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Painful Inflammatory Carpometacarpal-1 osteoArthritis treated with intraarticular Steroids, Saline or an Occupational therapy intervention: the PICASSO trial
EU CTIS ID: 2023-505254-17-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.