Treatment options for thumb osteoarthritis

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

This study is testing whether steroid injections or a combination of therapy treatments can help people with painful thumb arthritis feel better and improve their hand function.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 354 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Diakonhjemmet Hospital (Academic / other)
• Locations: 6 sites (Bodø and 5 other locations)
• Trial ID: NCT06084364 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness and safety of intraarticular corticosteroid injections and a multimodal occupational therapy intervention for patients suffering from carpometacarpal-1 osteoarthritis. It is a placebo-controlled randomized controlled trial that aims to compare pharmacological and non-pharmacological treatments. The study includes patients with painful and inflammatory CMC-1 osteoarthritis, ensuring a tailored approach to treatment. Additionally, it will assess long-term safety and the potential of occupational therapy to prevent joint subluxation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-85 with confirmed CMC-1 osteoarthritis and significant inflammation and pain.

Not a fit: Patients with systemic inflammatory joint diseases or those who have recently undergone specific treatments for their thumb joint may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options that alleviate pain and improve function for patients with thumb osteoarthritis.

How similar studies have performed: Previous studies have shown promise in using corticosteroids and occupational therapy for osteoarthritis, but this specific approach is novel in its comprehensive comparison.

Eligibility criteria

Inclusion Criteria:

\- Adult (40-85 years of age) men and women

In target CMC-1 joint:

* OA confirmed by radiographs or ultrasound examination, and
* Inflammation by ultrasound (grey scale synovitis grade 1-3), and
* 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 Criteria:

* 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, intramuscular or intravenous 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 on the hands (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
* Severe or uncontrolled infections
* 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

Where this trial is running

Bodø and 5 other locations

• Nordlands Hospital — Bodø, Norway (Recruiting)
• Haugesund Rheumatism Hospital — Haugesund, Norway (Recruiting)
• Diakonhjemmet Hospital — Oslo, Norway (Recruiting)
• Martina Hansens Hospital — Sandvika, Norway (Active_not_recruiting)
• Stavanger University Hospital — Stavanger, Norway (Recruiting)
• St Olavs Hospital — Trondheim, Norway (Recruiting)

Study contacts

• Principal investigator: Marte Ingeborg Sæther — Martina Hansens Hospital
• Study coordinator: Ida Kristin Haugen, MD, PhD

Conditions Osteoarthritis Thumb; thumb; pain; inflammation; steroids; RCT; Occupational Therapy; Carpometacarpal-1