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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedAugust 12, 2011
August 1, 2011
1.6 years
August 10, 2011
August 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (2)
Narcotic Pain Medications
2 weeks
Range of Motion
2 weeks
Study Arms (2)
Sham Device (Torino II)
PLACEBO COMPARATORDevice 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 Device (Torino II)
ACTIVE COMPARATORDevice is giving treatment for 15 minutes every 2 hours for a total of two weeks.
Interventions
Device is giving treatment for 15 minutes every 2 hours for a total 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.
Eligibility Criteria
You may qualify if:
- Age: greater than 18 years
- Weight: less than 300 lbs.
- Diagnosis: osteoarthritis
- Type of Surgery: unilateral knee replacement
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Joint Surgery and Sports Medicine
Hagerstown, Maryland, 21742, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 12, 2011
Study Start
October 1, 2010
Primary Completion
May 1, 2012
Last Updated
August 12, 2011
Record last verified: 2011-08