Clinical trial: Patterned Electrical Neuromuscular Stimulation and Therapeutic Exercise for Osteoarthritis of the Knee: Pilot Study (NCT00701506)

Eligibility criteria:
Inclusion Criteria:

          -  Patient may have evidence of osteoarthritis (radiographic and/or by patient symptoms
             report) in more than one joint, however, osteoarthritis of one knee has been the
             patient's primary complaint and the focus of treatment.

          -  Radiographic evidence, within 6 months of enrollment, of osteoarthritis of the knee
             receiving treatment.

          -  Kellgren and Lawrence osteoarthritis classification grade 1, 2 or 3 (i.e., indicative
             of cartilage still remaining in joint).

          -  Average rating of pain associated with osteoarthritis of knee greater than or equal to
             4 cm (on a 10 cm visual analog scale).

          -  Stiffness in knee(s) lasts less than 30 minutes (to demonstrate that stiffness is not
             from a more serious condition)

          -  Agrees to follow their randomized treatment plan and use the device.

          -  At least 18 years old.

          -  Signed informed consent.

          -  Erythrocyte Sedimentation rate greater than 40 mm/hour (Higher rates may be indicative
             of RA)

          -  Agrees to follow the randomized treatment plan and use of the stimulation device.

        Exclusion Criteria:

          -  Hypersensitivity to electrical stimulation.

          -  Undergone within 3 months of enrollment, corticosteroid or viscosupplementation (i.e.,
             hyaluronate) injections to the effected knee.

          -  If taking medications such as oral steroids, non-steroidal anti-inflammatories, or
             acetaminophen, patient has been on a stable dose for at least 3 months prior to
             enrollment. (The criteria should match the prior retrospective data studies.)

          -  If taking chondroprotective supplements (e.g., glucosamine and chondroitin sulfate),
             patient has been on a stable dose for at least 3 months prior of enrollment.

          -  Pathologic process at the knee (congenital defect or blunt trauma leading to
             structural defect such as torn anterior cruciate or meniscus ligaments).

          -  Problems due to mechanical/anatomical deformities (i.e., valgus greater than 5 degrees
             or varus greater than 1.5 degrees)

          -  Women who are, or plan to become pregnant during the clinical investigation.

          -  Known malignancy or cancer.

          -  Morbid obesity (BMI > 40).

          -  Serious or uncontrolled systemic illness (e.g., autoimmune disease, rheumatoid
             arthritis, diabetes mellitus or renal failure).

          -  Implanted devices such as a cardiac pacemaker or defibrillator

          -  Concurrent use of another electrical stimulation device for treatment of knee
             symptoms.

          -  Ongoing enrollment, or discontinued enrollment within the last 30 days, in another
             clinical trial for medical devices or biologic agents.

          -  Relationship other than medical (e.g., spouse or employee of investigator) with
             principal investigator(s) and their staff which may bias patient reports.

          -  Relationship with another person enrolled in the clinical investigation.

          -  Unable to complete the study per the investigational plan or unable to complete the
             case report forms.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 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