What side effects are associated with this type of intervention?

Common treatments for shoulder injuries, such as Pulsed Electromagnetic Field (PEMF) Therapy, ultrasound therapy, laser therapy, and shortwave diathermy, generally have minimal side effects. PEMF therapy is well-tolerated with rare reports of mild discomfort or skin irritation at the treatment site. Ultrasound therapy may cause mild warmth or discomfort, and in rare cases, burns if improperly used. Laser therapy can occasionally lead to temporary pain or redness. Shortwave diathermy might cause skin burns or discomfort due to deep tissue heating. Overall, these treatments are considered safe with proper application.

What prior FDA approvals exist?

The FDA has approved various treatments for shoulder injuries, including non-invasive therapies like Pulsed Electromagnetic Field (PEMF) Therapy, which is used to reduce pain and inflammation. PEMF therapy has been studied for its benefits in post-operative pain management following orthopedic surgeries, including shoulder procedures. While specific FDA approvals for PEMF in shoulder injuries may not be detailed, the therapy is recognized for its potential to enhance recovery by promoting tissue repair and reducing inflammation. Other related FDA-approved treatments for shoulder injuries include physical therapy modalities, corticosteroid injections, and surgical interventions when necessary.

What other types of research exist?

Promising alternatives to PEMF therapy for shoulder injuries include: 1) Platelet-Rich Plasma (PRP) Injections: PRP contains growth factors that may promote tissue repair and reduce inflammation. 2) Manual Therapy: Techniques such as massage and manual lymph drainage have shown benefits in reducing pain and improving function. 3) Acupuncture: This traditional therapy has been effective in managing pain and inflammation in various musculoskeletal conditions. 4) Low-Level Laser Therapy (LLLT): This therapy uses light to reduce pain and inflammation and promote healing. These alternatives should be discussed with a healthcare provider to determine the best treatment plan.

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PEMF Therapy for Postoperative Pain After Orthopedic Surgery

N/A

Recruiting

Led By Geoffrey D Abrams, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

The information provided does not specify side effects of PEMF therapy; however generally PEMF is considered non-invasive with minimal risks which may include mild discomfort or none at all.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change from baseline in pain scores on the visual analog scale (VAS) at 10 days

Secondary study objectives

Mean change from baseline in narcotic pain medicine use at 10 days

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active PEMF GroupActive Control1 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 GroupPlacebo Group1 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.

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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 uses electromagnetic fields to reduce pain and inflammation by promoting cellular repair and improving blood flow, which can accelerate healing in shoulder injuries. Physical therapy, including exercises and manual techniques, helps restore mobility and strength by targeting the muscles and tendons around the shoulder. Nonsteroidal anti-inflammatory drugs (NSAIDs) reduce inflammation and pain by inhibiting enzymes involved in the inflammatory process. Corticosteroid injections provide potent anti-inflammatory effects, offering relief from severe pain and swelling. These treatments are crucial for shoulder injury patients as they address pain, inflammation, and functional impairments, facilitating a quicker and more effective recovery.