Last updated: January 4, 2024
Sponsor: Diakonhjemmet Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Osteoarthritis
Treatment
Injection of triamcinolone acetonide into the CMC-1 joint
Placebo
Multimodal Occupational therapy for CMC-1 joint OA
Clinical Study ID
NCT06084364
2023-505254-17-00
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 activitiesat both pre-screening and screening.
- Patient is assessed as eligible for the proposed use of Kenacort-T
Exclusion
Exclusion Criteria:
- Use of thumb orthosis on most of the days or structured hand exercises in the last 12weeks
- 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), psoriaticarthritis or gout) or other conditions that can better explain the hand pain (such asthoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, hand injury inprevious 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 othermedical 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, sodiumhydroxide 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 isunable to comply with the study protocol and procedures
Study Design
Total Participants: 354
Treatment Group(s): 3
Primary Treatment: Injection of triamcinolone acetonide into the CMC-1 joint
Phase: 4
Study Start date:
November 03, 2023
Estimated Completion Date:
November 30, 2027
Study Description
Connect with a study center
Nordlands Hospital
Bodø,
NorwayActive - Recruiting
Haugesund Rheumatism Hospital
Haugesund,
NorwayActive - Recruiting
Diakonhjemmet Hospital
Oslo,
NorwayActive - Recruiting
Martina Hansens Hospital
Sandvika,
NorwayActive - Recruiting
Stavanger University Hospital
Stavanger,
NorwayActive - Recruiting
St Olavs Hospital
Trondheim,
NorwayActive - Recruiting
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