Effectiveness of ultrasound guided intraarticular injection of platelet rich plasma compared with triamcinolone hexacetonide in improvement of pain and function in patients with adhesive capsulitis: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Function in terms of Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
This study is a randomized, parallel group, active control trial comparing the effectiveness of ultrasound guided intra articular injection of 4ml Platelet rich plasma with 1 ml triamcinolone hexacetonide 20mg/ml in improvement of pain and function in 64 patients with adhesive capsulitis of shoulder. This study will be conducted in Department of Physical Medicine and Rehabilitation , Regional Institute of Medical Sciences, Imphal, Manipur in India. The primary outcome measures will be improvement in pain and function as measured by SPADI and secondary outcome measures will be pain measured by VAS and shoulder function measured by Range of motion which all will be asses at 1week, 4weeks, 12 weeks and 24 weeks post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed case of adhesive capsulitis, Patients who are willing to comply with the study and follow up assessments.
排除标准
- •Patients with uncontrolled diabetes History of shoulder trauma/surgery History of injection in the shoulder joint in past three months Non-steroidal anti-inflammatory drugs intake in last seven days Coagulopathy Thrombocytopenia (1.5 lakh/microlitre) Autoimmune disorders Impaired cognition Any febrile or infectious disease (systemic & local).
结局指标
主要结局
Shoulder Pain and Function in terms of Shoulder Pain and Disability Index (SPADI)
时间窗: 1 week, 4 week, 12 week, 24 week
次要结局
- Pain in terms of Visual Analogue Scale (VAS)(1 week, 4 weeks, 12 weeks, 24 weeks)
- Shoulder function in terms of Range of Motion(1 week, 4 weeks, 12 weeks, 24 weeks)