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

119 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for postoperative pain?

Research shows that pulsed electromagnetic fields can help reduce pain and improve healing after surgeries like breast reduction, Cesarean sections, and knee arthroplasty. These studies suggest that this treatment might be effective in managing postoperative pain. ^{1 2 3 4 5}

Is pulsed electromagnetic field therapy safe for humans?

Pulsed electromagnetic field therapy has been used in various studies for pain management and wound healing, showing no significant side effects or adverse events, suggesting it is generally safe for humans. ^{1 2 3 4 6}

How does Active Pulsed Shortwave Treatment with BioElectronics Model 088 differ from other treatments for postoperative pain?

This treatment uses pulsed electromagnetic fields (PEMF) to reduce postoperative pain, which is different from traditional pain management methods like medications. PEMF therapy is non-invasive and works by influencing the body's natural healing processes, potentially reducing the need for painkillers and speeding up recovery. ^{1 2 3 4 7}

Research Team

Brian M Ilfeld, MD, MS

Principal Investigator

University of California, San Diego

Eligibility Criteria

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 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Pulsed Electromagnetic Fields for Postsurgical Pain Management in Women Undergoing Cesarean Section: A Randomized, Double-Blind, Placebo-controlled Trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Pulsed electromagnetic fields for post-appendicectomy pain management: a randomized, placebo-controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Use of a pulsed electromagnetic field for treatment of post-operative pain in dogs: a pilot study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pulsed electromagnetic fields improve pain management and clinical outcomes after medial unicompartmental knee arthroplasty: A prospective randomised controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Treating Intractable Postamputation Pain with Noninvasive, Wearable, Nonthermal, Pulsed Shortwave (Radiofrequency) Therapy: A 12-Patient Case Series. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Exposure to a specific pulsed low-frequency magnetic field: a double-blind placebo-controlled study of effects on pain ratings in rheumatoid arthritis and fibromyalgia patients. [2022]