PEMF Therapy for Postoperative Pain After Orthopedic Surgery

Overseen By Michelle Xiao, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Corticosteroids, Antineoplastics, Immunosuppressives, others

Disqualifiers: Diabetes, HIV, Hepatitis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether pulsed electromagnetic field (PEMF) therapy can reduce pain after shoulder or knee surgery. Participants will receive either an active PEMF device or a placebo (inactive) device post-surgery to determine if the treatment eases pain and reduces the need for pain medication. Individuals undergoing shoulder or knee surgery who have not taken NSAIDs (nonsteroidal anti-inflammatory drugs) for a week before surgery might be suitable candidates. The trial aims to assess the effectiveness of PEMF therapy in improving recovery and reducing pain. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-surgical recovery.

Will I have to stop taking my current medications?

The trial requires that you stop taking NSAIDs (non-steroidal anti-inflammatory drugs) for one week before surgery, but low-dose aspirin is allowed. If you are taking corticosteroids, antineoplastic, immunostimulation, or immunosuppressive agents, you must stop them 30 days before surgery, except for asthma and eye medications.

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

Research shows that the Endonovo SofPulse device, which uses pulsed electromagnetic field (PEMF) therapy, is generally easy for patients to handle. Studies have demonstrated that this technology is FDA-cleared, indicating it has met safety standards for treating acute pain. Past trials found that PEMF therapy significantly speeds up healing and reduces the need for pain medications, without major side effects.

Although detailed information on side effects isn't provided, FDA clearance for other uses suggests it is considered safe. This is reassuring for those considering participation in a trial with this treatment. Remember, all medical treatments can affect people differently, so discussing any concerns with a healthcare professional is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional pain management options for postoperative pain, which often rely on medications like opioids or NSAIDs, Endonovo SofPulse uses a novel approach with pulsed electromagnetic field (PEMF) therapy. This non-invasive treatment is unique because it targets pain and inflammation directly at the cellular level, potentially reducing the need for pharmaceuticals and their associated side effects. Researchers are excited about SofPulse because it offers a drug-free alternative that could accelerate recovery and improve patient comfort without the risks of addiction or adverse reactions associated with conventional pain medications.

What evidence suggests that PEMF therapy is effective for reducing postoperative pain?

Research has shown that pulsed electromagnetic field (PEMF) therapy, such as Endonovo SofPulse, can reduce pain after surgeries. In this trial, participants will receive either the active Endonovo SofPulse device, which emits a pulsed electromagnetic field, or a placebo device that does not emit PEMF. Studies found that SofPulse significantly decreased post-surgery pain. Previous patients reported less pain and better recovery with PEMF therapy. This suggests that the Endonovo SofPulse device may ease pain after shoulder or knee surgeries. ^{1 3 6 7 8}

Who Is on the Research Team?

Geoffrey D Abrams, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having shoulder or knee surgery and can do post-op physical therapy. They must not have taken NSAIDs a week before surgery, be willing to sign consent, and not drink excessively. Excluded are those with HIV, hepatitis, severe mental illness, certain connective tissue diseases, diabetes, unknown pain causes, recent corticosteroid use (except asthma/eye meds), medical marijuana users, compensation/litigation seekers for musculoskeletal issues.

Inclusion Criteria

I am willing and able to do physical therapy after surgery.

Subject must understand and be willing to sign the IRB-approved Informed Consent Document.

I am scheduled for shoulder or knee surgery.

Exclusion Criteria

Subject is currently seeking or receiving worker's compensation for this injury or for an injury that has occurred more than 12 months prior to enrollment in this study or subjects who are currently in litigation or who have a history of litigation related to musculoskeletal diagnoses.

I do not use medical marijuana or CBD oils.

I have an autoimmune disease like rheumatoid arthritis or lupus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or placebo PEMF therapy post-operatively for 10 days

10 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Endonovo SofPulse

Trial Overview The study tests if PEMF therapy using Endonovo SofPulse reduces pain after orthopedic surgery on the shoulder or knee. It measures how much it lowers pain levels at day 10 post-surgery using a visual scale and checks medication usage and physical function outcomes.

How Is the Trial Designed?

Group I: Active PEMF Group Active Control 1 Intervention

Participants will have a 1 in 2 chance to get the active treatment device post-operatively. The device will be attached to the post-operative dressing. The device is an Endonovo SofPulse that emits a pulsed electromagnetic field (PEMF). Single blind randomization.

Group II: Placebo PEMF Group Placebo Group 1 Intervention

Participants will have a 1 in 2 chance to get the placebo treatment device post-operatively. The device will be attached to the post-operative dressing. The Endonovo SofPulse placebo device does not emit a pulsed electromagnetic field (PEMF). Single blind randomization.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Endonovo

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

Pulsed Electro Magnetic Fields (PEMFs) treatment has been shown to be safe and well-tolerated in patients undergoing joint replacement surgery, with no reported adverse effects and good patient compliance.

The use of PEMFs in the early days post-surgery can effectively control inflammation and improve functional recovery, suggesting it could be a beneficial addition to standard post-operative care for hip, knee, or shoulder arthroplasties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of pulsed electromagnetic fields after joint replacements. Lullini, G., Cammisa, E., Setti, S., et al.[2020]

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 pilot study involving 27 patients with osteoarthritis, those treated with pulsed electromagnetic fields (PEMF) showed an average improvement of 23-61% in clinical symptoms, compared to only 2-18% improvement in the placebo group.

No toxicity was observed in patients receiving PEMF treatment, indicating it is a safe option, and the results suggest that PEMF could be an effective method for alleviating symptoms of osteoarthritis, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind trial of the clinical effects of pulsed electromagnetic fields in osteoarthritis. Trock, DH., Bollet, AJ., Dyer, RH., et al.[2010]

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 study of 36 subjects with persistent pain after lumbar surgery, pulsed electromagnetic field (PEMF) therapy with a 42-μs pulse width significantly reduced low-back pain by 40.2% compared to a sham treatment, indicating its potential effectiveness for postoperative pain relief.

The 42-μs PEMF therapy also showed a notable reduction in leg pain by 45.0%, suggesting that this treatment may help alleviate both low-back and radiating leg pain following lumbar surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of pulsed electromagnetic field therapy for the treatment of chronic postoperative pain following lumbar surgery: a pilot, double-blind, randomized, sham-controlled clinical trial. Sorrell, RG., Muhlenfeld, J., Moffett, J., 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]

Pulsed electromagnetic field (PEMF) therapy has been shown to effectively manage postsurgical pain and edema, as well as promote healing in chronic wounds, making it a valuable tool in plastic surgery.

PEMF therapy is noninvasive and has no known side effects, providing a safe adjunctive treatment option for postoperative recovery, supported by scientific evidence of its mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery. Strauch, B., Herman, C., Dabb, R., et al.[2022]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04109638

Pulsed Electromagnetic Field (PEMF) Therapy for Post- ... The primary objective of this study is to prospectively determine, at 10 days after orthopedic shoulder or knee surgery, if pulsed electromagnetic field (PEMF) ...

2. withpower.com withpower.com/trial/phase-knee-injuries-1-2021-e8ca1

PEMF Therapy for Postoperative Pain After Orthopedic ... Research shows that pulsed electromagnetic field (PEMF) therapy, like Endonovo SofPulse, can help reduce pain and improve recovery after surgeries, such as ...

3. biospace.com biospace.com/endonovo-s-sofpulse-to-be-featured-at-innovative-pain-management-solutions

Endonovo's SofPulse® to Be Featured at Innovative Pain ... The results of the study demonstrate that the use of SofPulse® significantly decreased postoperative ... SofPulse® into its post-operative pain ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29950893/

Evaluation of pulsed electromagnetic field therapy for the ... Conclusion: PEMF therapy (42-μs pulse width) was associated with trends for a reduction in pain, compared to sham treatment. Secondary endpoints ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02211534

Pilot Study of PEMF Therapy in Treatment of Post-operative ... This is a multi-site randomized, double-blinded, parallel-group prospective pilot study of the analgesic effectiveness of twice-daily PEMF therapy in the ...

6. sofpulse.com sofpulse.com/

SofPulse FDA Cleared Medical Device... clinically proven to significantly speed the healing process and reduce the need for pain medications. Home · SofPulse.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/83/NCT05796583/Prot_SAP_000.pdf

Official Title: Pulsed Electromagnetic Fields for Postoperative More recently, small, simple, lightweight, battery-powered, noninvasive PEMF devices have received. FDA clearance for use treating acute and ...

8. synapse.patsnap.com synapse.patsnap.com/organization/4f2633078fd4d0a52250c6d25ca0cbd7

Endonovo Therapeutics, Inc. - Drug pipelines, Patents, ... A pilot prospective, randomized, placebo-controlled study to evaluate the efficacy of pulsed electromagnetic field (PEMF) therapy in decreasing post-operative ...