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RHIBOT II - Medium- and long-term efficacy of two ultrasound-guided intra-articular injections of onabotulinumtoxinA (Botox®) combined with custom-made rigid splinting in painful base-of-thumb osteoarthritis : a randomized double-blind controlled trial in three-parallel arms
EU CTIS ID: 2024-515028-35-00
What this study is testing
Our main objective will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Individuals aged at least 18 years;
- • Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);
- • Pain involving the base of the thumb;
- • X-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpial joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts;
- • 1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis.
- • Affiliation with a mode of social security (profit or being entitled).
You likely can't join if
- • Secondary osteoarthritis;
- • Use of IM, IV or oral corticosteroids for up to 2 months.
- • Protected adults (including individual under guardianship by court order)
- • Pregnant women and lactation; lack of contraception for women of childbearing potential
- • Patient participating in another investigational therapeutic study
- • Patient unable to speak and read French
See the full eligibility criteria
- • Individuals aged at least 18 years;
- • Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);
- • Pain involving the base of the thumb;
- • X-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpial joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts;
- • 1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis.
- • Affiliation with a mode of social security (profit or being entitled).
- • Negative pregnancy test in women of childbearing potential
- • Secondary osteoarthritis;
- • Use of IM, IV or oral corticosteroids for up to 2 months.
- • Protected adults (including individual under guardianship by court order)
- • Pregnant women and lactation; lack of contraception for women of childbearing potential
- • Patient participating in another investigational therapeutic study
- • Patient unable to speak and read French
- • History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;
- • Contra-indication to onabotulinumtoxinA;
- • Neurological disorders involving the hands other than carpal tunnel syndrome;
- • Collagen disorders involving the hands
- • Osteoarthritis predominating at the scaphotrapezial joint on x-ray;
- • Bilateral trapezometacarpial osteoarthritis without a predominant painful side;
- • Hand or wrist trauma for up to 2 months;
- • Intra-articular treatments for up to 2 months;
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.