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

Diakonhjemmet Hospital

Status and phase: Enrolling; Phase 4

Conditions: Osteoarthritis Thumb

Treatments: Drug: Placebo; Behavioral: Multimodal Occupational therapy for CMC-1 joint OA; Drug: Injection of triamcinolone acetonide into the CMC-1 joint

Study type: Interventional

Funder types: Other

Identifiers

NCT06084364

2023-505254-17-00

Details and patient eligibility

About

A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis

Full 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).

Enrollment: 354 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- 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

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 or intramuscular 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 (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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

354 participants in 3 patient groups, including a placebo group

Intraarticular corticosteroid injection (IACS)

Experimental group

Description:

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.

Treatment:

Drug: Injection of triamcinolone acetonide into the CMC-1 joint

Saline injection

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Occupational Therapy intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Multimodal Occupational therapy for CMC-1 joint OA