Clinical trial: Effect of Steroid Injections in a Knee With Osteoarthritis (NCT01230424)

Eligibility criteria:
Inclusion Criteria:

          -  Female or Male, Age ≥ 45 years

          -  Chronic knee discomfort based on affirmative response to the question "During the past
             12 months, have you had any pain, aching, or stiffness in or around your knee(s) on
             most days for at least one month?"

          -  Baseline (Month 0) Pain score >2 on at least one of the WOMAC weight-bearing pain
             questions; and total weight-bearing pain score <8

          -  Tibiofemoral or patellofemoral OA on posterior-anterior weight-bearing semi-flexed or
             lateral knee radiographs with severity equivalent to Kellgren and Lawrence grade 2 or
             3

          -  Evidence of synovitis on ultrasound at screening

          -  Clinical examination confirming knee pain or discomfort referable to the knee joint

          -  Prepared to discontinue NSAID(s)/analgesic(s) for 2 days prior to each assessment

        Exclusion Criteria:

          -  Prior septic (study) knee joint

          -  Prior reconstructive surgery in the study knee

          -  Prior osteonecrosis (avascular necrosis of bone)

          -  Chronic use of oral corticosteroids; knee intra-articular corticosteroid injection
             within 3 months of Month 0 (baseline) visit

          -  Ongoing use of doxycycline, indomethacin, glucosamine and/or chondroitin; or use of
             these within 2 months of Screening visit

          -  Evidence of other inflammatory joint disease (e.g., gout, CPPD)

          -  Serious medical conditions or impairments that, in the view of the investigator, would
             obstruct their participation in the trial such as uncontrolled diabetes, uncontrolled
             hypertension, opiate dependency

          -  Plan to permanently relocate from the region, or take an extended vacation for greater
             than 3 months during the trial period

          -  Planned arthroscopy and/or arthroplasty in the study knee.

          -  Any contra-indication to having an MRI

          -  Inability to speak or comprehend English
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.


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