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Electromagnetic Therapy
Pulsed Shortwave Treatment 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
Adult patients of at least 18 years of age undergoing cholecystectomy
Adult patients of at least 18 years of age undergoing primary knee arthroplasty
Must not have
Neuro-muscular deficit of the surgical area/limb
A planned postoperative perineural local anesthetic infusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative (within the operating room)
Awards & highlights
Summary
This trial is testing a new device that uses electromagnetic energy to help reduce pain after surgery. It targets adults who usually have significant pain after surgery. The device works by sending out energy waves that reduce pain and help the body heal.
Who is the study for?
This trial is for adults over 18 who are having knee or hip replacement surgery, or gallbladder removal. It's not for those with nerve problems in the surgical area, using a pacemaker, pregnant, in jail, or regularly taking opioids/tramadol recently.
What is being tested?
The study tests if pulsed shortwave therapy can help manage pain after surgery. Participants will receive either the active treatment or a sham (fake) version to compare effectiveness without opioid limitations.
What are the potential side effects?
Pulsed shortwave therapy is generally considered safe but may cause mild skin irritation at the application site. Unlike opioids, it doesn't have systemic side effects like drowsiness or addiction risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and scheduled for gallbladder removal surgery.
Select...
I am 18 or older and am having my first knee replacement surgery.
Select...
I am 18 or older and getting my first hip replacement.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have muscle or nerve problems in the area where I had surgery.
Select...
I am scheduled for pain relief medication to be infused near my nerves after surgery.
Select...
I have been using opioids or tramadol daily for more than 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain measured with the Numeric Rating Scale
Secondary study objectives
AVERAGE pain measured with the Numeric Rating Scale
Awakenings due to pain
Brief pain Inventory, short form (interference subscale)
+13 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Pulsed Shortwave Treatment with SofPulseActive Control1 Intervention
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Group II: Sham TreatmentPlacebo Group1 Intervention
Application of 8 days of sham device
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pulsed Shortwave (Radiofrequency) Therapy works by applying electromagnetic energy to the affected area, which helps control pain, reduce inflammation, and promote healing. This therapy is non-invasive and can decrease the need for opioids, which have significant side effects and addiction potential.
Similarly, electroanalgesia uses electrical currents to block pain signals and stimulate the release of endorphins, the body's natural painkillers. Laser therapy uses specific wavelengths of light to penetrate tissues, reducing pain and inflammation while promoting cellular repair.
These mechanisms are crucial for postoperative pain patients as they offer effective pain relief, reduce inflammation, and enhance healing without the risks associated with opioid use.
Use of electroanalgesia and laser therapies as alternatives to opioids for acute and chronic pain management.
Use of electroanalgesia and laser therapies as alternatives to opioids for acute and chronic pain management.
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,164 Previous Clinical Trials
1,571,111 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 have muscle or nerve problems in the area where I had surgery.I am 18 or older and scheduled for gallbladder removal surgery.I am 18 or older and am having my first knee replacement surgery.I am 18 or older and getting my first hip replacement.I am scheduled for pain relief medication to be infused near my nerves after surgery.You have a device implanted in your body that sends electrical pulses, like a cardiac pacemaker.Currently in jail or prison.I have been using opioids or tramadol daily for more than 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Active Pulsed Shortwave Treatment with SofPulse
- 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.
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