Clinical trial: Randomized Trial in knEe Osteoarthritis Using Low Intensity Ultrasound - Evaluating Feasibility (RELIEF) (NCT01623804)

Eligibility criteria:
Inclusion Criteria:

          -  over 40 years of age;

          -  have medial tibiofemoral compartment knee OA;

          -  have mild to moderate medial compartment radiographic OA severity (determined by the
             attending surgeon and/or Advanced Practice Physiotherapist on the basis of a standing
             x-ray or MRI scan depending upon which is available at initial consult);

          -  have stable ('not getting worse or better overall despite short-term fluctuations
             during the past three months') pain having an average intensity ≥ 3 and ≤ 8 on an
             11-point verbal numeric rating scale, VNRS) in one knee which is aggravated by
             activity and eased with rest;

          -  limited pain from other lower extremity joints; and

          -  no change in first line pain medication in the past 2 months and willingness to forego
             alterations in pain medication for the duration of the study unless deemed medically
             necessary.

        Exclusion Criteria:

          -  history of traumatic OA or previous surgical intervention in the knee or knee
             effusion;

          -  intra-articular injection of the knee in the previous 6 months;

          -  received ultrasound treatment for knee OA within the past 6 months;

          -  body weight changed ≥ 5% in the past 2 months;

          -  level of physical function insufficient to perform the required assessments or
             administer the intervention (e.g. intermittent claudication, severe peripheral
             neuropathy, active proliferative retinopathy, unstable cardiac or pulmonary disease,
             disabling stroke, chronic pain, arthritis in joints other than the study knee, bone
             fracture in the past 3 months);

          -  conditions listed as precautions or unknown safety risks for using the EXOGEN EXPRESS
             ultrasound device (pregnant or nursing women, individuals with thrombophlebitis,
             vascular insufficiency, abnormal skin sensitivity, sensory paralysis, open wound at
             the medial joint line of the knee, taking steroids/anti-coagulants, prescription
             non-steroidal anti-inflammatory, calcium channel blocker or applying the EXOGEN
             EXPRESS in close proximity to someone wearing a cardiac pacemaker);

          -  unable to read, write and/or understand English;

          -  other illness or reasons judged by the participant, clinicians or researchers to make
             participation inadvisable (e.g. plans to move or travel, cognitive deficit resulting
             in difficulty comprehending and complying with instructions, caregiving demands/lack
             of social support for participation);

          -  unwillingness to sign informed consent; or

          -  participation in a competing study.
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