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Electromagnetic Field Therapy
Pulsed Electromagnetic Field Therapy for Postoperative Pain
N/A
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing inguinal hernia repair
Patients undergoing percutaneous nephrolithotomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative (within the operating room)
Awards & highlights
Study Summary
This trial is looking at the effects of a new pain control method that uses electromagnetic energy. The new devices are small, portable, and don't produce electromagnetic interference. The study is to see if this new method can help with acute postoperative pain and to optimize the study protocol.
Who is the study for?
This trial is for adults over 18 who are having certain surgeries like laparoscopic sleeve gastrectomy, hernia repairs, joint replacements, and more. They should expect moderate pain post-surgery but can't join if they're pregnant, use opioids daily, have a pacemaker-like device implanted, are incarcerated or have nerve/muscle issues in the surgery area.Check my eligibility
What is being tested?
The study tests pulsed electromagnetic field therapy using a portable BioElectronics device to manage postoperative pain. Participants will be randomly assigned to receive either the active treatment or a sham (fake) treatment without knowing which one they get.See study design
What are the potential side effects?
Since this therapy uses nonthermal pulsed shortwave energy instead of drugs, it may not have typical drug side effects. However, potential side effects aren't detailed here and would be monitored during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery for an inguinal hernia.
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I am having surgery to remove kidney stones.
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I am having surgery on my hand, forearm, or elbow and expect moderate pain.
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I am having knee or hip replacement surgery.
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I am having surgery on my shoulder that does not involve fixing the rotator cuff.
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I am scheduled for or have had a laparoscopic gallbladder removal.
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I am 18 or older and scheduled for a specific surgery.
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I am having foot/ankle surgery and expect moderate to severe pain.
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I am having spinal surgery and expect to have moderate pain.
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I am having breast surgery that is not a mastectomy and will receive a one-time nerve block.
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I am having a laparoscopic sleeve gastrectomy.
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I am having surgery to repair a hernia in my abdomen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one single measure recorded on or following the day of surgery (whichever day patient is discharged)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one single measure recorded on or following the day of surgery (whichever day patient is discharged)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total OPIOID consumption from recovery room discharge until the data collection phone call on postoperative day 7 (measured in oral oxycodone equivalents)
Secondary outcome measures
AVERAGE pain measured with the Numeric Rating Scale
Pain
Pain
+12 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Pulsed Shortwave Treatment with BioElectronics Model 088Active Control1 Intervention
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Group II: Sham TreatmentPlacebo Group1 Intervention
Application of 7-30 days of a nonfunctional sham device.
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,114 Previous Clinical Trials
1,519,760 Total Patients Enrolled
6 Trials studying Postoperative Pain
401 Patients Enrolled for Postoperative Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery for an inguinal hernia.I am having surgery to remove kidney stones.I am having surgery on my hand, forearm, or elbow and expect moderate pain.I am having knee or hip replacement surgery.I am having surgery on my shoulder that does not involve fixing the rotator cuff.You have a device implanted in your body that sends electrical pulses, like a pacemaker.I am scheduled for or have had a laparoscopic gallbladder removal.I have been using opioids or tramadol daily for more than 4 weeks.I am scheduled for pain relief medication to be infused near my nerves after surgery.I am 18 or older and scheduled for a specific surgery.I am having foot/ankle surgery and expect moderate to severe pain.I have muscle or nerve problems in the area where I had surgery.I am having spinal surgery and expect to have moderate pain.I am having breast surgery that is not a mastectomy and will receive a one-time nerve block.I am having a laparoscopic sleeve gastrectomy.I am having surgery to repair a hernia in my abdomen.You are currently in prison.
Research Study Groups:
This trial has the following groups:- Group 1: Active Pulsed Shortwave Treatment with BioElectronics Model 088
- Group 2: Sham Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this clinical trial at present?
"The trial indicated on clinicaltrials.gov is not currently recruiting patients, having first been posted on July 18th 2022 and most recently edited August 25th 2022. Nevertheless, there are 590 other research projects in need of participants at this time."
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