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New treatment option for Osteoarthritis Thumb
Official title Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
ClinicalTrials.gov ID: NCT06084364
What this study is testing
What is Injection of triamcinolone acetonide into the CMC-1 joint?
Injection of triamcinolone acetonide into the CMC-1 joint is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for osteoarthritis thumb.
Also referred to as Kenacort-T 40 mg/ml.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bodø, Norway
- Haugesund, Norway
- Oslo, Norway
- Sandvika, Norway
- Stavanger, Norway
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bodø, Norway; Haugesund, Norway; Oslo, Norway; Sandvika, Norway; Stavanger, Norway; Trondheim, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.