Clinical trial: Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb (NCT04829565)

Eligibility 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.)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? 1