Two Botox injections plus custom rigid splinting for painful base-of-thumb osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2/3 interventional trial compares three regimens combining ultrasound-guided intra-articular onabotulinumtoxinA (Botox®) injections and normal saline injections, all paired with custom-made rigid splinting, for symptomatic trapezometacarpal osteoarthritis. Participants receive two injections over the study period (either two Botox injections, one Botox plus one saline, or two saline injections) and are followed with the primary pain outcome measured six months after the first injection. Eligible participants must have radiographic evidence of trapezometacarpal osteoarthritis and a baseline pain score of at least 30/100. The procedures are delivered under ultrasound guidance at Assistance Publique - Hôpitaux de Paris (Hôpital Cochin).

Why it matters

Who can join: the full rules

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

Where it's running

• Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis du Pr François Rannou, Hôpital Cochin
  Paris, Île-de-France Region, France Recruiting

Study contacts

• Principal investigator: Christelle NGUYEN, MD,PhD — Organizational Affiliation: Université Paris Cité, Faculté de Santé | UFR de Médecine
• Study coordinator: Christelle NGUYEN, MD, PhD
• Email: christelle.nguyen2@aphp.fr
• Phone: 01 58 41 29 45

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.