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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

Qualifiers

• 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;

Disqualifiers

• 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;

Trial design

Treatments tested in this trial

  • OnabotulinumtoxinA
  • Normal saline (placebo)

Treatment groups

120 Participants
are divided into 3 treatment groups

Locations

1
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 Cochin75014, ParisÎle-de-France Region, France

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator