Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery

Launched by STANFORD UNIVERSITY · Sep 27, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Pulsed Electromagnetic Field (PEMF) therapy to see if it can help reduce pain after orthopedic surgery on the knee or shoulder. The main goal is to find out if patients experience less pain 10 days after their surgery when they use PEMF therapy. Researchers will also look at how much pain medication patients need and how well they can move around after treatment.

To participate in the trial, you need to be at least 18 years old and scheduled for knee or shoulder surgery. You should not have taken certain pain medications (like NSAIDs) for a week before surgery and must be willing to do physical therapy exercises afterward. However, some people may not be eligible, including those with specific health conditions like certain autoimmune diseases or diabetes. If you join the study, you'll receive PEMF therapy and complete surveys about your pain and recovery. This could be a great opportunity to explore a potential new way to manage post-surgery pain!

Gender

ALL

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.