Clinical trial: Exercise Therapy for Osteoarthritis Pain: How Does it Work? (NCT04362618)

Eligibility criteria:
Inclusion Criteria:

          1. KOA according to the clinical American College of Rheumatology (ACR) criteria. The
             clinical ACR criteria for KOA are: knee pain and at least 3 of the 6 following
             features: age ≥50, morning stiffness <30 minutes, crepitus, bony tenderness, bony
             enlargement, no palpable warmth. KOA will be confirmed with radiographs, including
             anterior-posterior (AP) and medio-lateral (ML) radiographs for imaging the
             tibiofemoral joint, and an axial view for imaging the patellofemoral joint. Kellgren
             and Lawrence (K&L) grading system for OA will be applied, with K&L grade 2 or higher
             defined as OA; radiographic KOA is defined as definite osteophytes and possible joint
             space narrowing.

          2. pain, nominated by the patient as 3 /10 or higher on a visual analogue scale on most
             days of the last 3 months

          3. aged ≥ 50 years.

        Exclusion Criteria:

          1. treatment with exercise therapy or joint infiltrations (e.g., corticosteroids,
             hyaluronic acid) in the preceding 6 months;

          2. being on a waiting list for knee replacement;

          3. any contra-indication for exercise therapy as established by the treating physician;

          4. corticosteroid infiltrations in the last 6 months;

          5. cognitive impairment (unable to understand the test instructions and/or Mini Mental
             State Examination score <23/30);

          6. unable to understand the Dutch language;

          7. inflammation unrelated to OA (e.g. due to acute or chronic infection) established by
             CRP>10mg/L.

          8. presence of a disorder and/or medication that influences pain and/or the immune system
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 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