Actively Recruiting

Phase 4
Age: 40Years - 85Years
All Genders
ID06084364

Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial

Led by Diakonhjemmet Hospital · Updated on 2026-02-10

354

Participants Needed

6

Research Sites

91 weeks

Total Duration

On this page

Sponsors

D

Diakonhjemmet Hospital

Lead Sponsor

V

Vestre Viken Hospital Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring the effects of intraarticular corticosteroid injections, saline injections, and a multimodal occupational therapy intervention in people with inflammatory carpometacarpal-1 osteoarthritis (CMC-1 OA). This trial, known as the PICASSO trial, aims to compare these pharmacological and non-pharmacological treatments head-to-head for efficacy and safety, focusing on patients with painful and inflammatory CMC-1 OA. The study will also investigate predictors of treatment effects and explore long-term safety and whether the occupational therapy can prevent or stop joint subluxation. Participants will be randomly assigned to one of three groups: a corticosteroid injection group receiving a single ultrasound-guided injection of triamcinolone acetonide at baseline with a possible repeat at 12 weeks if pain and inflammation persist; a placebo group receiving a saline injection under the same conditions; or an occupational therapy group involving patient education, hand exercises, training using the Happy Hands app, and use of day and night orthosis over a 12-week period. Dosage may be adjusted if resistance is noted during injections. During the study, participants will be assessed for pain during thumb activities at 4 and 12 weeks as the primary outcome. Additional evaluations include pain at rest and during activities in finger joints, hand function indexes, disease activity reports, joint tenderness, grip strength, medication use, ultrasound assessments, and safety monitoring up to 104 weeks. The study uses ultrasound guidance, questionnaires, and clinical exams to monitor disease progression and treatment effects, with follow-ups continuing for up to two years.

CONDITIONS

Brief Title

Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult men and women aged 40 to 85 years
  • Osteoarthritis in the target CMC-1 thumb joint confirmed by X-ray or ultrasound
  • Inflammation in the CMC-1 joint shown by ultrasound (grey scale synovitis grade 1-3)
  • Pain score of 3 or higher on a 0-10 scale at rest or during activities at both pre-screening and screening
  • Assessed as eligible for use of Kenacort-T (triamcinolone acetonide)
Not Eligible

You will not qualify if you...

  • Use of thumb orthosis on most days or structured hand exercises within the last 12 weeks
  • Intraarticular injections in the target CMC-1 joint within the last 12 weeks
  • More than 3 previous corticosteroid injections in the target CMC-1 joint
  • Use of oral, intramuscular, or intravenous steroids within the last 12 weeks
  • Previous surgery on the target CMC-1 joint
  • Planned hand surgery in the next 24 weeks
  • Unwillingness to stop using oral or topical NSAIDs on the hands during the next 12 weeks
  • Presence of systemic inflammatory joint diseases or other conditions explaining hand pain
  • Diagnosis of fibromyalgia or psoriasis
  • Infection, skin disease, or wounds at the injection site
  • Serious medical conditions, cognitive issues, substance abuse, or other factors affecting study adherence
  • Severe or uncontrolled infections
  • Known allergy to triamcinolone acetonide or its components
  • Participation in another clinical study
  • Use of digitalis glycosides
  • Vaccination with live virus vaccine within the last 2 weeks
  • Inability to speak or understand Norwegian
  • Known or planned pregnancy within the next 6 months
  • Any condition judged by the investigator to prevent compliance with the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive either a single ultrasound-guided intraarticular injection of triamcinolone acetonide or saline into the CMC-1 joint at baseline, with a possible repeat injection after 12 weeks if pain and inflammation persist. Alternatively, participants undergo a 12-week multimodal occupational therapy program including education, hand exercises, orthosis use, and training with the Happy Hands app.

Visits at baseline, Week 4, and Week 12 for assessments

Follow-up

Duration - Up to 104 weeks

Participants are monitored for safety, pain, and joint health up to 104 weeks after treatment to assess long-term outcomes and any additional injections if needed.

Visits at Week 24 and Week 104

Trial Site Locations

Total: 6 locations

1

Nordlands Hospital

Bodø, Norway

Actively Recruiting

2

Haugesund Rheumatism Hospital

Haugesund, Norway

Actively Recruiting

3

Diakonhjemmet Hospital

Oslo, Norway

Actively Recruiting

4

Martina Hansens Hospital

Sandvika, Norway

Active, Not Recruiting

5

Stavanger University Hospital

Stavanger, Norway

Actively Recruiting

6

St Olavs Hospital

Trondheim, Norway

Actively Recruiting

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Research Team

I

Ida Kristin Haugen, MD, PhD

M

Marthe Gløersen, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

Study protocol for the PICASSO trial: A randomized placebo-controlled trial to investigate the efficacy and safety of intraarticular steroid injections and an occupational therapy intervention in painful inflammatory carpometacarpal-1 osteoarthritis.

Marthe Gløersen, Ingvild Kjeken, A T Tveter...

https://pubmed.ncbi.nlm.nih.gov/39669005