Clinical trial: Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint (NCT00612248)

Eligibility criteria:
Inclusion Criteria:

          -  clinical and radiological diagnosis of idiopathic Grade II and III OA of the TMC joint
             on the dominant hand;

          -  either gender;

          -  over 40 years of age;

          -  pain in the base of the thumb of the dominant hand greater than three and less than or
             equal to seven on the 0 to 10-cm visual analogue scale (VAS) for pain.

        Exclusion Criteria:

          -  severe deformities of the dominant hand that did not allow gripping between the first,
             second and third fingers;

          -  deformities of distal interphalangeal joint;

          -  use of a splint on the thumb in the previous six months;

          -  surgery on the hand under study in the previous six months or scheduled in the
             upcoming six months;

          -  allergy to the splint material;

          -  incapacity to respond to the questionnaire and perform the tests;

          -  geographic inaccessibility;

          -  injections in the hand under study in the previous six months;

          -  other associated diseases such as carpal tunnel syndrome, fractures in the carpus,
             tendonitis, chronic inflammatory arthropathy;

          -  alterations in the use of anti-inflammatory medication and analgesics in the previous
             three months.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 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