What side effects are associated with this type of intervention?

Common treatments for postoperative pain similar to Pulsed Electromagnetic Field Therapy, such as nonthermal, pulsed shortwave radiofrequency therapies, generally have minimal side effects. These treatments are noninvasive and typically well-tolerated. However, some patients may experience mild skin irritation or discomfort at the application site. Unlike pharmacological treatments, these therapies do not carry risks of systemic side effects such as gastrointestinal issues, sedation, or dependency. Overall, they offer a safer profile for managing postoperative pain, inflammation, and promoting healing.

What prior FDA approvals exist?

The FDA has approved various devices for the treatment of postoperative pain, including nonthermal, pulsed shortwave radiofrequency therapies like Pulsed Electromagnetic Field (PEMF) Therapy. These devices have been in clinical use for over 70 years and are designed to reduce pain, inflammation, and promote healing. They are now available in small, portable, and relatively inexpensive forms, making them practical for common use. These therapies offer an alternative to traditional pain management methods, potentially reducing the need for opioids and other pharmacologic treatments.

What other types of research exist?

Promising novel alternatives to Pulsed Electromagnetic Field Therapy for postoperative pain management include: 1) Topical nitroglycerin, which may improve tendon healing and reduce pain through collagen synthesis stimulation. 2) Ultrasound-guided percutaneous needle tenotomy, which involves fenestrating tendinotic tissue to promote healing. 3) Iontophoresis, particularly with dexamethasone, which has shown short-term pain relief benefits. 4) Photobiomodulation therapy using NIR laser, which has demonstrated potential for immediate relief of chronic pain. These alternatives are under study and have shown varying degrees of efficacy in preliminary trials.

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Electromagnetic Field Therapy

Pulsed Electromagnetic Field Therapy for Postoperative Pain

N/A

Waitlist Available

Led By Brian M Ilfeld, MD, MS

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

Must not have

A planned postoperative perineural local anesthetic infusion

Neuro-muscular deficit of the surgical area/limb

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative day 180

Summary

This trial is testing a device that uses electromagnetic waves to help reduce pain and promote healing after surgery. It targets adults who have significant pain after surgery and aims to provide an alternative to opioid painkillers. The device works by emitting waves that interact with the body's cells to ease pain and speed up recovery.

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.

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.

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 below

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 7 (Measured in Oral Oxycodone Equivalents)

Secondary study objectives

AVERAGE Pain Measured With the Numeric Rating Scale

Awakenings Due to Pain

Brief Pain Inventory, Short Form (Interference Subscale)

+12 more

Trial 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.

0 / 13Eligibility 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 Electromagnetic Field (PEMF) Therapy, Transcutaneous Electrical Nerve Stimulation (TENS), and ultrasound therapy are nonpharmacologic treatments used for postoperative pain management. PEMF Therapy involves the application of nonthermal, pulsed, shortwave radiofrequency energy to reduce pain, inflammation, and promote healing by enhancing cellular repair processes and improving blood flow. TENS works by delivering electrical impulses through the skin to stimulate nerves, which can block pain signals and release endorphins, the body's natural painkillers. Ultrasound therapy uses sound waves to generate deep tissue heating, which can reduce pain and inflammation and promote tissue healing. These therapies are significant for postoperative pain patients as they offer pain relief without the side effects associated with opioids, reduce inflammation, and support faster recovery.

Use of electroanalgesia and laser therapies as alternatives to opioids for acute and chronic pain management.Pulsed radiofrequency: a critical review of its efficacy.