Pulsed Electromagnetic Field Therapy for Postoperative Pain

Overseen By Baharin Abdullah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Opioids, Tramadol

Disqualifiers: Pacemaker, Pregnancy, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 29

Duration: 7-30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing post-surgery pain using pulsed electromagnetic field therapy. A small, portable device emits electromagnetic energy to help reduce pain and inflammation, potentially decreasing the need for painkillers like opioids. Participants will receive either the active treatment (Active Pulsed Shortwave Treatment with BioElectronics Model 088) or a sham (inactive) treatment to assess the therapy's effectiveness. This trial suits individuals undergoing specific surgeries, such as knee replacements or spinal surgery, who expect to experience moderate pain afterward. As an unphased trial, it offers participants the chance to explore innovative pain management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you use opioids or tramadol daily, you may not be eligible to participate.

What prior data suggests that this method is safe for postoperative pain management?

Research has shown that pulsed electromagnetic field therapy is very safe. Studies have found it does not cause widespread side effects or major problems. The FDA has approved these devices for many years, ensuring they are safe and noninvasive. In past studies, patients using this therapy reported no serious issues, indicating that most people tolerate the treatment well. Overall, it appears to be a safe choice for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pulsed electromagnetic field therapy for postoperative pain because it offers a noninvasive, drug-free alternative to traditional pain management methods like opioids and NSAIDs. This therapy uses nonthermal, pulsed shortwave radiofrequency, which is believed to help reduce inflammation and pain without the side effects associated with medications. Moreover, this approach can be applied consistently over 7-30 days, potentially speeding up recovery and improving patient outcomes.

What evidence suggests that pulsed electromagnetic field therapy is effective for postoperative pain?

Research has shown that pulsed electromagnetic field therapy, which participants in this trial may receive as the Active Pulsed Shortwave Treatment with BioElectronics Model 088, can help reduce pain after surgery. One study found it lowered pain by 57% just one hour after surgery and by 300% at five hours. This pain relief also led to a 2.2 times decrease in the need for opioid painkillers. However, other studies have reported mixed results, with some not finding a significant drop in pain or opioid use. Despite these mixed findings, the therapy remains a promising noninvasive option for managing pain after surgery. Participants in this trial may also receive a Sham Treatment as a comparator. ^{1 2 3 5 6}

Who Is on the Research Team?

Brian M Ilfeld, MD, MS

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am having surgery to remove kidney stones.

I am having surgery for an inguinal hernia.

I am having surgery on my hand, forearm, or elbow and expect moderate pain.

Exclusion Criteria

You have a device implanted in your body that sends electrical pulses, like a pacemaker.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either active or sham pulsed shortwave therapy for postoperative pain management

7-30 days

Participants are monitored via phone calls on postoperative days 1, 2, 3, and 7

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain and opioid consumption

28 days

Follow-up phone contact on postoperative day 28

Long-term Follow-up

Participants' pain levels and opioid consumption are assessed at 180 days postoperatively

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Active Pulsed Shortwave Treatment with BioElectronics Model 088
• Sham Treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: Active Pulsed Shortwave Treatment with BioElectronics Model 088 Active Control 1 Intervention

Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088

Group II: Sham Treatment Placebo Group 1 Intervention

Application of 7-30 days of a nonfunctional sham device.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

In a study of 72 women undergoing elective C-sections, those receiving pulsed electromagnetic field (PEMF) treatment reported significantly lower postoperative pain levels and required 1.9 times fewer analgesics in the first 24 hours compared to the placebo group.

Patients treated with PEMF also showed improved wound healing by the seventh postoperative day, with fewer signs of complications such as exudate, erythema, or edema, indicating its potential as an effective adjunct therapy for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed Electromagnetic Fields for Postsurgical Pain Management in Women Undergoing Cesarean Section: A Randomized, Double-Blind, Placebo-controlled Trial. Khooshideh, M., Latifi Rostami, SS., Sheikh, M., et al.[2018]

Pulsed electromagnetic field therapy significantly reduced postoperative pain by 57% at 1 hour and 300% at 5 hours after surgery, leading to a 2.2-fold decrease in narcotic use among patients.

The therapy also lowered levels of IL-1 beta in wound exudates by 275%, suggesting a mechanism involving nitric oxide signaling that may enhance wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients. Rohde, C., Chiang, A., Adipoju, O., et al.[2021]

In a double-blinded, randomized trial involving 118 post-appendicectomy patients, pulsed electromagnetic field (PEMF) therapy did not significantly reduce postoperative pain or the use of intravenous fentanyl compared to a placebo device over the first 12 hours after surgery.

Both pain scores and fentanyl usage declined similarly in both the active-PEMF and inactive control groups, indicating that PEMF is not an effective adjunct for pain management in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed electromagnetic fields for post-appendicectomy pain management: a randomized, placebo-controlled trial. Perumal, M., Abdul Latib, AI., Samy, MP., et al.[2022]

In a study involving 16 healthy dogs undergoing ovariohysterectomy, pulsed electromagnetic field (PEMF) therapy showed potential to reduce post-operative pain when combined with morphine, as indicated by lower pain scores in the magnet/morphine group compared to the control group.

While the results did not show a clear overall benefit of PEMF alone, the findings suggest that PEMF may enhance the effectiveness of morphine analgesia, warranting further investigation into its analgesic properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a pulsed electromagnetic field for treatment of post-operative pain in dogs: a pilot study. Shafford, HL., Hellyer, PW., Crump, KT., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11744435/

Wearable, noninvasive, pulsed shortwave (radiofrequency ... Conclusions. Pulsed shortwave (radiofrequency) therapy did not reduce pain scores and opioid requirements to a statistically significant or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05399355?term=AREA%5BBasicSearch%5D(pulsed%20electromagnetic%20fields)&rank=10

Pulsed Electromagnetic Fields for Postoperative Analgesia ... The purpose of this pilot study is to explore the possibility of treating acute postoperative pain with nonthermal, pulsed shortwave (radiofrequency) therapy, ...

3. clinicalpainadvisor.com clinicalpainadvisor.com/reports/pulsed-shortwave-therapy-did-not-reduce-pain-scores-or-opioid-consumption-after-surgery/

Pulsed Shortwave Therapy Did Not Reduce Pain Scores or ... Pulsed shortwave therapy (PSWT) had no statistically significant effect on pain level or opioid consumption when administered soon after surgery.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000212

Pulsed Shortwave (Radiofrequency) Therapy With a ... Primary Outcome​​ During the first seven postoperative days, the sum of the daily pain intensity scores in the active group was a mean (SD) of 28 (11) vs 34 (14) ...

5. withpower.com withpower.com/trial/phase-postoperative-pain-acute-5-2022-db74c

Pulsed Electromagnetic Field Therapy for Postoperative Pain Pulsed electromagnetic field therapy significantly reduced postoperative pain by 57% at 1 hour and 300% at 5 hours after surgery, leading to a 2.2-fold decrease ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39829429/

A randomized, double-masked, sham-controlled pilot study Pulsed shortwave (radiofrequency) therapy did not reduce pain scores and opioid requirements to a statistically significant or clinically relevant degree.