Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain

August 11, 2011 updated by: Center for Joint Surgery and Sports Medicine, Maryland

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Hagerstown, Maryland, United States, 21742
        • Recruiting
        • Center for Joint Surgery and Sports Medicine
        • Contact:
          • Ralph T Salvagno, MD
          • Phone Number: 301-665-4575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Device: 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.
Active Comparator: Active Device (Torino II)
Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.
Device: Active Device (Torino II)
Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Joint Surgery and Sports Medicine, Maryland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (Estimate)

August 12, 2011

Study Record Updates

Last Update Posted (Estimate)

August 12, 2011

Last Update Submitted That Met QC Criteria

August 11, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Salvagno 20100977

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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