Trials / Recruiting
RecruitingNCT06084364
Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial.
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 354 (estimated)
- Sponsor
- Diakonhjemmet Hospital · Academic / Other
- Sex
- All
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
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 (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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Injection of triamcinolone acetonide into the CMC-1 joint | intraarticular injection with triamcinolone acetonide |
| BEHAVIORAL | Multimodal Occupational therapy for CMC-1 joint OA | Patient education, instructions about hand exercises, orthosis and training |
| DRUG | Placebo | Intraarticular injection with saline |
Timeline
- Start date
- 2023-11-03
- Primary completion
- 2027-01-01
- Completion
- 2028-10-01
- First posted
- 2023-10-16
- Last updated
- 2026-02-10
Locations
6 sites across 1 country: Norway
Source: ClinicalTrials.gov record NCT06084364. Inclusion in this directory is not an endorsement.