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临床试验/CTRI/2023/10/058975
CTRI/2023/10/058975尚未招募2 期

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

Shruti Pandey1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年10月20日最近更新:

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)

研究者

发起方
Shruti Pandey
申办方类型
Other [self]

研究点 (1)

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