Clinical trial: Knee Bracing for People With Patellofemoral Osteoarthritis (NCT00381563)

Eligibility criteria:
Inclusion Criteria:

          -  Knee pain on most days

          -  Either isolated patellofemoral osteoarthritis or mixed patellofemoral and tibiofemoral
             osteoarthritis, as based on x-ray

        Exclusion Criteria:

          -  Bed- or chair-bound, usually uses an ambulation aid to walk (e.g., cane, crutch, or
             walker), or uses a wheelchair

          -  Pain emanating more from the back or hip than from the knee, as determined by
             screening questionnaire

          -  Low pain score on the visual analog scale (VAS) (less than 4 out of 10)

          -  Plans to move from the area within 10 months of study screening

          -  Symptomatic comorbid disease that limits activities more than knee pain does, as
             determined by screening questionnaire (e.g., congestive heart failure, chronic
             obstructive pulmonary disease)

          -  Receiving corticosteroid injections in the month before study entry, or receiving
             hyaluronan in the 6-month period before study entry. No other treatments will result
             in exclusion, although for patients taking glucosamine and/or chondroitin and/or a
             non-steroidal anti-inflammatory drug (NSAID), they must have taken these treatments
             for at least 2 months before study entry and must commit to not start a new treatment
             during the study.

          -  Bilateral total knee replacements or plans for a total knee replacement of the
             affected knee in the next 6 months

          -  Morbidly obese (body mass index greater than 35), as brace fitting and prevention of
             slippage of the brace will be difficult

          -  Known other causes of arthritis, including rheumatoid arthritis, systemic lupus
             erythematosus, gout, psoriatic arthritis, and pseudogout

          -  Skin breakdown at the site where the brace will be applied

          -  Failure to pass the run-in test, or the brace falls down the leg during the run-in
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