Painful Inflammatory Carpometacarpal-1 osteoArthritis treated with intraarticular Steroids, Saline or an Occupational therapy intervention: the PICASSO trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 354

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Effect of interventions on pain, physical function, stiffness, grip strength, disease activity, self-efficacy, patient satisfaction and health-related quality of life, Effect of interventions on inflammation and bone marrow lesions, Effect of interventions on structural progression, Adverse events of interventions, Effect of interventions on cost-effectiveness;Primary end point(s): 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

Secondary Outcome Measures