Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial.
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:
⁃ \- 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
Locations
Other Locations
Norway
Nordlands Hospital
RECRUITING
Bodø
Haugesund Rheumatism Hospital
RECRUITING
Haugesund
Diakonhjemmet Hospital
RECRUITING
Oslo
Martina Hansens Hospital
RECRUITING
Sandvika
Stavanger University Hospital
RECRUITING
Stavanger
St Olavs Hospital
RECRUITING
Trondheim
Contact Information
Primary
Ida Kristin Haugen, MD, PhD
Ida.Haugen@diakonsyk.no
+4795859884
Backup
Marthe Gløersen, MD
Marthe.Gloersen@diakonsyk.no
+4748109310
Time Frame
Start Date: 2023-11-03
Estimated Completion Date: 2028-06
Participants
Target number of participants: 354
Treatments
Experimental: Intraarticular corticosteroid injection (IACS)
A single ultrasound-guided intraarticular injection of 0.50 ml of 40 mg/ml triamcinolone acetonide at baseline. A smaller dosage can be considered if there is increased resistance during injection. The same injection procedure will be repeated after 12 weeks if there is pain (NRS≥3) and inflammation (grey scale synovitis grade 1-3) present in the CMC-1 joint.
Placebo_comparator: Saline injection
A single ultrasound-guided intraarticular injection of 0.50 ml of sodium chloride 9 mg/ml at baseline. A smaller dosage can be considered if there is increased resistance during injection. The same injection procedure will be repeated after 12 weeks if there is pain (NRS≥3) and inflammation (grey scale synovitis grade 1-3) present in the CMC-1 joint.
Experimental: Occupational Therapy intervention
Patient education, instructions about hand exercises and training in the Happy Hands app. Administration of day and night orthosis. The Happy Hands app involves a 12 week intervention.
Related Therapeutic Areas
Sponsors
Collaborators: St. Olavs Hospital, Vestre Viken Hospital Trust, Helse Stavanger HF, Nordlandssykehuset HF, Haugesund Rheumatism Hospital
Leads: Diakonhjemmet Hospital