PEMF Therapy for Postoperative Pain After Orthopedic Surgery

Overseen by Geoffrey D Abrams, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

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

Disqualifiers: Diabetes, HIV, Hepatitis, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether PEMF therapy can help reduce pain in patients who have had shoulder or knee surgery. PEMF therapy uses electromagnetic waves to interact with the body's cells, which may reduce pain and speed up healing. The study will measure pain levels, medication use, and physical function after surgery. PEMF therapy has been evaluated as a therapeutic strategy for pain management in several clinical scenarios, showing positive efficacy and safety profiles.

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 data supports the effectiveness of the treatment Endonovo SofPulse for postoperative pain after orthopedic surgery?

Research shows that pulsed electromagnetic field (PEMF) therapy, like Endonovo SofPulse, can help reduce pain and improve recovery after surgeries, such as Cesarean sections and joint replacements, by reducing inflammation and promoting healing. ^{1 2 3 4 5}

Is PEMF therapy safe for humans?

PEMF therapy has been used in various studies for different conditions, including postoperative pain and osteoarthritis, and is generally considered safe for humans based on existing research. ^{1 2 6 7 8}

How does PEMF therapy differ from other treatments for postoperative pain after orthopedic surgery?

PEMF therapy is unique because it uses electromagnetic fields to reduce pain and inflammation, which is different from traditional pain management methods like medications. It is non-invasive and has shown potential benefits in various surgeries, including joint replacements, by promoting bone healing and reducing chronic pain without the side effects associated with drugs. ^{1 2 3 5 7}

Research Team

Geoffrey D Abrams, MD

Principal Investigator

Stanford University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Endonovo SofPulse (Electromagnetic Therapy)

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.

Participant Groups

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+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

Endonovo

Collaborator

Trials

1

Recruited

80+

Findings from Research

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 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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. New Zealand 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. [2022]

3. 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]

4. 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]

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

Role of pulsed electromagnetic fields after joint replacements. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

A double-blind trial of the clinical effects of pulsed electromagnetic fields in osteoarthritis. [2010]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery. [2022]