Clinical trial NCT01415856: Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: pulsed electromagnetic fields device
Torino II
postoperative knee pain
knee replacement
Lead sponsor: Center for Joint Surgery and Sports Medicine, Maryland
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain
timeFrame: 2 weeks
measure: Edema (Swelling)
timeFrame: 2 weeks
Secondary outcomes:
measure: Narcotic Pain Medications
timeFrame: 2 weeks
measure: Range of Motion
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hagerstown
country: United States
facility: Center for Joint Surgery and Sports Medicine
state: Maryland
Study officials:
References: