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

Summary

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.

Eligibility

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

Conditions3

Interventions2

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