Clinical trial: Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA) (NCT00350896)

Eligibility criteria:
Inclusion Criteria:

          -  Pain at the base of the thumb 30 mm on VAS

          -  Patient aged 45 and < 75 years old

          -  At least 2 of the 5 items on the trapeziometacarpal joint radiograph osteophytes

          -  joint space narrowing

          -  subchondral bone sclerosis

          -  subchondral cysts

          -  At least 1 of the 2 clinical items trapeziometacarpal joint enlargement closure of the
             first web

        Exclusion Criteria:

          -  Post traumatic osteoarthritis

          -  Cristal arthropathy

          -  Inflammatory arthritis

          -  Neurologic disorder involving upper limb

          -  Psychiatric disorder needing treatment adaptation in the last 3 months

          -  Hand or wrist trauma within the last 2 months

          -  Previous hand surgery

          -  Unable to speak or write French

          -  Pregnancy

          -  Collagen diseases (Dupuytren, Marfan, Ehlers Danlos syndromes)

          -  Hand or wrist infiltration within 2 months

          -  Skin disease interfering with the wearing of the orthoses

          -  Having already worn a BTOA orthoses

          -  Having bilateral BTOA without predominant symptomatic side
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 75 Years

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? Entailment