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

NCT04109638 | Recruiting FDA Device

• 1 other identifier: 53013
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries; Shoulder Injuries; Pain, Postoperative

Keywords

PEMF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean change from baseline in narcotic pain medicine use at 10 days

  10 days

Study Arms (2)

Active PEMF Group

ACTIVE COMPARATOR

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

Placebo PEMF Group

SHAM COMPARATOR

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

Interventions

Endonovo SofPulse DEVICE

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.

Also known as: Endonovo tPEMF Device

Active PEMF Group; Placebo PEMF Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. a. Low-dose aspirin (81 mg) is permitted.
• Subject must be willing and able to participate in post-operative physical therapy exercises.
• Subject must understand and be willing to sign the IRB-approved Informed Consent Document.

You may not qualify if:

• 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.
• a. Prescriptive medical marijuana is not permitted, including CBD oils.
• 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.
• 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.

Sponsors & Collaborators

• Stanford University: lead
• Endonovo: collaborator

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

RECRUITING

MeSH Terms

Conditions

Knee Injuries; Shoulder Injuries; Pain, Postoperative

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Geoffrey D Abrams, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Xiao, BS

CONTACT

6507230003; mxiao@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: September 30, 2019
• Study Start: February 1, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)