Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT06902805
Eligibility Criteria:
Inclusion 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
Exclusion Criteria:
* • 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06902805
Study Brief:
Protocol Section:
NCT06902805