months BMI more than 30 Bleeding disorders Recent myocardial infarction or stroke Uncontrolled systemic diseases.
结局指标
主要结局
Pain by VAS score
时间窗: Baseline, 1 month, 3 months and 6 months
次要结局
- Physical function by WOMAC score(Baseline, 1 month, 3 months,)
研究者
Yambem Hellena Devi
Regional Institute of Medical Sciences, Imphal, Manipur