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

Last updated: April 8, 2025
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Knee Injuries

Treatment

Endonovo SofPulse

Clinical Study ID

NCT04109638
53013
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Subjects may be male or female greater or equal to 18 years of age (≥ 18) at thetime 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 therapyexercises.

  5. Subject must understand and be willing to sign the IRB-approved Informed ConsentDocument.

Exclusion

Exclusion Criteria:

  1. Subject has a known collagen disorder such as, but not limited to, osteogenesisimperfecta (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, rheumatoiddisease, or calcific tendonitis of the shoulder.

  3. Subject has a metabolic bone disease such as Paget's disease or osteomalacia asdocumented 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 oron-going neoplastic disease, except for benign skin cancer(s).

  10. Subject has undergone administration, within 30 days prior to surgery, of any typeof corticosteroid (with the exception of asthma medications and ophthalmicmedications), 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 recreationaldrugs 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 orfor an injury that has occurred more than 12 months prior to enrollment in thisstudy or subjects who are currently in litigation or who have a history oflitigation 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/orindependently completing the patient reported outcomes measures.

  16. Subjects who have coexistent cervical spinal pathologies such as radiculopathies ormyelopathies.

  17. Subject has a mental or physical condition that would prevent them from complyingwith the study protocol.

Study Design

Total Participants: 76
Treatment Group(s): 1
Primary Treatment: Endonovo SofPulse
Phase:
Study Start date:
February 01, 2021
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Stanford University

    Redwood City, California 94063
    United States

    Active - Recruiting

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