BridgeMD
Tests treatment safety and results for Base-of-thumb Osteoarthritis
Official title Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
ClinicalTrials.gov ID: NCT06902805
What this study is testing
What is OnabotulinumtoxinA?
OnabotulinumtoxinA is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for base-of-thumb osteoarthritis.
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
- The main objective of this study 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.
- Phase 3: a large, late-stage study
- Which group you join is 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 18 and older
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...
- 1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis.
You likely can't join if
- Secondary osteoarthritis;
- History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;
- Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or clinical or subclinical signs of neuromuscular transmission disorders;
- Contra-indication to onabotulinumtoxinA;
- Neurological disorders involving the hands other than carpal tunnel syndrome;
- Collagen disorders involving the hands;
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.
- Patient able to give written informed consent prior to participation in the study
- Affiliation with a mode of social security (profit or being entitled).
- Negative pregnancy test in women of childbearing potential
- Secondary osteoarthritis;
- History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;
- Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or clinical or subclinical signs of neuromuscular transmission disorders;
- 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;
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Île-de-France Region, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Île-de-France Region, France. 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.