Botox for thumb arthritis? new trial tests pain relief
NCT ID NCT04829565
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether injecting botulinum toxin into the thumb joint can reduce pain and improve function in people with thumb osteoarthritis (rhizarthrosis). Sixty adults with moderate to severe pain who have not responded to standard painkillers will receive either botulinum toxin or a placebo injection. The main goal is to measure pain changes after 3 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- botulinum toxin
- What this could lead to
- If it works, this could offer a new, non-surgical option to ease thumb arthritis pain and improve hand function.
- What could go wrong
- This is a small, early-phase trial with only 60 participants. The effect may be short-lived, and there is a risk of side effects like injection-site pain or muscle weakness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2021
- Expected to finish
-
May 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient \>18 years old * Patient with rhizarthrosis objectified by interrogation, radiography with at least 2 of the following criteria: osteophyte, joint space narrowing, subchondral sclerosis or geode * Patient who has had an X-ray of the wrist (face, profile and Kapandji incidence) to estimate the severity of the rhizarthrosis. * Patient with signed informed consent. * Visual analog scale (VAS) of pain \> 4 * Failure of well-conducted drug treatments with level 1 and 2 analgesics, anti-inflammatory drugs and orthotic devices * Patients must have stopped all corticosteroid or non-steroidal anti-inflammatory drugs therapy within the last 48 hours. * Patient affiliated with a Social Security plan * Patient who can understand the study instructions * Patient on effective contraception for more than one month according to the marketing authorization (Pill, intrauterine device, vaginal ring, contraceptive skin patch, hormonal subcutaneous implant) * Infertile patients in connection with surgery (tubal ligation, oophorectomy, adnexectomy, hysterectomy) Exclusion Criteria: * History of surgery of the thumb column * Patient who has received an intra-articular trapezoidal metacarpal injection of corticoids, botulinum toxin or hyaluronic acid or other product within the last 6 months. * Patient who has received a Botulinum toxin injection at any site within the last 3 months * Myasthenia or Lambert-Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe respiratory disorder or severe swallowing disorder * Patients with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose) * Patient with an infection or inflammation at the injection site concerned * Pregnant or breastfeeding women (a urine pregnancy test will be performed) * Patients with chronic inflammatory joint disease or microcrystalline pathology * Current participation or less than 30 days of participation in a clinical drug trial * Any medical or psychiatric condition that could prevent the proper understanding and conduct of the treatment and study (adult under guardianship) * Patient who wishes to discontinue contraception during the study * Patients at high risk of bleeding complications from the intra-articular injection (hemophilia, anticoagulant treatment, etc.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU de Nice
Nice, PACA, 06000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.