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

NCT ID: NCT06084364

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-03
• Study Completion Date: 2028-10-31

Brief 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

Osteoarthritis Thumb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Injection of triamcinolone acetonide into the CMC-1 joint

Intervention Type: DRUG

intraarticular injection with triamcinolone acetonide

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intraarticular injection with saline

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.

Group Type: EXPERIMENTAL

Multimodal Occupational therapy for CMC-1 joint OA

Intervention Type: BEHAVIORAL

Patient education, instructions about hand exercises, orthosis and training

Interventions

Injection of triamcinolone acetonide into the CMC-1 joint

intraarticular injection with triamcinolone acetonide

Intervention Type: DRUG

Multimodal Occupational therapy for CMC-1 joint OA

Patient education, instructions about hand exercises, orthosis and training

Intervention Type: BEHAVIORAL

Placebo

Intraarticular injection with saline

Intervention Type: DRUG

Other Intervention Names

Kenacort-T 40 mg/ml; Sodium chloride 9 mg/ml

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vestre Viken Hospital Trust

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

Haugesund Rheumatism Hospital

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Nordlandssykehuset HF

OTHER

Sponsor Role: collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ida Kristin Haugen

Rheumatologist, senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ida Kristin Haugen, MD, PhD

Role: STUDY_DIRECTOR

Diakonhjemmet Hospital

Marte Ingeborg Sæther

Role: PRINCIPAL_INVESTIGATOR

Martina Hansens Hospital

Elisabet Esperø

Role: PRINCIPAL_INVESTIGATOR

Haugesund Rheumatism Hospital

Katrine Brække Norheim

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Mari Hoff

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Göran Karlsson

Role: PRINCIPAL_INVESTIGATOR

Nordland Hospital

Locations

Nordlands Hospital

Bodø, , Norway

Site Status: RECRUITING

Haugesund Rheumatism Hospital

Haugesund, , Norway

Site Status: RECRUITING

Diakonhjemmet Hospital

Oslo, , Norway

Site Status: RECRUITING

Martina Hansens Hospital

Sandvika, , Norway

Site Status: ACTIVE_NOT_RECRUITING

Stavanger University Hospital

Stavanger, , Norway

Site Status: RECRUITING

St Olavs Hospital

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Ida Kristin Haugen, MD, PhD

Role: CONTACT

Ida.Haugen@diakonsyk.no

+4795859884

Marthe Gløersen, MD

Role: CONTACT

Marthe.Gloersen@diakonsyk.no

+4748109310

Facility Contacts

Göran Karlsson

Role: primary

Elisabet Esperø

Role: primary

Ida Kristin Haugen

Role: primary

Katrine Brække Norheim

Role: primary

Mari Hoff

Role: primary

References

Gloersen M, Kjeken I, Tveter AT, Kazemi A, Sexton J, Dziedzic K, Felson DT, Stamm TA, Guermazi A, Hermann-Eriksen M, Saether MI, Lundby K, Espero EL, Olsen M, Norheim KB, Fister EB, Hoff M, Uleberg JK, Midtgard IP, Andreassen T, Sjolie D, Sletten H, Hammer HB, Haugen IK; PICASSO study team. 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. Osteoarthr Cartil Open. 2024 Nov 19;7(1):100542. doi: 10.1016/j.ocarto.2024.100542. eCollection 2025 Mar.

Reference Type: DERIVED

PMID: 39669005 (View on PubMed)

Other Identifiers

2023-505254-17-00

Identifier Type: -

Identifier Source: org_study_id