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Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery
Trial ID: NCT04109638
The primary objective of this study is to prospectively determine, at 10 days after orthopedic shoulder or knee surgery, if pulsed electromagnetic field (PEMF) therapy is beneficial in reducing patient-reported post-operative pain, as measured by visual analog scale (VAS). The amount of pain medication taken daily and the physical function outcome scores after surgery and PEMF treatment will also be measured.
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
1. Subjects may be male or female greater or equal to 18 years of age (≥ 18) at the time
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
5. Subject must understand and be willing to sign the IRB-approved Informed Consent
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
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
17. Subject has a mental or physical condition that would prevent them from complying with
the study protocol.
device: Endonovo SofPulse