Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection (Thumbs-up Study)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 主要终点
- Clinical pain improvement: VAS score
研究概览
简要总结
The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections improve pain and function in adults with thumb base osteoarthritis (CMC-I OA).
The main questions it aims to answer are:
Does a PRP injection reduce pain compared to a placebo (saline) injection? Does PRP improve hand function, strength, and thumb mobility? What adverse events occur following PRP treatment?
Researchers will compare PRP injections to a placebo injection (saline solution) to determine whether PRP is an effective treatment for CMC-I osteoarthritis.
Participants will:
Receive a single ultrasound-guided injection of PRP or placebo (saline) in the CMC-I joint.
Attend follow-up visits at 3, 6, 9, and 12 months for clinical assessments. Complete questionnaires on pain (VAS) and hand function (MHQ-DLV) at multiple time points.
Undergo physical examinations (grip strength, pinch strength, thumb motion). Undergo ultrasound evaluations to assess joint characteristics.
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, Care Provider)
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
- •Age 18 or older
- •Patients with an Eaton-littler score of I, II or III
- •Patients with uni- or bilateral CMC-I osteoarthritis
- •Non-responders to conservative therapy i.e., hand therapy and immobilisation after 3 months
排除标准
- •Aged below 18
- •Patients with an Eaton-littler score of IV (STT arthrosis)
- •Surgical interventions of the CMC-I joint
- •A known articular systemic disease (e.g. rheumatoid arthritis) or additional hand osteoarthritis/ tenosynovitis or metabolic disease like diabetes mellitus
- •Patients with an infectious arthritis of CMC-I joint
- •A known psychiatric condition
- •Neuropathic chronic pain syndrome
- •Intra articular injection 6 months prior to inclusion
- •Active use of statins
结局指标
主要结局
Clinical pain improvement: VAS score
时间窗: 3, 6, 9 and 12 months
次要结局
- Functional improvement: Opposition of the thumb (pollexograph)(3, 6, 9 and 12 months)
- Functional improvement: Kapandji score(3, 6, 9 and 12 months)
- Functional improvement: Michigan Hand Questionnaire (MHQ-DLV)(3, 6, 9 and 12 months)
- Functional improvement: Grip and pinch test(3, 6, 9 and 12 months)
研究者
Evi Loos
PhD Candidate
Goed Medisch Centrum