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RECRUITING

NCT06084364

PHASE4

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

Sponsor: Diakonhjemmet Hospital

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

354

Start Date

2023-11-03

Completion Date

2028-10

Last Updated

2026-02-10

Healthy Volunteers

Conditions

Osteoarthritis Thumb

Interventions

DRUG

Injection of triamcinolone acetonide into the CMC-1 joint

intraarticular injection with triamcinolone acetonide

BEHAVIORAL

Multimodal Occupational therapy for CMC-1 joint OA

Patient education, instructions about hand exercises, orthosis and training

DRUG

Placebo

Intraarticular injection with saline

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

Locations (6)

Nordlands Hospital

Bodø, Norway

Haugesund Rheumatism Hospital

Haugesund, Norway

Diakonhjemmet Hospital

Oslo, Norway

Martina Hansens Hospital

Sandvika, Norway

Stavanger University Hospital

Stavanger, Norway

St Olavs Hospital

Trondheim, Norway