Clinical trial: Using Pressure Detecting Insoles to Reduce Knee Loading (NCT02955225)

Eligibility criteria:
Inclusion Criteria:

          -  Able and willing to give informed consent and comply with the study protocol.

          -  Symptomatic OA of the knee greater than 3 months, as defined by the American College
             of Rheumatology's Clinical Criteria for Classification and Reporting of OA of the
             Knee. If symptoms are bilateral, then the knee identified as more symptomatic will
             serve as the index knee.

          -  Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while
             walking on a flat surface (corresponding to question 1 of the visual analog format of
             the WOMAC).

          -  Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren
             and Lawrence (K-L) grading scale.

          -  Medial compartment OA, defined as either qualitative joint space narrowing of ≥ 1or
             the presence of medial bone cyst, sclerosis, or osteophyte.

          -  Able to walk at least 10 minutes without a break.

          -  Age of 40 years or older

        Exclusion Criteria:

          -  Unwillingness to wear study shoes for at least 6 hours/day for 6 days of the week

          -  Knee flexion contracture of > 15 degrees or inability to ambulate without assistance.

          -  Presence of clinical OA of the ankle or hip or ankle/hip pain>10 mm (WOMAC).

          -  Predominant lateral compartment OA, defined as narrowing of the lateral joint space in
             excess of the narrowing of the medial joint space in either knee.

          -  Concurrent systemic inflammatory arthropathy

          -  Prior knee or hip arthroplasty, or surgical arthroscopy within the previous 3 months.

          -  Intrinsic foot disease: hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar
             fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated
             particular footwear.

          -  Intra-articular knee injection: steroids within 6 wks, hyaluronan derivatives within 4
             mos.

          -  Body mass index greater than 38.
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