CTIS2023-505254-17-00招募中1 期
Painful Inflammatory Carpometacarpal-1 osteoArthritis treated with intraarticular Steroids, Saline or an Occupational therapy intervention: the PICASSO trial
Diakonhjemmet Sykehus AS0 个研究点目标入组 354 人开始时间: 2023年6月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 354
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Men and women between 40-85 years of age, Osteoarthritis in target CMC-1 joint confirmed by radiographs or ultrasound examination, Inflammation in target CMC-1 joint confirmed by ultrasound (grey scale synovitis grade 1-3), Pain in target CMC-1 joint of at least 3 on a 0-10 Numeric rating scale (NRS) at rest or during activities at both pre-screening and screening, Patient is assessed as eligible for the proposed use of Kenacort-T
排除标准
- •Use of thumb orthosis on most of the days or structured hand exercises in the last 12 weeks, Diagnosis of psoriasis, Infection, skin disease or wounds at joint injection site, Serious comorbidities, cognitive dysfunction, substance/alcohol abuse or any other medical condition that makes adherence to the study protocol difficult, Severe or uncontrolled infections, Known hypersensitivity to Triamcinolone acetonide (Kenacort) or any of the excipients (sodium carboxymethylcellulose, sodium chloride, polysorbate, benzyl alcohol, sodium hydroxide or hydrochloric acid), Use of digitalis glycosides, Included in another clinical study, Patients vaccinated or immunized with live virus vaccines in the last 2 weeks, Not being able to speak or understand Norwegian, Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures, Intraarticular injections in the target CMC-1 joint in the last 12 weeks, Known pregnancy or planned pregnancy in the next 6 months, More than three previous IACS injections in the target CMC-1 joint, Use of oral, intramuscular, or intravenous steroids in the last 12 weeks, Previous surgery of the target CMC-1 joint, Planned hand surgery in the coming 24 weeks, Refuse to quit using oral or topical NSAIDs (such as ibuprofen, diclofenac, etoricoxib, naproxen) in the next 12 weeks, Systemic inflammatory joint diseases (including but not limited to rheumatoid arthritis (RA), psoriatic arthritis or gout) or other conditions that can better explain the hand pain (such as thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, hand injury in previous six months, or palmar tenosynovitis/trigger finger), Diagnosis of fibromyalgia
研究者
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