Status:
RECRUITING
Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Lead Sponsor:
Diakonhjemmet Hospital
Collaborating Sponsors:
Vestre Viken Hospital Trust
Helse Stavanger HF
Conditions:
Osteoarthritis Thumb
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief Summary
A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis
Detailed Description
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 (Pha...
Eligibility Criteria
Inclusion
- \- Adult (40-85 years of age) men and women
- In target joint:
- OA confirmed by radiographs or ultrasound examination
- Inflammation by ultrasound (grey scale synovitis grade 1-3)
- 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
Exclusion
- 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 or intramuscular 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 (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
- 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
Key Trial Info
Start Date :
November 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT06084364
Start Date
November 3 2023
End Date
June 1 2028
Last Update
September 19 2025
Active Locations (6)
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1
Nordlands Hospital
Bodø, Norway
2
Haugesund Rheumatism Hospital
Haugesund, Norway
3
Diakonhjemmet Hospital
Oslo, Norway
4
Martina Hansens Hospital
Sandvika, Norway