Clinical trial: Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions (NCT03760380)

Eligibility criteria:
Inclusion Criteria:

          -  Chronic, OA-related knee pain

          -  Diagnosis of medial compartment knee OA (unilateral or bilateral)

          -  Moderate pain of ≥4 out of 10 points while performing a weight-bearing activity

          -  Kellgren and Lawrence score of 2, 3, or 4 evidenced on routine, standard-of-care x-ray
             within the last 2 years prior to enrollment

          -  Able to walk unassisted for at least 10 minutes at a time

          -  Wear a Women's shoe size of 6.5 to 13 or a Men's shoe size of 5 to 12.

        Exclusion Criteria:

          -  Patients suffering from acute septic or inflammatory arthritis

          -  Unstable cardiovascular, orthopaedic, or neurological conditions, uncontrolled
             diabetes, or any condition that would preclude exercise in moderate duration, moderate
             workload trials

          -  Received a corticosteroid injection or invasive procedures within prior 6 months of
             the study

          -  History of avascular necrosis in the knee

          -  History of knee buckling

          -  Joint replacement in any lower extremity joint that has not optimally recovered (e.g.
             still causes significant pain or affects mobility) as determined by the PI.

          -  Experienced more than 3 falls within the last year

          -  Currently using any knee brace on a regular basis for the knee pain, with the
             exception of basic knee sleeves

          -  Pathological osteoporotic fracture

          -  Severe symptomatic degenerative arthritis in lower limb joints other than the knees

          -  Severe back pain, prior spinal fusion or spinal deformity that would affect gait

          -  Major cardiac or pulmonary conditions and any orthopedic limitation that precludes
             their ability to independently walk for 10 minutes or longer

          -  Knee flexion contracture greater than 15°

          -  Knee flexion of less than 90°

          -  Any major injury to either knee within the prior 12 months

          -  Currently enrolled in a supervised physical therapy program
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.
Subject must be at most 75 Years

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