NCT04218591已完成不适用
A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in patient-rated pain on load
研究概览
简要总结
Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthritis in the thumb base.
- •Radiological Eaton Littler class 1-
- •Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.
排除标准
- •Rheumatoid arthritis.
- •Ongoing infection in the hand or wrist.
- •History of gout or pseudo gout.
- •Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- •Intra-articular injection in the affected joint within 6 months.
- •Eaton Littler class 4 (STT joint involved).
研究组 & 干预措施
Saline
Placebo Comparator
Intra-articular injection Saline
干预措施: Placebo (Other)
PRP
Active Comparator
Intra-articular injection PRP
干预措施: PRP (Other)
结局指标
主要结局
Change in patient-rated pain on load
时间窗: 3 and 6 months after injection.
Numerical rating scale 0-10p (10=worst possible pain).
次要结局
- Change in Nelson Thumb score(3 and 6 months after injection.)
- Change in Patient-rated Wrist and Hand Evaluation (PRWHE)(3 and 6 months after injection.)
- Change in thumb strength(3 and 6 months after injection.)
- Change in EQ-5D(3 and 6 months after injection.)
- Change in Disability of the Hand, Arm and Shoulder (DASH) score(3 and 6 months after injection.)
- Change in Pain Catastrophizing Score (PCS).(3 and 6 months after injection.)
- Change in Hospital Anxiety and Depression Score (HADS),(3 and 6 months after injection.)
- Change in thumb range of motion(3 and 6 months after injection.)
研究者
Maria Wilcke
Principal Investigator
Karolinska Institutet
研究点 (1)
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