Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain
NCT ID: NCT01415856
Last Updated: 2011-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2010-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pulsed Electromagnetic Field Therapy for Neuropathic Pain in Lumbar Disc Herniation
NCT07263737
High Intensity Focused Electromagnetic Therapy on Pain and Quality of Life in Patients With Lumbar Disc Prolapse
NCT07278596
Effect of Pulsed Electromagnetic Stimulation on DOMS
NCT05554874
RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury
NCT03774823
Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Subacromial Impingement Syndrome
NCT05057871
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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 Device (Torino II)
Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.
Active Device (Torino II)
Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Weight: less than 300 lbs.
* Diagnosis: osteoarthritis
* Type of Surgery: unilateral knee replacement
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center for Joint Surgery and Sports Medicine, Maryland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Center for Joint Surgery and Sports Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Joint Surgery and Sports Medicine
Hagerstown, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ralph T Salvagno, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Salvagno 20100977
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.