Clinical trial: Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis (NCT03187626)

Eligibility criteria:
Inclusion Criteria:

          -  Age ≥ 18 years old

          -  Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30

          -  Pain involving the base-of-thumb

          -  X-ray evidence of base-of-thumb osteoarthritis with at least 2 of the 4 following
             items involving the trapeziometacarpal joint : osteophytes, joint space narrowing,
             subchondral bone sclerosis or subchondral cysts

          -  1990 American College of Rheumatology classification criteria for hand osteoarthritis
             adapted to base-of-thumb osteoarthritis

          -  Medical examination

          -  Written consent

          -  Health insurance

          -  For women of childbearing age, a negative urinary pregnancy test

        Exclusion Criteria:

          -  History of thumb surgery

          -  History of inflammatory or crystal-associated rheumatic disease

          -  Neurological disorders involving the hands

          -  Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases

          -  Osteoarthritis involving the scaphotrapezial joint

          -  Hand or wrist trauma ≤ 2 months

          -  Hand or wrist intra-articular injections ≤ 2 months

          -  Contra-indication to botulinum toxin A injection or to splinting

          -  Cognitive or behavioral disorders making the assessment impossible

          -  Participant unable to speak, read and write french

          -  Bilateral BTOA without predominant symptomatic side

          -  Pregnancy and breast feeding

          -  Persons referred to in Articles L 1121-5; 6; 8; 9 of the Public Health Code (protected
             minors or adults, guardianship or trusteeship, etc.)

          -  Patient with epilepsy
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? Contradiction