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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Osteoarthritis Thumb

In brief

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

Key facts

Study ID

NCT06084364

Run by

Diakonhjemmet Hospital

People needed

354

Starts

2023-11-03

Expected to finish

2028-10-01

Last updated by the study team

2026-02-10

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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