Clinical Trials Directory

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

TypeNameDescription
DRUGInjection of triamcinolone acetonide into the CMC-1 jointintraarticular injection with triamcinolone acetonide
BEHAVIORALMultimodal Occupational therapy for CMC-1 joint OAPatient education, instructions about hand exercises, orthosis and training
DRUGPlaceboIntraarticular 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.