NCT04109638 Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery
| NCT ID | NCT04109638 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Knee Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2021-02-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Geoffrey D Abrams, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT04109638 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04109638 currently recruiting?
Yes, NCT04109638 is actively recruiting participants. Contact the research team at mxiao@stanford.edu for enrollment information.
Where is the NCT04109638 trial being conducted?
This trial is being conducted at Redwood City, United States.
Who is sponsoring the NCT04109638 clinical trial?
NCT04109638 is sponsored by Stanford University. The principal investigator is Geoffrey D Abrams, MD at Stanford University. The trial plans to enroll 76 participants.