The purpose of this study is to determine whether a functional electrical stimulation device, the SurgiStim3, decreases pain, pain medications and/or edema in patients undergoing anterior cruciate ligament repair.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Electrical stimulation device that provides interferential, high voltage pulsed current and neuromuscular waveforms in sequence. The device runs continuously for the first 2 days following surgery, then runs 3 times a day for 1 hour on days 3 through 42.
The placebo device is programmed to run for the same amount of time, at the same schedule, using the same waveforms as the functional device over the course of the 42 days. The placebo device, however, will only increase to 80% of the patient-set amplitude after a one minute set-up period and will only turn on for 6 seconds of every minute (3s ramp up, 1s on time, 2s ramp down).
Southern California Orthopedic Institute
Van Nuys, California, United States
pain
Time frame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
pain medications
Time frame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
edema
Time frame: post-op days 7, 14, 21, 28, 35, 42
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