Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01415856
• Other study ID #: Salvagno 20100977
• Status: Recruiting
• Phase: Phase 2
• First received: August 10, 2011
• Last updated: August 11, 2011
• Start date: October 2010

Study information

• Verified date: August 2011
• Source: Center for Joint Surgery and Sports Medicine, Maryland
• Contact: Ralph T Salvagno, MD
• Phone: 301-665-4575
• Email: ralphs[@]hipknee.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Active Device (Torino II)
Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.
• Sham Device (Torino II)
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.

Locations

Country	Name	City	State
United States	Center for Joint Surgery and Sports Medicine	Hagerstown	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Center for Joint Surgery and Sports Medicine, Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Narcotic Pain Medications	Patients will record their use of pain and anti-inflammatory medications.	2 weeks	No
Secondary	Range of Motion	Patient range of motion in degrees will be measured, for flexion and extension.	2 weeks	No