Clinical trial: The Effects of Specialized Footwear in Osteoarthritis (NCT01597830)

Eligibility criteria:
Inclusion Criteria:

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

          -  Symptomatic OA of the knee, 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 by the subject 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.

        Exclusion Criteria:

          -  Inability or unwillingness to wear study shoes for at least 6 hours/day for 6
             days/week

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

          -  Presence of clinically significant OA of the hip or ankle or pain greater than 20 mm
             at these sites (WOMAC).

          -  > 3 degrees valgus or >12 degrees varus deformity of either knee, defined by the
             mechanical axis (hip-knee angle).

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

          -  Concurrent systemic inflammatory arthropathy,

          -  Prior knee or hip arthroplasty, or surgical arthroscopy of either knee within previous
             3 months or history of fracture of either lower extremity within 6 months of study
             entry.

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

          -  Intra-articular injection in the index knee: steroids within 6 weeks, hyaluronan
             derivatives within 4 months.

          -  Pregnant subjects will be excluded because of the X-rays required.

          -  Any medical condition that, in the opinion of the PI, would render the subject unable
             to complete the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



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