Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial.
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
- 7
- 主要终点
- Pain during activities in thumb base joint
研究概览
简要总结
A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis
详细描述
The primary aim of the PICASSO trial is to examine the efficacy and safety of intraarticular corticosteroid injections and a multimodal occupational therapy intervention in patients with CMC-1 OA (Phase 1). By comparing available non-pharmacological and pharmacological treatments head-to-head, our results will be of interest to the range of health professionals who are involved in the management of CMC-1 OA patients. By including patients who are likely to benefit from the intervention (painful and inflammatory CMC-1 OA), appropriate dosage of drug and ultrasound-guided injections, our trial is more guarded against possible false negative results than previous studies. We will also explore predictors for treatment effects. Due to the heterogeneous presentation of OA, it is unlikely that one treatment will fit all, and treatment should be tailored to the patients´ clinical presentation. Second, we will explore the long-term safety of IACS, and whether the occupational therapy intervention can prevent or halt CMC-1 subluxation (Phase 2).
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participants and the occupational therapist who examine the patients are blinded for the content of the intraarticular injections. The rheumatologist who perform the intraarticular injection will not be blinded for the content.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Adult (40-85 years of age) men and women
- •In target CMC-1 joint:
- •OA confirmed by radiographs or ultrasound examination, and
- •Inflammation by ultrasound (grey scale synovitis grade 1-3), and
- •Pain 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
- •Intraarticular injections in the target CMC-1 joint in the last 12 weeks
- •More than 3 previous IACS 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
- •Do not want 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 (such as 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
- •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)
- •Included in another clinical study
- •Use of digitalis glycosides
- •Patients vaccinated or immunized with live virus vaccines in the last 2 weeks
- •Not being able to talk or understand Norwegian
- •Known pregnancy or planned pregnancy in the next 6 months
- •Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures
研究组 & 干预措施
Intraarticular corticosteroid injection (IACS)
A single ultrasound-guided intraarticular injection of 0.50 ml of 40 mg/ml triamcinolone acetonide at baseline. A smaller dosage can be considered if there is increased resistance during injection. The same injection procedure will be repeated after 12 weeks if there is pain (NRS≥3) and inflammation (grey scale synovitis grade 1-3) present in the CMC-1 joint.
干预措施: Injection of triamcinolone acetonide into the CMC-1 joint (Drug)
Saline injection
A single ultrasound-guided intraarticular injection of 0.50 ml of sodium chloride 9 mg/ml at baseline. A smaller dosage can be considered if there is increased resistance during injection. The same injection procedure will be repeated after 12 weeks if there is pain (NRS≥3) and inflammation (grey scale synovitis grade 1-3) present in the CMC-1 joint.
干预措施: Placebo (Drug)
Occupational Therapy intervention
Patient education, instructions about hand exercises and training in the Happy Hands app. Administration of day and night orthosis. The Happy Hands app involves a 12 week intervention.
干预措施: Multimodal Occupational therapy for CMC-1 joint OA (Behavioral)
结局指标
主要结局
Pain during activities in thumb base joint
时间窗: 4 and 12 weeks
Change in thumb base joint pain during activities last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.
次要结局
- Use of analgesics(Week 00, 04, 12, 24, and 104)
- Pain during activities in finger joints(Week 00, 04, 12, 24, 104)
- OMERACT-OARSI criteria responders(Week 00, 04, 12, 24, 104)
- Pain during activities in thumb base joint(All visits)
- Joint space narrowing(Week 00, 104)
- Use of healthcare services(Week 00, 12, 24, 104)
- MAP-Hand(Week 00, 04,12, 24 and 104)
- Pain in finger joints (hand figure)(Week 00, 04, 12, 24, 104)
- Arthritis self-efficacy scale(Week 00, 04, 12, 24, 104)
- Tender hand joints(Week 00, 04, 12, 24, 104)
- Bone marrow lesions in the CMC-1 joint(Week 00, 04)
- Pain at rest in finger joints(Week 00, 04, 12, 24, 104)
- Grip strength(Week 00, 04, 12, 24, 104)
- Use of NSAIDs(Week 00, 04, 12, 24, and 104)
- Osteophytes(Week 00, 104)
- Patient satisfaction(Week 04, 12)
- Swollen hand joints(Week 00, 04, 12, 24, 104)
- Synovitis in the CMC-1 joint(Week 00, 04)
- Structural progression(Week 00, 104)
- Subluxation of the CMC-1 joint(Week 00, 104)
- AUSCAN (Australian/Canadian hand index)(Week 00, 04,12, 24 and 104)
- Patient-reported overall disease activity(Week 00, 04, 12, 24, 104)
- Assessor-reported overall disease activity(Week 00, 04, 12, 24, 104)
- EuroQol 5 dimensions 5-levels (EQ-5D-5L)(Week 00, 04, 12, 24,104)
- Pain at rest in thumb base joint(Week 00, 04, 12, 24, 104)
- Ultrasound synovitis in the CMC-1 joint(Week 00, 04,12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.)
- Adverse events(Week 00, 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.)
- Serious adverse events(Week 00, 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.)
- Withdrawals because of adverse events(Week 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.)
研究者
Ida Kristin Haugen
Rheumatologist, senior researcher
Diakonhjemmet Hospital