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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Shoulder Injuries; Knee Injuries
• Intervention / Treatment: Device: Endonovo SofPulse

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Xiao, BS; Phone Number: 6507230003; Email: mxiao@stanford.edu

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Endonovo tPEMF Device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in narcotic pain medicine use at 10 days	Pain medication will be documented every 24 hours.	10 days

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Endonovo
• Investigators: Principal Investigator: Geoffrey D Abrams, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PEMF
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Leg Injuries; Pain, Postoperative; Wounds and Injuries; Shoulder Injuries; Knee Injuries
• Other Study ID Numbers: 53013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes