Comparison of ultrasound guided intra-articular injection of platelet rich plasma and triamcinolone acetonide in the reduction of pain and functional improvement in primary temporomandibular joint osteoarthritis: 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
- 38
- 试验地点
- 1
- 主要终点
- 1. pain through VAS
研究概览
简要总结
temporomandibular joint osteoarthritis (TMJ OA) affects 5-12% of world population and is more prevalent in india with 22-29% occurrence and without intervention it negatively affects quality of life. primary TMJ OA is characterized by absence of distinct local or systemic factors. there are many trreatment options like occlusal splint, NSAIDs, I/A steroid injection, hyalouronic injection, but with recent advancement and studies coming up with platelet rich plasma (PRP) showing it’s anti- inflammatory and regenerative properties makes it novel treatment option for management of pain and function among patients suffering with TMJ OA . This study will be conducted to compare the efficacy of I/A injection under ultrasound guidance of steroid (triamcinolone acetonide) with PRP in reduction of pain and functional improvement in primary cases of TMJ OA . Study will be a randomized controlled trial conducted in Regional Institute of Medical Science, Imphal.
outcome measures will be measured at baseline at 1, 4, 12 and 24 weeks respectively. Data will be analyzed using IBM-SPSS 25 version, for descritive data chi square will be used and for comparative data student t test, paired t test and ANOVA will be used and p value of <0.05 will be taken as significant
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •symptomatic primary temporomandibular joint osteoarthritis (TMJ OA) unilateral TMJ OA CT confirmed cases of TMJ OA patients willing to be part of study and follow up.
排除标准
- •patients with previous trauma or dental intervention H/O inflammatory arthritis uncontrolled systemic illness bleeding disorder allergic to local anaesthetics thrombocytopenia.
结局指标
主要结局
1. pain through VAS
时间窗: 1. 1 week | 2. 4 week | 3. 12 week | 4. 24 week | Pain expected to improve at 1 week with prolong effect till 24 week of follow up
次要结局
- Pain and function of temporomandibular joint assessed through VAS and MFIQ(1. 1 week)
