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

  • STATUS
    Recruiting
  • End date
    Feb 29, 2024
  • participants needed
    76
  • sponsor
    Stanford University
Updated on 4 October 2022
analgesics
analgesic
orthopedic surgery
NSAID
knee surgery
low-dose aspirin

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.

Details
Condition Knee Injuries, Shoulder Injuries, Pain, Postoperative
Treatment Endonovo SofPulse
Clinical Study IdentifierNCT04109638
SponsorStanford University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects may be male or female greater or equal to 18 years of age (≥ 18) at the time of consent
Subjects who will be having shoulder or knee surgery are permitted
Subject must not have used NSAIDs for one (1) week prior to surgery
a. Low-dose aspirin (81 mg) is permitted
Subject must be willing and able to participate in post-operative physical therapy
Subject must understand and be willing to sign the IRB-approved Informed Consent Document
exercises

Exclusion Criteria

Subject has a known collagen disorder such as, but not limited to, osteogenesis imperfecta (OI) or Ehlers-Danlos syndrome (EDS)
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
Subject has a metabolic bone disease such as Paget's disease or osteomalacia as documented in the medical record
Subject has a deltoid defect, deltoid palsy or any other pseudoparalysis
Subject is diabetic
Subject has HIV or hepatitis
Subject has a diagnosis of fibromyalgia or other chronic pain syndrome
Subject has shoulder or knee pain of unknown etiology
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)
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
Subject is septic, or has a local or systemic infection
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
Prescriptive medical marijuana is not permitted, including CBD oils
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
Subject consumes more than 14 (men) or 7 (women) standard drinks (alcoholic units) per
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
week where a drink equals a 12 oz. beer, or a 5 oz. glass of wine, or a 1.5
Subjects who have coexistent cervical spinal pathologies such as radiculopathies or myelopathies
oz. shot of liquor
Subject has a mental or physical condition that would prevent them from complying with the study protocol
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