Botulinum toxin injections for thumb osteoarthritis pain relief
Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb
This study is testing if Botulinum toxin injections can help relieve pain and improve movement in people with thumb osteoarthritis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, Paca) |
| Trial ID | NCT04829565 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intra-articular Botulinum toxin injections in reducing pain and improving function in patients with rhizarthrosis, a form of osteoarthritis affecting the thumb. The study will involve a monocentric randomized controlled trial comparing the effects of Botulinum toxin against a placebo. Participants will be assessed based on their pain levels and functional capabilities before and after the treatment. The trial aims to provide insights into the analgesic properties of Botulinum toxin in this specific joint condition.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with diagnosed rhizarthrosis and significant pain levels who have not responded to standard analgesic treatments.
Not a fit: Patients who have not been diagnosed with rhizarthrosis or those who have not experienced significant pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain and enhance the quality of life for patients suffering from thumb osteoarthritis.
How similar studies have performed: While there have been limited studies on Botulinum toxin for knee and ankle osteoarthritis, this specific application for thumb osteoarthritis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Nice, Paca
- CHU de Nice — Nice, Paca, France (Recruiting)
Study contacts
- Principal investigator: Pierre Blanc — Centre Hospitalier Universitaire de Nice
- Study coordinator: Pierre Blanc
- Email: blanc.p@chu-nice.fr
- Phone: 0492039655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.