Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial
Led by Diakonhjemmet Hospital · Updated on 2026-02-10
354
Participants Needed
6
Research Sites
91 weeks
Total Duration
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AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
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Frequently Asked Questions
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Sponsors
D
Diakonhjemmet Hospital
Lead Sponsor
V
Vestre Viken Hospital Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring the effects of intraarticular corticosteroid injections, saline injections, and a multimodal occupational therapy intervention in people with inflammatory carpometacarpal-1 osteoarthritis (CMC-1 OA). This trial, known as the PICASSO trial, aims to compare these pharmacological and non-pharmacological treatments head-to-head for efficacy and safety, focusing on patients with painful and inflammatory CMC-1 OA. The study will also investigate predictors of treatment effects and explore long-term safety and whether the occupational therapy can prevent or stop joint subluxation.
Participants will be randomly assigned to one of three groups: a corticosteroid injection group receiving a single ultrasound-guided injection of triamcinolone acetonide at baseline with a possible repeat at 12 weeks if pain and inflammation persist; a placebo group receiving a saline injection under the same conditions; or an occupational therapy group involving patient education, hand exercises, training using the Happy Hands app, and use of day and night orthosis over a 12-week period. Dosage may be adjusted if resistance is noted during injections.
During the study, participants will be assessed for pain during thumb activities at 4 and 12 weeks as the primary outcome. Additional evaluations include pain at rest and during activities in finger joints, hand function indexes, disease activity reports, joint tenderness, grip strength, medication use, ultrasound assessments, and safety monitoring up to 104 weeks. The study uses ultrasound guidance, questionnaires, and clinical exams to monitor disease progression and treatment effects, with follow-ups continuing for up to two years.
CONDITIONS
Brief Title
Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Who Can Participate
Age: 40Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
Adult men and women aged 40 to 85 years
Osteoarthritis in the target CMC-1 thumb joint confirmed by X-ray or ultrasound
Inflammation in the CMC-1 joint shown by ultrasound (grey scale synovitis grade 1-3)
Pain score of 3 or higher on a 0-10 scale at rest or during activities at both pre-screening and screening
Assessed as eligible for use of Kenacort-T (triamcinolone acetonide)
You will not qualify if you...
Use of thumb orthosis on most days or structured hand exercises within the last 12 weeks
Intraarticular injections in the target CMC-1 joint within the last 12 weeks
More than 3 previous corticosteroid injections in the target CMC-1 joint
Use of oral, intramuscular, or intravenous steroids within the last 12 weeks
Previous surgery on the target CMC-1 joint
Planned hand surgery in the next 24 weeks
Unwillingness to stop using oral or topical NSAIDs on the hands during the next 12 weeks
Presence of systemic inflammatory joint diseases or other conditions explaining hand pain
Diagnosis of fibromyalgia or psoriasis
Infection, skin disease, or wounds at the injection site
Serious medical conditions, cognitive issues, substance abuse, or other factors affecting study adherence
Severe or uncontrolled infections
Known allergy to triamcinolone acetonide or its components
Participation in another clinical study
Use of digitalis glycosides
Vaccination with live virus vaccine within the last 2 weeks
Inability to speak or understand Norwegian
Known or planned pregnancy within the next 6 months
Any condition judged by the investigator to prevent compliance with the study protocol
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive either a single ultrasound-guided intraarticular injection of triamcinolone acetonide or saline into the CMC-1 joint at baseline, with a possible repeat injection after 12 weeks if pain and inflammation persist. Alternatively, participants undergo a 12-week multimodal occupational therapy program including education, hand exercises, orthosis use, and training with the Happy Hands app.
Visits at baseline, Week 4, and Week 12 for assessments
Follow-up
Duration - Up to 104 weeks
Participants are monitored for safety, pain, and joint health up to 104 weeks after treatment to assess long-term outcomes and any additional injections if needed.
Study protocol for the PICASSO trial: A randomized placebo-controlled trial to investigate the efficacy and safety of intraarticular steroid injections and an occupational therapy intervention in painful inflammatory carpometacarpal-1 osteoarthritis.