Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Center for Joint Surgery and Sports Medicine, Maryland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Center for Joint Surgery and Sports Medicine, Maryland
ClinicalTrials.gov Identifier:
NCT01415856
First received: August 10, 2011
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Device: Active Device (Torino II)
Device: Sham Device (Torino II)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Center for Joint Surgery and Sports Medicine, Maryland:

Primary Outcome Measures:
  • Pain [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Edema (Swelling) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Narcotic Pain Medications [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Patients will record their use of pain and anti-inflammatory medications.

  • Range of Motion [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Patient range of motion in degrees will be measured, for flexion and extension.


Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415856

Contacts
Contact: Ralph T Salvagno, MD 301-665-4575 ralphs@hipknee.com

Locations
United States, Maryland
Center for Joint Surgery and Sports Medicine Recruiting
Hagerstown, Maryland, United States, 21742
Contact: Ralph T Salvagno, MD    301-665-4575      
Sponsors and Collaborators
Center for Joint Surgery and Sports Medicine, Maryland
  More Information

No publications provided

Responsible Party: Ralph T. Salvagno, MD, Center for Joint Surgery and Sports Medicine
ClinicalTrials.gov Identifier: NCT01415856     History of Changes
Other Study ID Numbers: Salvagno 20100977
Study First Received: August 10, 2011
Last Updated: August 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Center for Joint Surgery and Sports Medicine, Maryland:
pulsed electromagnetic fields device
Torino II
postoperative knee pain
knee replacement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014