A Prospective Randomized Placebo-controlled Trial Comparing Platelet-rich Plasma and Corticosteroid Injection for Treatment of Trigger Finger
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Symptom resolution
研究概览
简要总结
Study purpose is to evaluate the effectiveness of Platelet-rich Plasma (PRP) injection in the treatment of trigger finger. We compare PRP to a corticosteroid (methylprednisolone) injection in a prospective randomized triple-blind placebo-controlled study.
Patients with clinically confirmed trigger finger are randomized (1:1:1 computer generated sequence with random block size) to three parallel groups and will receive an injection of either PRP, corticosteroid or placebo (0.9% saline) around the affected tendon sheath in a double-blind setting.
Baseline data is collected and is followed by a phone call at 1 month, and follow-up visits at 3, 6, 12 and 24 months after the intervention. Unveiling of the allocation is at 6 months post-intervention.
The primary outcome measures are:
- Symptom resolution
- Patient-Rated Wrist Evaluation
Secondary outcomes:
- Quick-Disabilities of the Arm, Shoulder and Hand
- Pain Visual Analogue Score
- Global improvement (7-step Likert-scale)
- Grip strength
- Finger range of motion
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75
- •Symptom duration > 3 months
排除标准
- •Rheumatoid arthritis or other condition requiring continuous oral corticosteroids
- •Previous history of surgery or injection to the affected ray
- •Alcohol or drug abuse
- •Mental instability
结局指标
主要结局
Symptom resolution
时间窗: 24 months
4-step Likert (0 = no response; 1 = partial response, but not satisfactory, warranting further treatment; 2 = partial response, satisfactory, not warranting further treatment; 3 = complete resolution of symptoms and signs)
Patient-Rated Wrist Evaluation
时间窗: 24 months
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
次要结局
- Global improvement(24 months)
- Quick-Disabilities of the Arm, Shoulder and Hand(24 months)
- Grip strength(24 months)
- Finger range of motion (ROM)(24 months)
- Pain (Visual Analogue Scale)(24 months)
研究者
Samuli Aspinen
Principal investigator
Töölö Hospital