Using pulsed electromagnetic field therapy to reduce post-operative pain after orthopedic surgery

A Pilot Prospective, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Pulsed Electromagnetic Field (PEMF) Therapy in Decreasing Post-Operative Pain Following Orthopedic Surgery

This study is testing if pulsed electromagnetic field therapy can help reduce pain after shoulder or knee surgery for adults.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (other)
• Locations: 1 site (Redwood City, California)
• Trial ID: NCT04109638 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of pulsed electromagnetic field (PEMF) therapy in alleviating post-operative pain in patients undergoing shoulder or knee surgery. Participants will be assessed 10 days post-surgery using a visual analog scale (VAS) to measure pain levels, alongside tracking their daily pain medication intake and physical function outcomes. The intervention involves the use of the Endonovo SofPulse device, which delivers PEMF therapy to the affected areas. The study will include both male and female patients aged 18 and older who meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older scheduled for shoulder or knee surgery who have not used NSAIDs in the week prior to surgery.

Not a fit: Patients with known collagen disorders, inflammatory or autoimmune diseases, or metabolic bone diseases may not benefit from this therapy.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce post-operative pain and improve recovery outcomes for patients undergoing orthopedic surgery.

How similar studies have performed: While PEMF therapy has been explored in various contexts, this specific application for post-operative orthopedic pain is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Subjects may be male or female greater or equal to 18 years of age (≥ 18) at the time of consent.
2. Subjects who will be having shoulder or knee surgery are permitted.
3. Subject must not have used NSAIDs for one (1) week prior to surgery.

   a. a. Low-dose aspirin (81 mg) is permitted.
4. Subject must be willing and able to participate in post-operative physical therapy exercises.
5. Subject must understand and be willing to sign the IRB-approved Informed Consent Document.

Exclusion Criteria:

1. Subject has a known collagen disorder such as, but not limited to, osteogenesis imperfecta (OI) or Ehlers-Danlos syndrome (EDS).
2. Subject has a known inflammatory or autoimmune connective tissue disease such as, but not limited to, gout affecting the shoulder, scleroderma, SLE, rheumatoid disease, or calcific tendonitis of the shoulder.
3. Subject has a metabolic bone disease such as Paget's disease or osteomalacia as documented in the medical record.
4. Subject has a deltoid defect, deltoid palsy or any other pseudoparalysis.
5. Subject is diabetic.
6. Subject has HIV or hepatitis.
7. Subject has a diagnosis of fibromyalgia or other chronic pain syndrome.
8. Subject has shoulder or knee pain of unknown etiology.
9. Subject has had an active malignancy in the past 5 years OR has an active or on-going neoplastic disease, except for benign skin cancer(s).
10. Subject has undergone administration, within 30 days prior to surgery, of any type of corticosteroid (with the exception of asthma medications and ophthalmic medications), antineoplastic, immunostimulation or immunosuppressive agent.
11. Subject is septic, or has a local or systemic infection.
12. Subject has an admitted active substance abuse problem which includes recreational drugs and/or narcotics or a history of substance abuse where history is defined as "not under the care of a physician" for more than 5 years.

    a. Prescriptive medical marijuana is not permitted, including CBD oils.
13. Subject consumes more than 14 (men) or 7 (women) standard drinks (alcoholic units) per week where a drink equals a 12 oz. beer, or a 5 oz. glass of wine, or a 1.5 oz. shot of liquor.
14. 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.
15. Subject has major mental illnesses including major depression, bipolar disorder, schizophrenia or dementia that would prevent them from following the protocol and/or independently completing the patient reported outcomes measures.
16. Subjects who have coexistent cervical spinal pathologies such as radiculopathies or myelopathies.
17. Subject has a mental or physical condition that would prevent them from complying with the study protocol.

Where this trial is running

Redwood City, California

• Stanford University — Redwood City, California, United States (RECRUITING)

Study contacts

• Principal investigator: Geoffrey D Abrams, MD — Stanford University
• Study coordinator: Michelle Xiao, BS

Conditions: Knee Injuries, Shoulder Injuries, Pain, Postoperative, PEMF