Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2010 |
| Contact: | Ralph T Salvagno, MD |
| Email: | ralphs@hipknee.com |
| Phone: | 301-665-4575 |
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
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.
electromagnetic field), will help to decrease pain and swelling after knee replacement
surgery, and thereby decrease the use of narcotic medications after surgery.
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.
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.
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.
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