Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the Torino II device, which emits a pulsed electromagnetic field), will help to decrease pain and swelling after knee replacement surgery, and thereby decrease the use of narcotic medications after surgery.

Detailed Description
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The investigators are conducting a research study to determine if the Torino II, a pulsed electromagnetic fields (PEMF) device is helpful in reducing postoperative pain and swelling after total knee replacement surgery. Postoperative pain and swelling may cause discomfort that may directly influence functional recovery after surgery. By reducing pain and swelling immediately following surgery,the use of high doses of narcotic, NSAID, and Tyelenol pain killers can be reduced, and possibly avoided. Recovery can be maximized, as well. The PEMF device that is being used (the Torino II) is distributed by Ivivi Health Sciences, and has been approved by the FDA for the treatment of pain and swelling following surgery. The device is non-invasive, and is fixed onto the outside of the dressing with Velcro straps. The device will give off electromagnetic pulses to target pain relief in the knee. PEMF devices have been in clinical use for decades, and to date, no reported side effects have occurred. It is important to note that treatment will still follow the standard Meritus Medical Center protocol for knee replacement surgery. This includes pain medication, icing, and physical therapy. This standard protocol will be followed no matter what study group patients are assigned to. Participation in this study or lack thereof will not change the treatment protocol.

Official Title
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A Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Non-Invasive Pulsed Electromagnetic Fields (PEMF) on Postoperative Pain Following Total Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Active Device (Torino II)
* Device: Sham Device (Torino II)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: greater than 18 years Weight: less than 300 lbs. Diagnosis: osteoarthritis Type of Surgery: unilateral knee replacement Exclusion Criteria: No pacemaker or defibrillator. No infection of the affected knee. No previous open surgery of the affected knee. No history of Rheumatoid Arthritis. No more than 2 narcotic pills per month in the last 6 months for pain.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham Device (Torino II)<br>Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks. | Device: Sham Device (Torino II)<br>* Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks.<br>|
| Active Comparator: Active Device (Torino II)<br>Device is giving treatment for 15 minutes every 2 hours for a total of two weeks. | Device: Active Device (Torino II)<br>* Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain is measured on a scale of 0-10, which is the VAS scale used by most hospitals, including Meritus Medical Center. 0 indicates no pain, while 10 indicates the worst pain possible. | 2 weeks | 
| Edema (Swelling) | Swelling will be measured by using a disposable tape measure to measure the circumference of the patient's knee at the mid-patellar region. This will be measured in millimeters. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Pain Medications | Patients will record their use of pain and anti-inflammatory medications. | 2 weeks | 
| Range of Motion | Patient range of motion in degrees will be measured, for flexion and extension. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulsed electromagnetic fields device, Torino II, postoperative knee pain, knee replacement