Effectiveness of ultrasound-guided platelet-rich plasma injection in comparison with conservative management in improving pain and function in athletes with Rockwood grade III acromioclavicular joint injuries of shoulder: a randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Shoulder pain measured by Visual Analogue Scale (VAS)
研究概览
简要总结
**Title:**
Effectiveness of ultrasound-guided platelet-rich plasma injection in comparison with conservative management in improving pain and function in athletes with Rockwood grade III acromioclavicular joint injuries of the shoulder: a randomized controlled trial.
**Investigator:**
Dr. Laimujam Sobhasini Devi
**Supervisor/Guide:**
Dr. Akoijam Joy Singh
**Department:**
Department of Sports Medicine, RIMS, Imphal
**Study Duration:**
-
**Initiation:** October 2024
-
**Completion:** September 2025
**Novelty of the Study:**
This study focuses on the effectiveness of PRP injections, administered under ultrasound guidance, specifically for Rockwood grade III acromioclavicular joint (ACJ) injuries. It employs the Double Spin Method for PRP preparation and is the first randomized controlled trial (RCT) of its kind conducted in India.
**Study Design:**
Randomized Controlled Trial (RCT)
**Objective:**
To assess the effectiveness of ultrasound-guided PRP injection compared to conservative management in improving pain and function in athletes with Rockwood grade III ACJ injuries of the shoulder.
**Participants:**
-
**Sample Size:** 60 participants, calculated based on a previous study by Windhamre HB et al.
-
**Recruitment:** Patients attending the Sports Medicine OPD at RIMS, Imphal, on specific weekdays, who meet the inclusion criteria, will be recruited through convenience sampling.
**Randomization:**
Block randomization method will be used.
**Independent Variables:**
-
**Demographics:** Age, Gender, Sports Discipline, Duration of symptoms
-
**Interventions:**
-
Ultrasound-guided platelet-rich plasma injection
-
Conservative management
**Outcome Variables and Measurements:**
-
**Shoulder Pain:** Visual Analog Scale (VAS)
-
**Shoulder Function:** Constant Murley Score and Quick DASH scores
**Statistical Analysis Plan:**
-
**Descriptive Data:** Mean, frequency, percentage, and standard deviation
-
**Categorical Data:** Chi-square test
-
**Continuous Variables:** Student’s t-test
-
**Within-Group Comparison:** Repeated measures ANOVA
-
**Between-Group Comparison:** Student’s t-test
-
**Significance:** p-value < 0.05
**Contact Information:**
-
**Email:** sobhasinil@gmail.com
-
**Phone:** 8732030087
Name of
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
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Rockwood Type 3 Acromioclavicular Joint Dislocation in X-ray of bilateral acromioclavicular joint in Zanca view
- •Age group 18-35 years
- •Duration of injury within 4 weeks.
排除标准
- •Any associated fracture and rotator cuff injury
- •Any previous shoulder surgery
- •Local infection around the shoulder
- •Uncontrolled systemic diseases
- •Local corticosteroid injection within 8 weeks
- •Thrombocytopenia
- •Haemodynamic instability.
结局指标
主要结局
1. Shoulder pain measured by Visual Analogue Scale (VAS)
时间窗: 1st, 3rd, 6th, and 12th months
2. Shoulder function measured by Constant Murley Score (CMS)
时间窗: 1st, 3rd, 6th, and 12th months
次要结局
- Shoulder function measured by Quick Dash scores(1st, 3rd, 6th, and 12th months)
研究者
Laimujam Sobhasini Devi
Regional Institute of Medical Sciences, Imphal, Manipur