Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109638
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
Endonovo
Information provided by (Responsible Party):
Geoffrey Abrams, Stanford University

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.

Condition or disease Intervention/treatment Phase
Knee Injuries Shoulder Injuries Pain, Postoperative Device: Endonovo SofPulse Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active PEMF Group
Participants will have a 1 in 2 chance to get the active treatment device post-operatively. The device will be attached to the post-operative dressing. The device is an Endonovo SofPulse that emits a pulsed electromagnetic field (PEMF). Single blind randomization.
Device: Endonovo SofPulse
The active device emits PEMF signal whereas the placebo device does not emit a PEMF signal. The active device is on for 15 minutes at a time, every two hours, for 10 days.
Other Name: Endonovo tPEMF Device

Sham Comparator: Placebo PEMF Group
Participants will have a 1 in 2 chance to get the placebo treatment device post-operatively. The device will be attached to the post-operative dressing. The Endonovo SofPulse placebo device does not emit a pulsed electromagnetic field (PEMF). Single blind randomization.
Device: Endonovo SofPulse
The active device emits PEMF signal whereas the placebo device does not emit a PEMF signal. The active device is on for 15 minutes at a time, every two hours, for 10 days.
Other Name: Endonovo tPEMF Device




Primary Outcome Measures :
  1. Mean change from baseline in pain scores on the visual analog scale (VAS) at 10 days [ Time Frame: 10 days ]
    The VAS is a subjective pain scale from 0 to 10, with 0 representing no pain.


Secondary Outcome Measures :
  1. Mean change from baseline in narcotic pain medicine use at 10 days [ Time Frame: 10 days ]
    Pain medication will be documented every 24 hours.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109638


Contacts
Layout table for location contacts
Contact: Michelle Xiao, BS 6507230003 mxiao@stanford.edu

Locations
Layout table for location information
United States, California
Stanford University Recruiting
Redwood City, California, United States, 94063
Sponsors and Collaborators
Stanford University
Endonovo
Investigators
Layout table for investigator information
Principal Investigator: Geoffrey D Abrams, MD Stanford University
Layout table for additonal information
Responsible Party: Geoffrey Abrams, Assistant Professor of Orthopaedic Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT04109638    
Other Study ID Numbers: 53013
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Geoffrey Abrams, Stanford University:
PEMF
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Knee Injuries
Shoulder Injuries
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Leg Injuries