What side effects are associated with this type of intervention?

Pulsed shortwave (radiofrequency) therapy, which uses electromagnetic energy to control pain, reduce inflammation, and promote healing, is generally well-tolerated with minimal side effects. Common side effects may include mild skin irritation or redness at the application site. In rare cases, patients might experience discomfort or a sensation of warmth during treatment. Compared to traditional pain management methods like opioids, which can cause nausea, constipation, dependency, and respiratory depression, pulsed shortwave therapy offers a safer profile with fewer systemic side effects.

What prior FDA approvals exist?

The FDA has approved various devices for the treatment of postoperative pain that utilize electromagnetic energy. These include pulsed shortwave therapy devices, which have been in clinical use for over 70 years. These devices are designed to control pain, reduce inflammation, and promote healing. Modern versions are small, lightweight, and noninvasive, making them practical for common use. They function for up to 8 days and are intended to improve analgesia while potentially reducing the need for opioids.

What other types of research exist?

Promising novel alternatives to Pulsed Shortwave Therapy for postoperative pain management include: 1) Transcutaneous Supraorbital Nerve Stimulation, which has shown significant reduction in migraine days and no adverse events in trials; 2) Transcranial Magnetic Stimulation, which has demonstrated effectiveness in reducing headache days and functional disability with minimal side effects; and 3) Biofeedback-assisted relaxation, which has been effective in reducing cancer-related pain in small trials. These alternatives offer non-invasive options with potential benefits for pain control and healing.

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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 below

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I am 18 or older and scheduled for gallbladder removal surgery.

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I am 18 or older and am having my first knee replacement surgery.

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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:

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I have muscle or nerve problems in the area where I had surgery.

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I am scheduled for pain relief medication to be infused near my nerves after surgery.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7 for reporting.

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 more

Trial 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

0 / 6Eligibility criteria met

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.