Phase
Condition
Pain
Inflammation
Osteoarthritis
Treatment
Injection of triamcinolone acetonide into the CMC-1 joint
Placebo
Multimodal Occupational therapy for CMC-1 joint OA
Clinical Study ID
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 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 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), psoriaticarthritis or gout) or other conditions that can better explain the hand pain (suchas thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, handinjury 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 othermedical condition that makes adherence to the study protocol difficult
Severe or uncontrolled infections
Known hypersensitivity to Triamcinolone acetonide (Kenacort) or any of theexcipients (sodium carboxymethylcellulose, sodium chloride, polysorbate, benzylalcohol, 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 isunable to comply with the study protocol and procedures
Study Design
Study Description
Connect with a study center
Nordlands Hospital
Bodø,
NorwaySite Not Available
Nordlands Hospital
Bodø 3160881,
NorwayActive - Recruiting
Haugesund Rheumatism Hospital
Haugesund,
NorwaySite Not Available
Haugesund Rheumatism Hospital
Haugesund 3153623,
NorwayActive - Recruiting
Diakonhjemmet Hospital
Oslo,
NorwaySite Not Available
Diakonhjemmet Hospital
Oslo 3143244,
NorwayActive - Recruiting
Martina Hansens Hospital
Sandvika,
NorwaySite Not Available
Martina Hansens Hospital
Sandvika 3140112,
NorwaySite Not Available
Stavanger University Hospital
Stavanger,
NorwaySite Not Available
Stavanger University Hospital
Stavanger 3137115,
NorwayActive - Recruiting
St Olavs Hospital
Trondheim,
NorwaySite Not Available
St Olavs Hospital
Trondheim 3133880,
NorwayActive - Recruiting

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