Efficacy of Corticosteroid Versus Platelet-Rich Plasma Injections in the Treatment of Shoulder Tendinopathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
Shoulder tendinopathy is a common condition that causes shoulder pain and limits daily activities. It often results from damage or overuse of the rotator cuff tendons. Treatment typically includes rest, physical therapy, anti-inflammatory medications, and sometimes injections.
This clinical trial aims to compare the effectiveness of two types of injections for treating simple shoulder tendinopathy:
Corticosteroid injections, which reduce inflammation and provide quick pain relief, but may have only short-term effects.
Platelet-Rich Plasma (PRP) injections, a newer treatment made from the patient's own blood, which may promote long-term healing.
The study is being conducted at the Rheumatology Department of Charles Nicolle Hospital in Tunis, Tunisia. A total of 60 adult patients with shoulder tendinopathy will be randomly assigned to receive either a corticosteroid injection or a PRP injection.
Participants will be evaluated before the injection (baseline), after one week, and after three months. The researchers will assess pain levels using a visual analog scale (VAS), and shoulder function using validated questionnaires (DASH and SPADI scores).
The goal is to determine which treatment provides better pain relief and functional improvement over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older
- •Diagnosed with simple tendinopathy of the shoulder confirmed by clinical examination and imaging
- •Experiencing shoulder pain for at least 4 weeks
- •Able to provide informed consent
排除标准
- •Previous shoulder surgery on the affected side
- •Presence of rotator cuff tear or severe shoulder pathology
- •Systemic inflammatory diseases (e.g., rheumatoid arthritis)
- •Recent corticosteroid injection in the affected shoulder (within last 3 months)
- •Contraindications to corticosteroids or PRP treatment
- •Pregnancy or breastfeeding
研究组 & 干预措施
Corticosteroid Injection
Participants in this arm will receive a single infiltration of corticosteroids into the affected shoulder tendon. Corticosteroids are anti-inflammatory medications commonly used to reduce pain and inflammation in tendinopathies. The injection aims to provide rapid pain relief and improve shoulder function. Patients will be monitored for pain reduction and functional improvement at one week and three months after the injection.
干预措施: Corticosteroid Injection (Procedure)
Platelet-Rich Plasma (PRP) Injection
Participants in this arm will receive a single infiltration of Platelet-Rich Plasma (PRP) into the affected shoulder tendon. PRP is prepared from the patient's own blood and contains growth factors that may promote tissue healing and regeneration. This treatment aims to provide longer-term pain relief and functional improvement. Patients will be evaluated for pain and shoulder function at one week and three months following the injection.
干预措施: platelet-rich plasma injection (Procedure)
结局指标
主要结局
Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI)
时间窗: baseline, 1 week, 3 months
The SPADI score ranges from 0 to 100. Higher scores indicate greater pain and disability.
Change in shoulder function measured by the Disabilities of the Arm, Shoulder and Hand (DASH) score
时间窗: baseline, 1 week and 3 months
The DASH score ranges from 0 to 100. Higher scores indicate greater disability (worse function).
Change in pain intensity measured by Visual Analog Scale (VAS)
时间窗: baseline, 1 week, 3 months
The Visual Analog Scale (VAS) ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain". Higher scores represent worse pain outcomes.
次要结局
未报告次要终点
研究者
Selma Bouden
assistant doctor
Hopital Charles Nicolle