2023-505254-17-00招募中4 期
Painful Inflammatory Carpometacarpal-1 osteoArthritis treated with intraarticular Steroids, Saline or an Occupational therapy intervention: the PICASSO trial
Diakonhjemmet Sykehus AS6 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2023年9月29日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 354
- 试验地点
- 6
- 主要终点
- Change in thumb base joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) after 4 weeks
研究概览
简要总结
To assess whether intraarticular corticosteroid (IACS) injections are superior to saline injections after 4 weeks, and compare the efficacy of IACS injections, saline injections and a multimodal occupational therapy intervention after 12 weeks in patients with painful inflammatory OA in the first carpometacarpal joint.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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 on the hands (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
结局指标
主要结局
Change in thumb base joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) after 4 weeks
Change in thumb base joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) after 4 weeks
Change in thumb base joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) after 12 weeks
Change in thumb base joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) after 12 weeks
次要结局
- Change in thumb base joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) (all visits)
- Change in finger joint pain during activities last 24 hours on a Numeric Rating Scale (NRS) (W00, W04, W12, W24, W104)
- Change in Australian/Canadian Ostearthritis Hand Index (AUSCAN) pain, stiffness and function subscales (W00, W04, W12, W24, W104)
- Number of OMERACT-OARSI criteria responders (W00, W04, W12, W24, W104)
- Change in measure of activity performance of the hand (MAP-Hand) (W00, W04, W12, W24, W104)
- Change in patient-reported overall disease activity in hands last 24 hours on a Numeric Rating Scale (NRS) (W00, W04, W12, W24, W104)
- Change in assessor-reported overall disease activity in hands on a Numeric Rating Scale (NRS) (W00, W04, W12, W24, W104)
- Change in pain in finger joints last 24 hours (hand figure) (W00, W04, W12, W24, W104)
- Change in grip strength (W00, W04, W12, W24, W104)
- Change in use of analgesics (W00, W04, W12, W24, W104)
- Change in use of NSAIDs (W00, W04, W12, W24, W104)
- Change in arthritis self-efficacy scale (W00, W04, W12, W24, W104)
- Number of responders regarding patient satisfaction (W04, W12)
- Change in EuroQol 5 dimensions 5-levels (EQ-5D-5L) (W00, W04, W12, W24, W104)
- Change in number of tender hand joints (W00, W04, W12, W24, W104)
- Change in number of swollen hand joints (W00, W04, W12, W24, W104)
- Change in ultrasound synovitis in the CMC-1 joint (W00, W04, W12, W24, INJ, W104)
- Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI (W00, W04)
- Change in bone marrow lesions in the CMC-1 joint on contrast-enhanced MRI (W00, W04)
- Change in structural progression by Kellgren-Lawrence (W00, W104)
- Change in osteophytes by OARSI atlas (W00, W104)
- Change in joint space narrowing by OARSI atlas (W00, W104)
- Change in subluxation of the CMC-1 joint (W00, W104)
- Number of adverse events (W00, W04, W12, W24, INJ, W104)
- Number of serious adverse events (W00, W04, W12, W24, INJ, W104)
- Number of withdrawals because of adverse events (W04, W12, W24, INJ, W104)
- Questions about use of healthcare services (W00, W12, W24, W104)
- Change in thumb base joint pain at rest last 24 hours on a Numeric Rating Scale (NRS) (W00, W04, W12, W24, W104)
- Change in finger joint pain at rest last 24 hours on a Numeric Rating Scale (NRS) (W00, W04, W12, W24, W104)
研究者
Sponsor contact person
Scientific
Diakonhjemmet Sykehus AS
研究点 (6)
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