Clinical trial: Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis (NCT03225911)

Eligibility criteria:
Inclusion Criteria:

          -  1- Mild knee pain during walking on flat surface diagnosis via KOOS questionnaire (3
             out of 10) because our aim of the study to reduce pain with combined treatment and
             pain lower than 3 out of 10 score might not allow to compared the pain reduction
             between the group.

             2- Definitive medial joint narrowing higher or equal to the lateral side and
             osteophytes on X-Ray A-P or PA view in weight bearing position if possible.

             3- Medial joint tenderness either by patient's indication or the clinician under the
             clinical examination indicating tenderness in the tibiofemoral joint.

             4- K-L grade 2 or 3 of plain radiographs. If the patient has had arthroscopy or MRI as
             their usual clinical care. Indication of grade 1 osteoarthritis pulse the radiological
             plain x-ray will be used.

             5- Being able to walk without assisted devices for 100 meters non-stop because he or
             she will not be able to complete this study protocol.

        Exclusion Criteria:

          -  1- More pain localized to patellpfemoral or lateral joint than the medial knee side on
             examination.

             2- Tricompartmental knee osteoarthritis. 3- K-L grade 4 or higher. 4- Neurological or
             orthopaedic situations known to affect the ability to walk. 5- Tibial osteotomy or any
             other realignment operation. 6- Total knee replacement. 7- Any condition
             contraindicates orthosiss (sleeve or insole) use. 8- Steroid injection to affected
             intra-articular knee joint space in the previous month.

             9- Previous or current use of any oththosis. 10- Participants with 30 BMI and higher
             will be excluded because previous study showed that individuals with 33 BMI.

             11- Lower than 35 years and higher than 85 as this period was identified to highest
             incidence period (Losina et al., 2013). Although individuals with 86 and higher has
             high prevalence to the knee OA, exclusion this population was important due to high
             amount of walking and balance test.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 85 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? Entailment