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Taking peoplePhase 2/3

Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.

Key facts

Who runs it
Assistance Publique - Hôpitaux de Paris
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
Phase
Phase 2/3
People taking part
120 people, planned
Started
3 Dec 2025
Expected to end
Nov 2028
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • OnabotulinumtoxinA
  • Normal saline (placebo)
Record updated
3 April 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • • 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

Who cannot take part

  • • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • 2 intra-articular injections of onabotulinumtoxinATreatment being tested

    Treatment: OnabotulinumtoxinA

  • 1 intra-articular injection of onabotulinumtoxinA and 1 of normal salineTreatment being tested

    Treatment: OnabotulinumtoxinA and Normal saline (placebo)

  • 2 intra-articular injections of normal salinePlacebo, for comparison

    Treatment: Normal saline (placebo)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
3 April 2026