- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01415856
Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain
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 Overview
Status
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Ralph T Salvagno, MD
- Phone Number: 301-665-4575
- Email: ralphs@hipknee.com
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 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 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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