A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain on load in thumb
研究概览
简要总结
This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.
详细描述
The aim of this study is to evaluate if high-concentration PRP injection decreases pain and disability in patients with thumb base osteoarthritis in the short-term and compare the effect to placebo.90 patients will be inlcuded (45+45). The primary outcome is pain on load (numerical rating scale) after 6 months. Patient-rated outcome measures, pinch grip and key pinch, range of motion of the CMC.1 joint will be assessed before treatment and at 3, 6 and months after the injection. Participants and assessors will be blinded.
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)
盲法说明
blind fold on participants. No infomration about given treatment to outcome assessors.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis 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 pseudogout in the hand
- •Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- •Chronic pain syndrome / centralized pain.
- •Intra-articular injection in the affected joint within 6 months.
- •Eaton Littler class 4 (symptomatic STT joint osteoarthritis).
研究组 & 干预措施
Platelet rich plasma (PRP)
High-concentration PRP injection PRP injection (0,6-1ml). Arthrex ACPmax system.
干预措施: Platelet rich plasma (PRP) (Procedure)
Placebo
intraarticular saline injection (0,6-1ml)
干预措施: Placebo (Other)
结局指标
主要结局
Pain on load in thumb
时间窗: 6 months after the first injection.
Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain)
次要结局
- HAKIR symptom score (HQ-8)(12 months)
- Nelson thumb score(12 months)
- key pinch and pinch strength(12 months)
- Radial and palmar abduction(12 months)
- Patient-rated Wrist and Hand (PRWHE) score(12 months)
- Patient-rated Wrist and Hand (PRWHE) score(6 months)
- Patient-rated Wrist and Hand (PRWHE) score(3 months)
- Nelson thumb score(3 months)
- Nelson thumb score(6 months)
- HAKIR symptom score (HQ-8)(3 months)
- HAKIR symptom score (HQ-8)(6 months)
- key pinch and pinch strength(3 months)
- key pinch and pinch strength(6 months)
- Radial and palmar abduction(3 months)
- Radial and palmar abduction(6 months)
研究者
Maria Wilcke
Associate profesoor
Karolinska Institutet