The study involved 60 participants – all of whom were 50 years of age or older and had moderately severe knee osteoarthritis. One-third (i.e. 20) of the patients received 5 weekly HYALGAN® injections, one-third of the patients received 3 weekly HYALGAN® injections and the final one-third of the patients received three weekly HYALGAN® injections and performed a home exercise program. The home exercise program involved two exercises that were designed to strengthen the muscles in front of the thigh known as quadriceps muscles that attach to the knee. The patients agreed to perform the exercises every other day after being shown a video of the exercises, shown a demonstration of the exercises, demonstrated the exercises themselves, and were given a handout that illustrated the exercises (please refer to the exercise diagrams). All of the patients kept a diary which recorded their level of pain and noted any pain medications that they were taking. In order to help isolate the effects of the HYALGAN® injections +/- the exercises for those patients who were in the exercise group, the patients agreed not to make any medication changes or change any other aspects of their treatment from the osteoarthritis while they were enrolled in the twelve month study.
The patients came into the doctor’s office for periodic study visits at which time they would bring in their diary and were questioned and examined. Although a few of the patients dropped out of the study, the majority completed the entire study.
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