Clinical trial: Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain (NCT03806205)

Eligibility criteria:
Inclusion Criteria:

          -  According to the OA diagnostic criteria of knee joint, the side with higher WOMAC
             score is defined as observing knee joint for patients with both knees conforming to OA
             diagnostic criteria.

               1. Repeated knee pain in the past month

               2. X-ray showed narrowing of articular space, subchondral sclerosis and/or cystic
                  degeneration, and formation of osteophyte at articular margin.

               3. Joint fluid (> 2 times) is cool and sticky, WBC < 2000/ml

               4. Age over 40

               5. Morning stiffness less than 30 minutes

               6. Bone fricative (sensation) during exercise According to 1+2 or 1+3+5+6 or
                  1+4+5+6, OA of knee joint can be diagnosed.

               7. The informed consent has been signed

        Exclusion Criteria:

          -  (1) Joint pain caused by other causes (infection, hip, lumbar and other diseases) (2)
             Secondary arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) (3) Severe
             internal medical complications and other inability to participate in the research (4)
             Pain in other parts exceeds joint pain (5) Contraindications to diclofenac use: active
             peptic ulcer/allergy/induced asthma (6) Assessment may not complete the study
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? Entailment