Anterior Cruciate Ligament
Conditions
Keywords
electrical stimulation, pain, medication, edema, interferential, neuromuscular, high voltage pulsed current, knee
Brief summary
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.
Interventions
DEVICESurgiStim3
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.
Sponsors
VQ OrthoCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Agree to provide informed consent to be included within this ACL study * Demonstrate a continued willingness to be compliant with the parameters established under the study; * Have no history of drug or alcohol abuse in the last 2 years; * Be either a male or female adult between the ages of 18 and 64; * Be undergoing a surgical repair of the anterior cruciate ligament (ACL) using either a hamstring, patella tendon, Achilles tendon, or allograft procedure; and * Understand that there is no financial remuneration for participation in the study.
Exclusion criteria
* Pregnant women * Insulin dependent diabetic patients * Patients with a demand type pacemaker * Patients who have a malignant tumor (other than basal cell epithelioma) * Patients with a known history of alcohol or drug abuse in the last 2 years * Patients who will not agree to provide informed consent to be included within this ACL study * Patients who demonstrate a continued unwillingness to be compliant with the parameters established under this study. * Poor healers as identified by the patient's medical history * Patients who have a history of sensitivity to surgical tape, electrode adhesives, etc. * Patients with a known history of RSD (reflex sympathetic dystrophy) * Patients with a history of chronic pain (on opiates or high dosage of NSAIDS for 3 months or greater) * Patients who have previously undergone an ACL reconstruction on the same knee * Patients with clinically varicose veins (clinically significant or symptomatic) * Patients whose history shows an abuse of diuretics or anti-inflammatory medications * Patients who will undergo multiple ligament surgery (i.e., ACL plus PCL, MCL, and/or LCL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain | post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42 |
Secondary
| Measure | Time frame |
|---|---|
| pain medications | post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42 |
| edema | post-op days 7, 14, 21, 28, 35, 42 |
Countries
United States
Outcome results
None listed