NCT06084364 Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
| NCT ID | NCT06084364 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Diakonhjemmet Hospital |
| Condition | Osteoarthritis Thumb |
| Study Type | INTERVENTIONAL |
| Enrollment | 354 participants |
| Start Date | 2023-11-03 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 354 participants in total. It began in 2023-11-03 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis
Eligibility Criteria
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
Contact & Investigator
Ida Kristin Haugen, MD, PhD
STUDY DIRECTOR
Diakonhjemmet Hospital
Frequently Asked Questions
Who can join the NCT06084364 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Osteoarthritis Thumb. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06084364 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06084364 currently recruiting?
Yes, NCT06084364 is actively recruiting participants. Contact the research team at Ida.Haugen@diakonsyk.no for enrollment information.
Where is the NCT06084364 trial being conducted?
This trial is being conducted at Bodø, Norway, Haugesund, Norway, Oslo, Norway, Sandvika, Norway and 2 additional locations.
Who is sponsoring the NCT06084364 clinical trial?
NCT06084364 is sponsored by Diakonhjemmet Hospital. The principal investigator is Ida Kristin Haugen, MD, PhD at Diakonhjemmet Hospital. The trial plans to enroll 354 participants.